ISPOR-FDA Summit 2020: Using Patient-Preference Information (PPI), in Medical Device Regulatory Decisions: Benefit-Risk and Beyond. This summit is hosted by the U.S. Food and Drug Administration’s(FDA), Center for Devices and Radiologic Health (CDRH), and is co-sponsored by the International Society of Pharmacoeconomics & Outcome Research (ISPOR). It is a one-day event on March 31, 2020 on the FDA White Oak Campus. In-person registration is free and the meeting will be webcasted

Here is the link: : https://www.ispor.org/conferences-education/conferences/upcoming-conferences/ispor-fda-summit-2020/about/registration-information.

Prior to the workshop is a webinar that talks about what PPI is. We encourage you and your members to tune in.
https://www.ispor.org/conferences-education/education-training/virtual/webinars/patient-preference-information-what-it-is-and-what-it-is-not)

Attend to learn more about Patient Preference Information.

SCI RAC Glossary

GO TO A B C D E F G H I J K L M N O P Q R S T U V W X Y Z RESET

Accelerated approval – an approval pathway in the U.S. for drugs intended to treat serious conditions that have no approved alternatives, in which drugs can be approved after only Phase I or Phase II studies if the studies show the drug is safe and reasonably likely to be effective. See also conditional approval.
Activity-based therapy (or ABT) - consists of movements that occur in your daily life using large groups of muscles working together throughout the body. It includes load-bearing exercises and task-specific movements that are performed at a high intensity with high repetitions and frequency.
Acute intermittent hypoxia (AIH) – is an emerging rehabilitation technique that uses repetitive consumption of low oxygen air followed by ambient room air breathing to induce a genetic response that primes neurons to grow.
Acute phase of SCI – begins immediately after the injury and can last days. Neurons and glial cells are physically injured and/or dying because of direct trauma. See also “subacute phase of SCI” and “chronic phase of SCI.”
Adult stem cells, ASC – found in a tissue or organ and can differentiate to yield the specialized cell types of that tissue or organ.
AMPA – type of glutamate receptors whose activation results in the influx of sodium ions.
Apoptosis (ay-POP-toe-sis) – a process of programmed cell death that rids the body of diseased or damaged cells without triggering inflammation and other damaging processes.
ASIA Impairment Scale – is a standardized neurological examination used by the rehabilitation team to assess the sensory and motor levels which were affected by the spinal cord injury. The scale has five classification levels, ranging from complete loss of neural function in the affected area to completely normal.
Assays – a quantitative determination of the amount of a given substance in a particular sample.
Asteatotic eczema – development of very dry skin, particularly on the lower limbs below the level of injury.
Astrocytes – a star-shaped glial cell in the brain and spinal cord that provides nutrients to neurons, holds neurons in place, and participates in repairing damage after an injury.
Atelectasis (at-uh-LEK-tuh-sis) – failure of the lung to expand (inflate) completely.
Autonomic dysreflexia – a potentially dangerous and, in rare cases, lethal clinical syndrome that develops in individuals with spinal cord injury, resulting in high blood pressure.
Autonomic nervous system – a control system that acts largely unconsciously and regulates bodily functions, such as the heart rate, digestion, respiratory rate, pupillary response, urination, and sexual arousal.
Axon – a fiber-shaped part of the neuron that carries electrical signals from the soma, or cell body, to the axon terminals.
Axon Collateral – these are side branches that axons typically develop to send information to other neurons.
Axon terminal – branch-like structures at the end of an axon that transmits the signal to the dendrites of the next neuron in the relay.
Basic research – the foundation of medical discovery. Through it, key information about the fundamental biological, molecular, and chemical processes of life is learned.
Bias – deviation from the truth, causing distorted results and wrong conclusions. Can occur at any phase of your research, including during data collection, data analysis, interpretation, or publication.
Biologic – a drug made of molecules that are produced by a living organism, e.g., antibodies and other proteins.
BLA, Biologics License Application – the application a drug sponsor submits to FDA to seek approval of a drug candidate that is a biologic.
Blinding, blinded trial – a type of study in which the patients (single-blinded) or the patients and their doctors (double-blinded) do not know which drug or treatment is being given.
BMSC, bone marrow stem cells – heterogeneous population of cells within the bone marrow with the capacity for self-renewal.
Bradycardia (brad-ee-kaa-dee-uh) – is a condition where your heart beats fewer than 60 times per minute, which is unusually slow.
Brain Interface - an emerging tool that seeks to read and interpret the brains intent to move and translates that into action in the environment, such as having a robotic arm that can interact with the environment.
Breakthrough Therapy Designation – a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
Bronchitis (brong-ky-tis)– an infection in the tubes that lead to the air sacs in the lungs.
Calpain – family of protease enzymes that break down other proteins and is regulated calcium influx into cells.
Carpal tunnel syndrome – a compression of one of the large nerves of your arm at the level of the wrist and this can cause numbness, tingling, a burning pain or weakness of your fingers as this nerve controls some of the motion of your hand.
Cartilage – is a strong, flexible connective tissue that acts as a shock absorber throughout your body. Cartilage at the end of your bones reduces friction and prevents them from rubbing together when you use your joints.
Caspase – a family of protease enzymes playing essential roles in programmed cell death.
Ceiling effect – a limitation that places a maximum level of what can be achieved.
Cell differentiation – the process during which young, immature (unspecialized) cells take on individual characteristics and reach their mature (specialized) form and function.
CNS, central nervous system – includes the brain and spinal cord. The CNS controls what we think, how we feel, and what we do.
Cervical region – carry signals to and from the head, neck, diaphragm, shoulders, and parts of the arms, wrist and hand. The cervical region includes the seven vertebrae from C1 through C7, and eight nerves from C1 through C8.
Chemokines – One of a large group of proteins made by certain immune cells and other cells in the body that play an important role in the body's immune response.
Chrondroitinase ABC (kun-DROY-ten-ace) – in vivo it cleaves off the side chains of molecules known as chondroitin sulfate proteoglycans (CSPGs), which can lead to the enhancement of axon growth and functional recovery after SCI.
Chronic phase of SCI – the final phase of secondary injury, which begins months after an SCI and continues indefinitely. See also “acute phase of SCI” and “subacute phase of SCI.”
Chronic Kidney Disease, CKD – is a condition in which the kidneys are damaged and cannot filter blood as well as they should.
Class I devices – medical devices that have the simplest design and almost no likelihood of causing an injury or illness from their use.
Class II devices – medical devices with more complex designs, whose use presents minimal risk of causing injury or illness.
Class III devices – very complex medical devices that are intended to support or sustain human life and are therefore capable of posing substantial risks.
Clinical endpoints – objective, quantitative measurements of clinical symptoms or other physical phenomena.
Clinical trial – research studies that test whether drugs are safe and how they work in people who are either healthy volunteers or patients.
Clonus (kloh-nuhs) – muscular spasm involving repeated, often rhythmic, contractions.
Coagulation disorders – when the body has issues controlling blood clots.
Common Data Elements – standardized key terms or concepts, established so that they may be used in clinical research or in studies to enhance data quality so that data can be used across sites and over time.
Conditional approval – an approval pathway in Europe for drugs intended to treat serious conditions that have no approved alternatives, in which drugs can be approved after only Phase I or Phase II studies if the studies show the drug is safe and reasonably likely to be effective. See also accelerated approval.
Consumer Advisory Boards – A team of lived experience advisors who provide feedback, guidance and input.
Contracture – permanent tightening of the muscles, tendons, skin, and nearby tissues that causes the joints to shorten and become very stiff.
Controls, controlled trials – an experiment or observation designed to minimize the effects of variables other than the independent variable (i.e., confounding variables). This increases the reliability of the results, often through a comparison between control measurements and the other measurements.
CRO, Contract Research Organization – a company that specializes in conducting research studies, including clinical trials, on behalf of clients, including drug and device sponsors.
Complete injury – occurs when a person loses all sensory and motor function below the level of the spinal cord injury. See also “incomplete injury”.
Coronary artery disease, CAD - is a narrowing or blockage of your coronary arteries, usually due to plaque buildup.
CSPGs, Chondroitin sulfate proteoglycans – molecules that are made by by cells including astrocytes inside the glial scar and that inhibit the growth of axons inside and around the damaged area.
Cyst – the fluid filled cavity that remains inside the glial scar after damaged tissues and cells have been broken down.
Cytokines – are small proteins that are crucial in controlling the growth and activity of other immune system cells and blood cells.
Deep vein thrombosis, DVT – occurs when a blood clot (thrombus) forms in one or more of the deep veins in the body, usually in the legs.
Dendrite (den-dryt) – tree-like structures at the end of a neuron that receive chemical signals from other neurons and transmit them toward the cell body, or soma.
Denervation – any loss of nerve supply.
Depolarization – a change within a cell, during which the cell undergoes a shift in electric charge distribution, resulting in a positive charge flow into the cell.
Discovery – the earliest stage of drug R&D, when researchers identify molecules that have chemical and biological properties that could treat a health condition.
Dose – a quantity of a medicine or drug taken or recommended to be taken at a particular time.
Drug sponsor – the developer of a drug, usually but not always a pharmaceutical company.
Drug Candidate – a compound (small molecule, antibody, etc.) with strong therapeutic potential and whose activity and specificity have been optimized.
Drug Development Pathway – the process of bringing a new drug molecule into clinical practice. In its broadest definition this encompasses all steps from the basic research process of finding a suitable molecular target to supporting the commercial launch of the drug.
DSMB, Data Safety Monitoring Board – a scientific committee that monitors data from an ongoing clinical trial to determine whether the study should continue.
Edema – swelling caused by excess fluid trapped in your body's tissues.
Efficacy – defined as the ability to do what is defined as desired or to be effective at producing a result.
Embryonic stem cells, ESCs – found only in embryos during the earliest stages of human development and have the ability to make all other types of cells in the body.
Endpoint – a measure of efficacy in a research study.
Epidural spinal cord stimulation, eSCS – a treatment, requiring a surgical procedure to implant electrodes close to the spinal cord, specifically on top of the dura mater, to send electrical signals to stimulate the nervous system.
Excitotoxicity – a phenomenon in which excess glutamate over-stimulates neurons, causing damage or neuron death.
Exclusion – features of the potential study participants who meet the inclusion criteria but present with additional characteristics that could interfere with the success of the study or increase their risk for an unfavorable outcome.
FDA, Food and Drug Administration – the U.S. regulator that oversees clinical testing and drug approvals.
Fibrous – a type of cell that contributes to the formation of connective tissue, a fibrous cellular material that supports and connects other tissues or organs in the body.
Feasibility – an assessment of the practicality of a project or system. Aims to objectively and rationally uncover the strengths and weaknesses of an existing proposed study to achieve the prospect for success.
Free radical – are molecules that are unstable because they have unpaired electrons in their outer shell. Their instability causes them to react with other molecules in potentially damaging ways.
Focus Groups – Moderated and structured group discussions with a targeted group from the SCI Community.
Forced vital capacity, FVC – is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible.
G-CSF, Granulocyte colony-stimulating factor – a biologic drug that is approved as a treatment for neutropenia (or low neutrophil count) and currently another experimental immunomodulatory therapy for SCI.
General controls – the minimum regulatory requirements for medical devices, which include device manufacturing methods, product quality, accurate labeling, and registration with regulatory authorities.
Genitourinary system – Includes the bladder, bowel, and sex organs.
Glial cells – include many different types of cells that have different jobs: some glial cells surround neurons and hold them in place. Some glial cells supply nutrients and oxygen to neurons. There are special types of glial cells that fight infections and remove dead cells. Others help neurons transmit information by producing insulation that protects neurons and improves their ability to send electric signals. Some glial cells also produce chemicals that neurons need to communicate or eliminate chemicals that prevent neurons from communicating. The types of glial cells include oligodendrocytes, astrocytes, microglia, and ependymal cells.
Glial scar – a scar formed by many different immune and glial cells, particularly astrocytes that surrounds the site of spinal cord injury creating a physical barrier around the damaged area that separates healthy cells from injured ones.
Glutamate – a neurotransmitter that is required to transmit signals from one neuron to another.
Grant – an award, usually financial, given by one entity (typically a company, foundation, or government) to an individual or a company to facilitate a goal or incentivize performance.
Grant reviewers – Review submitted SCI research grant proposals for funding bodies such as the Department of Defense or Craig H. Nielsen Foundation.
Gray matter – in the spinal cord, the inner layer that contains neuronal cell bodies, where information is processed locally and transmitted between the central and peripheral nervous systems. When viewed as a cross section, the gray matter looks like a gray butterfly at the center of the spinal cord. See also “white matter.”
Hemorrhage (hem-uh-rij) – a profuse discharge of blood, as from a ruptured blood vessel.
Humanitarian Device Exemption – an approval process provided by the United States Food and Drug Administration allowing a medical device to be marketed without requiring evidence of effectiveness.
Hypothermia – a medical emergency that occurs when your body loses heat faster than it can produce heat, causing a dangerously low body temperature.
Hyperhidrosis – is a common condition in which a person sweats excessively.
IDE, Investigational Device Exemption – an application submitted to regulators for approval to conduct clinical trials of a medical device.
Immunomodulation – manipulating immune cells so that they carry out their restorative functions but not their damaging inflammatory functions.
Impulse – an electrical signal that travels away from the soma through a fiber called the axon.
Inclusion – key features of the target population that the investigators will use to answer their research question.
Incomplete injury – some nerve signals can still be sent along the spinal cord to the brain, even from below the injury site. You may have some movement and sensation with an incomplete injury. See also “complete injury”.
Incontinence – lack of voluntary control over urination and defecation.
In-depth interviews – Highly structured one-on-one interviews with targeted key opinion leaders.
iPSC, Induced Pluripotent Stem Cells– are derived from skin or blood cells that have been reprogrammed back into an embryonic-like pluripotent state that enables the development of an unlimited source of any type of human cell needed for therapeutic purposes.
Inflammation – the immune system’s response to infection or damage. It is necessary to fight off bacteria and viruses, clear cellular debris, and promote wound healing following an injury.
Informed consent – the practice of giving a potential volunteer all the facts about a clinical trial and getting their consent to participate before they join the study.
IKT, Integrated knowledge translation – a model of collaborative research, where researchers work with knowledge users who identify a problem and have the authority to implement the research recommendations.
IKT Guiding Principles – a foundational tool with the potential to improve the relevance and impact of SCI research, mitigate tokenism, and to address this gap between discovery and the application of knowledge.
IND, Investigational New Drug – the application a drug sponsor submits to FDA to seek permission to begin clinical studies in people.
Investigator – a medical professional who is responsible for interacting with and caring for the people who volunteer to participate in trials.
In vitro research – laboratory studies on cells or molecules outside the body.
In vivo research – laboratory studies on living animals.
IRB, Institutional Review Board – a committee of doctors, statisticians, and community members who review clinical trial protocols to ensure they are medically, ethically, and legally acceptable.
Ischemia (i-skee-mee-uh) – restriction in blood supply to any tissue, muscle group, or organ of the body, causing a shortage of oxygen.
Label – a medication package insert approved by FDA that describes the drug, how it is used, how it works, and what is known about its safety and efficacy.
Ligament - a short band of tough, flexible fibrous connective tissue which connects two bones or cartilages or holds together a joint.
Lumbar region – nerves that exit from the segments of the spine in the lower back, which extends from L1 through L5, carry signals to and from the hips, thighs, groin, and lower abdomen.
Macrophage (MACK-row-fahjjez) – specialized immune cells that enter the injured spinal cord from the blood stream, and remain in the injured cord for very long periods after an SCI. Their main job is to ingest dead cells, debris, and foreign pathogens such as bacteria and viruses, and break them down safely in a process called “phagocytosis”.
Maladaptive plasticity - plasticity in the nervous system that can lead to a disruption of the function, consequently heightening pain processing and sensitivity.
Mesenchymal stem cells, MSCs (mez-zenKIME-ul) – are adult stem cells isolated from different sources that can differentiate into other types of cells.
Metabolic disorder – a disorder is which something is wrong with the body's metabolism — the ability to turn food into energy and get rid of waste.
Metabolize, metabolism – sum of the chemical reactions that take place within each cell of a living organism and that provide energy for vital processes and for synthesizing new organic material.
Methylprednisolone – a potent steroid that reduces inflammation.
Microglia – a special type of macrophage acts as the main immune defense in the CNS.
Minocycline – a drug that is approved as an antibiotic, may tackle inflammation and several other biological processes that damage neurons in the aftermath of an SCI through mechanisms that are not yet understood and are not yet proven to work in SCI.
Mitochondria – tiny, complex organelles, or mini-organs, found inside almost all our cells. Their primary function is to produce the cell’s major source of energy, a molecule called “ATP”.
Model – a cell line, tissue sample, or animal used to study disease biology or screen drug candidates.
Motor neurons – send instructions to move from the CNS toward muscles and organs.
Motor root – carry information from the brain to the body. Also known as “ventral root”.
Muscle atrophy – wasting or loss of muscle tissue.
Musculoskeletal – relating to the muscles and skeleton and including bones, joints, tendons, and muscles.
Myelin (MY-uh- lynn) – a fatty coating around axons that provides electrical insulation and physical protection and support.
Myelination – the process of forming a myelin sheath around axons.
Nerve/neuron – relay information back and forth between the brain and body by transmitting electrical and chemical signals.
Nervous system – is a complex network that includes the brain, billions of nerves, and other cells within our bodies that work together to control and coordinate all of our thoughts, emotions, and movements.
Neural network – set of neurons that work together by firing in a circuit.
Neural stem cells – multipotent cells which are able to self-renew and proliferate without limit, to produce progeny cells which terminally differentiate into neurons, astrocytes and oligodendrocytes.
Neural progenitor cells – the progenitor cells of the CNS that give rise to many, if not all, of the glial and neuronal cell types that populate the CNS.
Neuroaxis –the central nervous system as a whole.
Neuroplasticity – the process of retraining neural circuits to adapt functions.
Neuropathic pain – is caused by abnormal communication between the nerves that were damaged by your spinal cord injury and the brain.
Neuroprotection – a treatment strategy that aims to protect the neurons and axons that survive the primary injury to the spinal cord, but may become damaged during the secondary injury. The strategy involves stopping or reversing the biological processes that cause continued damage in the days to weeks after the initial injury.
Neurorepair/Regeneration – stimulate the growth of axons during the subacute or chronic phase of injury.
Neuroreplacement – replacing lost and damaged cells with new ones during the subacute or chronic phase of SCI.
Neurotoxin – synthetic or naturally occurring substances that damage, destroy, or impair the functioning of the central and/or peripheral nervous system.
Neurotransmitters – chemical messengers sent by one neuron to another through the synapse.
Neurotrophic factors – family of biomolecules that support the growth, survival and differentiation of both developing and mature neurons.
Neutropenia – refers to lower-than-normal levels of neutrophils in your blood. See also “neutrophil”.
Neutrophil – short-lived immune cells that act as the first line of defense against infectious pathogens. They clear debris through phagocytosis and play a major role in mounting an inflammatory response.
NDA, New Drug Application – the application a drug sponsor submits to FDA to seek approval of drug candidate that is a small molecule.
NMDA – type of glutamate receptor whose activation results in the influx of calcium ions in addition to sodium ions.
Novel – describe research that has identified phenomena or developed techniques/materials that haven’t been previously reported in the literature.
Olfactory ensheathing cells – are a type of macroglia found in the nervous system that are responsible for the successful regeneration of olfactory axons throughout the life of adult mammals.
Oligodendrocyte (oh-liggo-DEN-droh-site) – a type of glial cell found only in the CNS, which forms a myelin sheath around the axons of neurons.
Onychomycosis – fungal infection often affects the nail.
Orphan indication, orphan disease – a rare health condition, defined by most countries as a condition that affects fewer than 200,000 people.
Orphan drug designation – a regulatory designation that gives financial incentives to drug sponsors that develop drugs to treat an orphan disease.
Osteopenia – is when your bones are weaker than normal but not so far gone that they break easily, which is the hallmark of osteoporosis.
Osteoporosis – a bone disease that develops when bone mineral density and bone mass decreases, or when the quality or structure of bone changes.
Paraplegic – refers to the loss of movement and sensation in both legs and, sometimes, part of the lower abdomen.
Parasympathetic nervous system - is one of the three divisions of the autonomic nervous system that decreases heart rate, blood pressure, breathing rate, and pupil size. It also causes dilation of blood vessels and increases digestive juices.
Paroxysmal hypertension – is episodic and volatile high blood pressure.
Patent – a legal document that gives inventors control over how their inventions — including devices, machines, materials, processes and substances — are made, used and sold for a set period of time.
Patient-reported outcomes, PROs – questionnaires that ask participants to rate various aspects of their lives, such as how they feel physically, mentally, and emotionally, or how easily they can accomplish daily activities.
Peri-neural net – inhibitory molecules, as well as other proteins existing in the extracellular matrix, begin to form a thick net around neurons and their processes, increasing thickness in the lesion.
PNS, peripheral nervous system – consists of neurons that branch out from the spinal cord and transmit information back and forth between our brain and our eyes, ears, nose, mouth, skin, muscles and internal organs.
Phagocytosis – the process by which a cell uses its plasma membrane to engulf a large particle.
Phase 1 – tests the safety, side effects, best dose, and timing of a new treatment. It may also test the best way to give a new treatment (for example, by mouth, infusion into a vein, or injection) and how the treatment affects the body.
Phase 2 – researchers administer the drug to a larger group of patients (typically up to a few hundred) with the disease or condition for which the drug is being developed to initially assess its effectiveness and to further study its safety.
Phase 3 – trials that compare new treatments with the best currently available treatment (the standard treatment).
Phase 4 – clinical trial that studies the side effects caused over time by a new treatment after it has been approved and is on the market.
PK, pharmacokinetics – the way a drug is absorbed, distributed, metabolized and eliminated by the body.
Pivotal study – clinical study seeking to demonstrate the efficiency of a new drug in order to obtain its marketing approval by regulatory authorities (i.e. FDA).
Placebo – an inactive substance or other intervention that looks the same as, and is given the same way as, an active drug or treatment being tested.
Pluripotent – the ability to turn/differentiate into any other cell.
Pneumonia (nyoo-moh-nee-uh) – an inflammatory condition of the lung primarily affecting the small air sacs known as alveoli caused by bacteria, viruses, fungi, or chemical irritants.
Post-Market Approval – studies and/or clinical trials to gather additional information about a product's safety, efficacy or optimal use for drugs and medical devices that are already approved.
Post-synaptic neuron – a neuron that receives information from the synapse.
Preclinical research – experiments that show how the candidates work in cell and animal “models” that simulate a human health condition.
PMA, Premarket Approval – an application for FDA approval of medical devices that require clinical testing, including the highest-risk Class II medical devices, plus all Class III devices.
Pressure sores/ulcers – a wound to the skin and underlying tissues caused by prolonged compression or shearing of the tissues between the skeleton and an external surface such as a chair or bed.
Pre-synaptic neuron – a neuron that sends information into the synapse towards a second, post-synaptic neuron.
Primary endpoint – the main endpoint that must be met in order to consider a trial a success; sometimes other endpoints cannot be analyzed unless the primary endpoint is met.
Primary injury – the physical injury to the spinal cord itself. See also “secondary injury”.
Processes – specific collection of molecular activities carried out, frequently in a highly controlled manner and a specified temporal sequence.
Protease – are enzymes that break down other proteins by cutting, or “cleaving” them.
Protocol – a detailed written plan for a clinical trial that describes every aspect of study design and conduct.
Prototype – an early sample, model, or release of a product built to test a concept or process.
Quadriplegia – refers to the loss of movement and sensation in all four limbs and, sometimes, parts of the chest, abdomen, and back. Also referred to as “tetraplegia”.
Randomization, randomized trial – a study design that randomly assigns participants into an experimental group or a control group.
Receptor – a molecule inside or on the surface of a cell that binds to a specific substance and causes a specific effect in the cell.
Regeneration – refers to re-growth of the cut/injured axon through a lesion back towards its normal target.
Regulator – a government organization that oversees clinical testing and drug approvals.
Research advocate – a person who serves as a link between patients and scientific researchers. They bring a patient perspective on research activities to scientific advisory boards and committees.
Revoke – officially taking back or cancelling some kind of right, status, or privilege that has already been given or approved.
R&D, research and development – the activity of discovering and testing a drug to show that it can treat disease.
Roundtable Discussions – Open brainstorming or exploratory sessions with a team of targeted stakeholders.
Sacrum region – nerves that exit from the segments of the spine nearest the pelvis, which extends from S1 through S5, carry signals to and from the posterior thigh, most of the lower leg and foot, and part of the pelvis.
Schwann cells – a type of glial cell that myelinates neurons in the peripheral nervous system instead of in the CNS and can help damaged neurons regenerate their axons.
Secondary injury – a range of after-effects that cause further damage as the body responds to the primary injury.
Secondary complications – health problems that are distance but related to the original injury.
Sensory neurons— send information about sensations toward the CNS.
Sensory root – carry information from the body to the brain. Also known as “dorsal root”.
Sepsis – a potentially life-threatening condition that occurs when the body's response to an infection damages its own tissues.
Sleep apnea – is a common condition in which your breathing stops and restarts many times while you sleep, which can prevent your body from getting enough oxygen.
Small molecule drug – a drug that is made of molecules that are chemical compound.
Soma – the cell body of a neuron, which functions as its headquarters.
Somatic nervous system – the part of the peripheral nervous system associated with the voluntary control of body movements via skeletal muscle.
Somatotopic organization - Both the motor cortex and sensory cortex are specifically organized in a manner such that one region of the brain is responsible for controlling one muscle, or generating sensation of one area of the body.
Spasticity – a condition in which there is an abnormal increase in muscle tone or stiffness of muscle, which might interfere with movement, speech, or be associated with discomfort or pain.
Speaking engagements – Positioning the voice of advocacy in public platforms such as podium speaking positions, panel discussions, webinars/podcasts or other public forums.
Spinal cord – the communication highway of the body; it connects the brain to the entire body to allow us to move and perceive our environment.
Spinal fluid – clear, colorless body fluid found within the tissue that surrounds the brain and spinal cord of all vertebrates.
Spinal shock – a response to injury in which neurons in the spinal cord are stunned and stop signaling.
Sprouting – splitting of an axon into multiple branches which can occur above a lesion, into a lesion, or below the lesion in axons that have been spared from injury.
Steroid – are a man-made version of chemicals, known as hormones, that are made naturally in the human body.
Stone – is a concretion of material, usually mineral salts, that forms in an organ or duct of the body.
Structural plasticity - changes occurring in a neuron that changes the amount of connections to and from that neuron. This can include sprouting of neurons to make more or alternate physical connections with other cells or to provide more space for other neurons to connect to.
Study Surveys – Design, craft and distribute SCI community surveys to gain quantitative results.
Subacute phase of SCI – follows the acute phase and lasts for weeks. In this phase, injured and dying cells release substances that start a chain reaction of inflammation and cell death. See also “acute phase of SCI” and “chronic phase of SCI”.
Sympathetic nervous system - is one of the three divisions of the autonomic nervous system that increases heart rate, blood pressure, breathing rate, and pupil size. It also causes blood vessels to narrow and decreases digestive juices.
Synapse – the small space between the axon terminal of one neuron and the dendrite of another, through which chemical signals are transmitted.
Synaptic plasticity - changes occurring within a neuron altering how effectively neurons communicate with one another at the location where they make connections.
Target – a molecule or cell that a drug binds to or interacts with to stop, start or change a process that does not work correctly in a disease.
TPP, target product profile – a detailed description of the ideal characteristics of a new drug candidate that is used to guide R&D.
Tendon – is a fibrous connective tissue that attaches muscle to bone.
Tetraplegic – refers to the loss of movement and sensation in all four limbs and, sometimes, parts of the chest, abdomen, and back. Also referred to as “quadriplegia”.
Thoracic region – nerves that exit from the segments of the spine in the area of our ribs and carry signals to and from the hand, chest and abdomen. The thoracic region includes the twelve vertebrae and nerve roots T1 through T12.
Thromboembolism – is a condition that occurs when a blood clot forms in a vein.
Tinea cruris – fungal infection that often affects the groin and inner thighs.
Tinea pedis – fungal infection that often affects the foot, specifically the space between the toes.
Toxicity – the degree to which a chemical substance or a particular mixture of substances can damage an organism.
Tracheostomy – an opening through the neck into the trachea, the main airway to help a person breathe.
Transcutaneous spinal cord stimulation, tSCS – a non-invasive treatment to stimulate the spinal cord from the surface of the skin to send electrical signals to stimulate the nervous system.
Translational Research – process of taking a discovery from the laboratory into the clinic, where it can ultimately help people.
Trauma – an injury, such as a wound, to living tissue caused by an extrinsic agent.
Uncoupling protein – transporters, present in the mitochondrial inner membrane, that work to relieve the build-up of too much charge by creating pores in the mitochondria’s inner membrane that allow hydrogen ions to pass through without producing ATP.
Vagus nerve stimulation, VNS – involves the use of a device to stimulate the vagus nerve with electrical impulses.
Vasodilation – widening of blood vessels.
Venous stasis – a condition in which blood pools, or “stands” particularly in the legs
White matter – in the spinal cord, the outer layer that contains axons that transmit signals. When viewed as a cross section, the white matter looks like a white oval. See also “gray matter”.
Yamanaka factors – group of protein transcription factors that play a vital role in the creation of induced pluripotent stem cells.
510(k) pathway – an FDA approval pathway for medical devices that requires evidence that the new device is “substantially equivalent” in use, design, materials, labeling, and other characteristics, to an existing device, called a “predicate device”.