NCT05423600 · Virginia Commonwealth University
Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia
(SCIMS Main)
What this study is about
The purpose of the current study is to evaluate whether a home-based, telehealth-supported intervention combining Blood Flow Restricted Exercise (BES) and Transspinal Stimulation (TS) will improve motor and functional abilities greater than BES+sham TS in persons with chronic, incomplete tetraplegia.
View original scientific description
The purpose of the current study is to evaluate whether a home-based, telehealth-supported intervention combining Blood Flow Restricted Exercise (BES) and Transspinal Stimulation (TS) will improve motor and functional abilities greater than BES+sham TS in persons with chronic, incomplete tetraplegia.
Interventions
PROCEDURE
BES + TS
Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) treatment plus transspinal stimulation (TS) plus repetitive practice of task-specific activities, also known as massed practice (MP)
PROCEDURE
Experimental: BES+sham TS
Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) sham treatment plus transspinal stimulation (TS) plus repetitive practice of task-specific activities, also known as massed practice (MP)
Primary outcome measures
Change in hand functional activities
Time frame: Baseline to 20 weeks
The grasp and release test is a standardized test of functional activities depending on hand function in persons with cSCI. Participants will be asked to lift and move a peg, block, can, 1 lb. dumbbell weight and fork from lateral to medial over a 60 cm distance and release at midline.
Change in maximum grip strength without TS
Time frame: Baseline to 20 weeks
Using a standard hand-grip dynamometer, participants will be asked to squeeze the dynamometer with one hand at a time as strongly as possible for up to 3 seconds, to obtain a measure of the maximal voluntary force they can generate when closing their hand
Change in maximum grip strength with TS
Time frame: Baseline to 20 weeks
Using a standard hand-grip dynamometer, participants will be asked to squeeze the dynamometer with one hand at a time as strongly as possible for up to 3 seconds, to obtain a measure of the maximal voluntary force they can generate when closing their hand with the addition of TS over the skin targeting the cervical spinal cord
Change in electrical activity activation with TS
Time frame: Baseline to 20 weeks
During the assessment of maximal grip strength with TS, electromyography (EMG) will be used to measure the amount of neuromuscular electrical activation from the following muscle groups: wrist flexors, wrist extensors, elbow flexors, and elbow extensors.
Change in EMG activation without TS
Time frame: Baseline to 20 weeks
During the assessment of maximal grip strength without TS, electromyography (EMG) will be used to measure the amount of neuromuscular electrical activation: wrist flexors, wrist extensors, elbow flexors, and elbow extensors.
Change in tactile perception
Time frame: Baseline to 20 weeks
The Semmes-Weinstein Monofilament Exam is used to assess cutaneous tactile perception in individuals with spinal cord injury to provide more precise assessment of sensory function. Semmes-Weinstein Monofilaments are small, thin fibers attached to a handle that bend once a certain amount of force (ranging from 0.07 - 300 grams) is applied. With eyes closed, participants will be asked whether they can feel a light touch from the monofilaments at standard locations on the palm and dorsum of the hand and fingers. Participants are given a score depending on what the thinnest filament and thus, what the smallest amount of force is which needs to be applied for them to perceive a tactile stimulus.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- A written clearance from the study medical doctor to ensure that the participant is safely able to engage in the study.
- Participants must have a companion that will be able to help him/her throughout the study.
- Greater than 1-year post SCI, neurologic level of C8 or above.
- American Spinal Injury Association Impairment Scale (AIS) scores of B, C, or D indicating presence of an incomplete SCI.
- Visible muscle contraction response to NMES wrist extensors, bilaterally.
- Agreement to use telehealth services for delivery of research exercise training by study staff. Possesses appropriate technology to engage in telehealth including a personal web camera, computer, microphone, speakers, and high-speed broadband internet connection, valid email address (needed to obtain VA issued video conferencing software), and telephone number used to obtain login credentials for the In-Home Video Software - Cisco Jabber Video for Telepresence Software.
- Response of muscle contraction of wrist extensors bilaterally to neuromuscular electrical stimulation.
Exclusion criteria
- Unhealed fracture in upper or lower extremities.
- Severe scoliosis, severe upper extremity contractures, or other musculoskeletal issues that would impede participation in a BES + TS intervention or valid evaluation of outcome measures.
- High resting blood pressure greater than 140/80 mmHg.
- Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons.
- Pregnancy (female participants). A home pregnancy test will be conducted to role out any pregnancy before the study at the McGuire VAMC. The test will be repeated every month during the course of the study.
- Implanted pacemakers and/or implanted defibrillator devices.
- Other exclusion criteria may include the presence of implanted electrical device, cancer, thrombosis, pacemaker, defibrillator, or seizures. Patients who are currently on or receive anti-platelet or anticoagulant medications will be excluded from the trial.
- Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study.
- Other exclusion criteria at the discretion of the medical team may include:
- Uncontrolled autonomic dysreflexia (AD), refers to episodes of AD that do not respond to medications to ensure stable blood pressure in persons with SCI
- Concurrent severe neurological injuries other than SCI: MS, CP, severe TBI, and stroke.
- Unresolved deep vein thrombosis.
- Psychiatric or cognitive impairments that preclude adherence to the intervention.
- Known cardiac pathology that precludes safe participation.
- Metabolic conditions such as cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin.
- Presence of pressure sores stage three or greater.
- Presence of a symptomatic urinary tract infection.
- Severe spasticity as assessed by the Modified Ashworth Scale.
- Changing neurologic status due to conditions such as progressive posttraumatic syringomyelia.
Where
- Richmond, Virginia
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research, ACL Administration for Community Living
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations