Spinal stimulation and exercise may restore hand function in paralysis
NCT ID NCT05423600
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This study investigates whether a home-based, telehealth-supported program combining blood flow restricted exercise and transspinal stimulation can improve hand and arm function in people with chronic, incomplete tetraplegia. Participants will perform task-specific activities while receiving either real or sham spinal stimulation. The goal is to see if this combination leads to better grip strength, hand coordination, and sensory perception compared to exercise alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Blood flow restriction enhanced neuromuscular electrical stimulation and transspinal stimulation
- What this could lead to
- If successful, this approach could offer a home-based therapy to improve hand and arm function in people with tetraplegia, enhancing independence.
- What could go wrong
- This is an early-stage study with a small number of participants, so results may not apply to everyone. The therapy requires a companion for assistance, which may limit accessibility.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. A written clearance from the study medical doctor to ensure that the participant is safely able to engage in the study. 2. Participants must have a companion that will be able to help him/her throughout the study. 3. Greater than 1-year post SCI, neurologic level of C8 or above. 4. American Spinal Injury Association Impairment Scale (AIS) scores of B, C, or D indicating presence of an incomplete SCI. 5. Visible muscle contraction response to NMES wrist extensors, bilaterally. 6. 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. 7. Response of muscle contraction of wrist extensors bilaterally to neuromuscular electrical stimulation. Exclusion Criteria: 1. Unhealed fracture in upper or lower extremities. 2. 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. 3. High resting blood pressure greater than 140/80 mmHg. 4. Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons. 5. 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. 6. Implanted pacemakers and/or implanted defibrillator devices. 7. 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. 8. Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study. 9. Other exclusion criteria at the discretion of the medical team may include: 1. Uncontrolled autonomic dysreflexia (AD), refers to episodes of AD that do not respond to medications to ensure stable blood pressure in persons with SCI 2. Concurrent severe neurological injuries other than SCI: MS, CP, severe TBI, and stroke. 3. Unresolved deep vein thrombosis. 4. Psychiatric or cognitive impairments that preclude adherence to the intervention. 5. Known cardiac pathology that precludes safe participation. 6. Metabolic conditions such as cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin. 7. Presence of pressure sores stage three or greater. 8. Presence of a symptomatic urinary tract infection. 9. Severe spasticity as assessed by the Modified Ashworth Scale. 10. Changing neurologic status due to conditions such as progressive posttraumatic syringomyelia.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Richmond VA Medical Center
RECRUITINGRichmond, Virginia, 23249, United States
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Sheltering Arms Physical Rehabilitation Centers
RECRUITINGRichmond, Virginia, 23226, United States
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Virginia Commonwealth University
RECRUITINGRichmond, Virginia, 23298, United States
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