Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia

NCT05423600 | Recruiting DMC

• 2 other identifiers: HM2002345390SIMS0014-01-00
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Tetraplegia/Tetraparesis

Keywords

Spinal Cord Injury

Outcome Measures

Primary Outcomes (6)

• Change in hand functional activities

  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.

  Baseline to 20 weeks

• Change in maximum grip strength without TS

  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

  Baseline to 20 weeks

• Change in maximum grip strength with TS

  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

  Baseline to 20 weeks

• Change in electrical activity activation with TS

  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.

  Baseline to 20 weeks

• Change in EMG activation without TS

  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.

  Baseline to 20 weeks

• Change in tactile perception

  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.

  Baseline to 20 weeks

Secondary Outcomes (4)

• Changes in capacity to perform functional activities

  Baseline to 20 weeks

• Change in vital capacity

  Baseline to 20 weeks

• Change in ventilatory muscle strength

  Baseline to 20 weeks

• Change in heart rate variability

  Baseline to 20 weeks

Study Arms (2)

BES+TS

EXPERIMENTAL

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: BES + TS

BES+sham TS

EXPERIMENTAL

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)

Procedure: Experimental: BES+sham TS

Interventions

BES + TS PROCEDURE

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)

BES+TS

Experimental: BES+sham TS PROCEDURE

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)

BES+sham TS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study.
• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator
• ACL Administration for Community Living: collaborator

Study Sites (3)

Sheltering Arms Physical Rehabilitation Centers

Richmond, Virginia, 23226, United States

RECRUITING

Richmond VA Medical Center

Richmond, Virginia, 23249, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Quadriplegia; Spinal Cord Injuries

Interventions

BES

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ashraf Gorgey, MPT, PhD, FACSM, FACRM

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashraf Gorgey, MPT, PhD, FACSM, FACRM

CONTACT

804-675-5000; Ashraf.Gorgey@va.gov

Refka Khalil

CONTACT

804-675-5000; Refka.Khalil@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 21, 2022
• Study Start: June 15, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)