Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia

Last updated: March 13, 2025
Sponsor: VA Office of Research and Development
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Spinal Cord Disorders

Limb Spasticity

Treatment

Motor Task

sham-TESS

Training

Clinical Study ID

NCT05157282
B3715-R
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

In support of the long-term goal of developing new strategies to increase limb function after SCI, the objectives of this proposal are to: 1) Examine the behavioral and physiological effects of TESS on upper-limb muscles after cervical SCI; and 2) Maximize the recovery of reaching and grasping potential by using tailored TESS in a task-specific manner with motor training. Veterans with cervical spinal injuries and healthy volunteers will be recruited for this study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Inclusion criteria for SCI:

  • Male and female Veterans between 18-70 years

  • Chronic SCI (1 year of injury)

  • Cervical injury at C8 or above - damage between cervical spinal segments will beconfirmed using MRI [preliminary data (Benavides et al., 2020) and analysis of MRIsin ~100 participants with cervical SCI confirm that the investigators can meet ourrecruitment goals. Note that most SCI in humans damage several spinal cord segments

  • Verification of damage to cervical spinal segments will ensure that TESSelectrodes will target the injured spinal cord (Benavides et al., 2020)

  • Intact or impaired, but not absent, innervations in dermatomes C6, C7 and C8 duringlight touch and pin prick stimulus using the International Standards forNeurological Classification of Spinal Cord Injury (ISNCSCI) sensory scores as testedbefore in our studies (Bunday and Perez, 2012; Bunday et al., 2018; Benavides etal., 2020; Jo and Perez, 2020)

  • Able to produce a visible power grip with one hand

  • Can score a minimum of two (2) in the cylindrical grasp the "Prehension Ability"GRASSP

  • This criterion was selected to ensure that hand impairment will not interferewith the ability to perform training and the proposed tests

Inclusion criteria for controls:

  • Males and females (18-70 years)

  • Right-handed

  • Able to complete grasping

Exclusion

Exclusion Criteria:

Exclusion criteria for SCI and control subjects:

  • Uncontrolled medical problems including pulmonary, cardiovascular or orthopedicdisease

  • Any debilitating disease prior to the SCI that caused exercise intolerance

  • Premorbid, ongoing major depression or psychosis, altered cognitive status

  • History of head injury or concussion, skull fractures (or any skull deficit),unexplained headaches in the last 6 months, or stroke

  • Pacemaker

  • Metal plate in skull

  • History of seizures

  • Receiving drugs acting primarily on the central nervous system, which lower theseizure threshold, such as antipsychotic drugs (chlorpromazine, clozapine) ortricyclic antidepressants

  • Pregnant females

  • Ongoing cord compression, or a syrinx in the spinal cord, or one who suffers from aspinal cord disease such as spinal stenosis, spina bifida, or herniated cervicaldisk

Study Design

Total Participants: 86
Treatment Group(s): 4
Primary Treatment: Motor Task
Phase:
Study Start date:
January 25, 2023
Estimated Completion Date:
November 04, 2025

Study Description

Current studies demonstrate that electrical spinal stimulation, either invasive or noninvasive, can play an important role in rehabilitation strategies aimed at improving limb function in humans with SCI (Taccola et al., 2018). Among current stimulation strategies, one of the most promising candidates to emerge in recent years is transcutaneous electrical spinal stimulation (TESS). TESS is a noninvasive technique that can be tailored to the needs of each individual, where several segments of the spinal cord can be stimulated at the same time, and delivery can be programed to interact with a rehabilitation strategy during functional movements, such as reaching or grasping. A key element to TESS is its ability to access spared spinal cord networks with minimal discomfort. Although promising, the knowledge of TESS remains limited in scope and more studies are needed to further identify its efficacy.

In Aim 1, subjects will participate in two randomized sessions: 1) TESS, and 2) sham-TESS.] In Aim 2, the investigators will examine the effect of stimulation and training for a total of 20 sessions (3 to 5 per week). Participants will be randomly assigned to: [1) Closed-loop TESS applied during grasping + training, or 2) Closed-loop TESS applied during reaching + training.]

AIM 1 Subjects with SCI and without SCI (controls) will participate in two testing sessions, separated by 2-3 days, using a crossover design. In each session, TESS or sham-TESS will be applied over the cervical spinal cord. Functional and physiological measures will be acquired before and after each session.

AIM 2 Develop methodologies to promote recovery of reaching and grasping movements. To accomplish this goal, the investigators will combine TESS applied in a closed-loop manner with massed practice upper-limb training. Participants will be assigned to one of three groups in a randomized order using a sham controlled design: [1) Closed-loop TESS applied during grasping + training, 2) Closed-loop TESS applied during reaching + training, and 3) Closed-loop TESS applied during grasping & reaching + training.] TESS for 20-min will be followed by 60 min of massed practice exercise training (total=20 sessions).

Connect with a study center

  • Shirley Ryan AbilityLab

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Edward Hines Jr. VA Hospital, Hines, IL

    Hines, Illinois 60141-3030
    United States

    Active - Recruiting

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