Recruiting

Spinal Cord Stimulation

Sponsor:

VA Office of Research and Development

Code:

NCT05157282

Conditions

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

TESS

Training

Motor Task

sham-TESS

Study Details

Brief 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.

Conditions

Spinal Cord Injury

Study ID

NCT05157282

Start date

Jan 25, 2023

Status verified date

Jan, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Jan 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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 be confirmed using MRI \[preliminary data (Benavides et al., 2020) and analysis of MRIs in \~100 participants with cervical SCI confirm that the investigators can meet our recruitment goals. Note that most SCI in humans damage several spinal cord segments

  • Verification of damage to cervical spinal segments will ensure that TESS electrodes will target the injured spinal cord (Benavides et al., 2020)
  • Intact or impaired, but not absent, innervations in dermatomes C6, C7 and C8 during light touch and pin prick stimulus using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) sensory scores as tested before in our studies (Bunday and Perez, 2012; Bunday et al., 2018; Benavides et al., 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 interfere with 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 Criteria:

Exclusion criteria for SCI and control subjects:

  • Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
  • 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 the seizure threshold, such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants
  • Pregnant females
  • Ongoing cord compression, or a syrinx in the spinal cord, or one who suffers from a spinal cord disease such as spinal stenosis, spina bifida, or herniated cervical disk

Study Design

Enrollment

86 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active TESS Group 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, active transcutaneous electrical spinal stimulation (TESS) will be applied over the cervical spinal cord. Functional and physiological measures will be acquired before and after each session.

sham comparator: Sham TESS Group 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, sham transcutaneous electrical spinal stimulation (sham-TESS) will be applied over the cervical spinal cord. Functional and physiological measures will be acquired before and after each session.

active comparator: Active TESS + Training

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 for a 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).

Interventions

TESS

Small stimulation pulses will be given to the spine at C5-6 in a non invasive manner.

Training

The participant will be instructed to do repetitive motor movements with their arm or hand.

Motor Task

Participants will be asked to perform specific motor tasks or movements with their fingers, hands, and arms.

sham-TESS

Small sham stimulation pulses will be given to the spine at C5-6 in a non invasive manner.

Primary outcome measure

  • Changes in amplitude of Motor evoked potential size [ Time Frame: Change from baseline at study completion, average of 5 weeks ]
  • Change in GRASSP Test [ Time Frame: Through study completion(average of 5 weeks) and during 6-month follow-up ]
  • Changes in amplitude of cervicomedullary motor evoked potential size [ Time Frame: Change from baseline at study completion, average of 5 weeks ]

Central Contacts and Locations

Central contacts

Monica A Perez, PhD

(312) 238-2886mperez04@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Monica A Perez, PhD

312-238-2886mperez04@sralab.org

Edward Hines Jr. VA Hospital, Hines, IL

Recruiting

Hines, Illinois, United States, 60141-3030

Contacts

Bing Chen, PhD MD MEd

(312) 238-7895bing.chen@va.gov

Principal Investigator:

Monica A Perez, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Keywords

  • Spinal Cord Injury
  • Motor Function
  • Reaching
  • Grasping
  • Hand Movement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-01-16.