Using spinal cord stimulation to improve movement in people with tetraplegia
Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia
This study is testing if a new type of electrical stimulation can help improve arm movement in people with spinal cord injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05157282 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the effects of transcutaneous electrical spinal stimulation (TESS) on upper-limb function in individuals with cervical spinal cord injuries (SCI). Participants, including veterans with chronic cervical injuries and healthy volunteers, will undergo randomized sessions of TESS and sham-TESS to assess its impact on motor function during tasks like reaching and grasping. The study will also involve tailored TESS combined with motor training over 20 sessions to maximize recovery potential. The goal is to enhance limb function through a noninvasive approach that stimulates specific spinal cord segments.
Who should consider this trial
Good fit: Ideal candidates include male and female veterans aged 18-70 with chronic cervical spinal cord injuries at C8 or above.
Not a fit: Patients with complete loss of innervation in the relevant dermatomes or those with injuries not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve motor function and independence for patients with tetraplegia.
How similar studies have performed: Previous studies have shown promise with spinal stimulation techniques, but the specific application of TESS in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois and 1 other locations
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (Recruiting)
- Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Monica A Perez, PhD — Edward Hines Jr. VA Hospital, Hines, IL
- Study coordinator: Monica A Perez, PhD
- Email: mperez04@sralab.org
- Phone: (312) 238-2886
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.