Using spinal cord stimulation to improve movement in people with tetraplegia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.