Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05157282

Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-01-25

Completion Date

2027-02-01

Last Updated

2026-01-16

Healthy Volunteers

Yes

Conditions

Spinal Cord Injury

Interventions

DEVICE

TESS

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

OTHER

Training

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

OTHER

Motor Task

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

DEVICE

sham-TESS

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

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

Locations (2)

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States