NCT05157282 Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia
| NCT ID | NCT05157282 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2023-01-25 |
| Primary Completion | 2027-01-29 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 86 participants in total. It began in 2023-01-25 with a primary completion date of 2027-01-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Monica A Perez, PhD
PRINCIPAL INVESTIGATOR
Edward Hines Jr. VA Hospital, Hines, IL
Frequently Asked Questions
Who can join the NCT05157282 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05157282 currently recruiting?
Yes, NCT05157282 is actively recruiting participants. Contact the research team at mperez04@sralab.org for enrollment information.
Where is the NCT05157282 trial being conducted?
This trial is being conducted at Chicago, United States, Hines, United States.
Who is sponsoring the NCT05157282 clinical trial?
NCT05157282 is sponsored by VA Office of Research and Development. The principal investigator is Monica A Perez, PhD at Edward Hines Jr. VA Hospital, Hines, IL. The trial plans to enroll 86 participants.