Active — Not RecruitingEarly Phase 1

Rebuilding Inter-limb Transfer in Cervical SCI

United States17 participantsStarted 2024-02-15

Plain-language summary

The purpose of this study in people living with cervical Spinal Cord Injury (SCI) is to examine the effects of paired neurostimulation (i.e., PCMS) combined with contralateral motor training on inter-limb transfer of ballistic motor and hand dexterity skills.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Neurological Level of Injury C4, C5, C6, C7, C8 * American Spinal Injury Association Impairment Scale (AIS) C-D * greater than or equal to 1 year time post injury * residual motor sparing of bilateral FDI muscles, defined as medical research council (MRC) grade 2 to 5 Exclusion Criteria: * contraindications to transcranial magnetic stimulation (TMS) and peripheral nerve stimulation (PNS) including pacemaker, metal in the skull, seizure history, pregnancy, etc. * history of alcohol and/or drug abuse * current usage of medications that can potentially lower the seizure threshold such as bupropion, amphetamines, etc. * history of other neurological conditions such as stroke, Parkinson's, and traumatic brain injury (TBI) * active pressure ulcers to avoid disruption of ongoing medical treatments * participation of on-going upper-limb therapies to minimize confounding effects * excessive tone/spasticity (Modified Ashworth Scale \[MAS\] \>3) and severe contractures or soft tissue shortening at elbow/wrist/fingers

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in ballistic acceleration

Timeframe: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours

Change in excitability of cortical and corticospinal physiology and interhemispheric connections (TMS)

Timeframe: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours

Change in excitability of spinal physiology (F-wave)

Timeframe: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours

Trial details

NCT IDNCT06440538

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-30

View on ClinicalTrials.gov More Cervical Spinal Cord Injury trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in ballistic acceleration

Timeframe: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours

Change in excitability of cortical and corticospinal physiology and interhemispheric connections (TMS)

Timeframe: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours

Change in excitability of spinal physiology (F-wave)

Timeframe: Baseline to post paired TMS and PNS stimulation, assessed for approximately 4-6 hours