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 range18 Years – 75 Years

SexALL

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

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 range18 Years – 75 Years

SexALL

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