Rebuilding Inter-limb Transfer in Cervical SCI

NCT06440538 | Active Not Recruiting Early Phase 1 FDA Device

• 1 other identifier: 23-415
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Spinal Cord Injury

Keywords

Cervical Spinal Cord Injury; Upper limb; Motor Training; Brain Stimulation; Peripheral Nerve Stimulation; Hand Dexterity; Inter-limb transfer; Motor learning

Outcome Measures

Primary Outcomes (3)

• Change in ballistic acceleration

  Participants perform 10 trials of ballistic index finger abduction with a accelerometer attached to index finger to capture the peak acceleration during the movement.

  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)

  Transcranial magnetic stimulation will be used to test cortical output from both hemispheres and will be measured as motor evoked potentials(MEPS) of the First Dorsal Interosseous (FDI) muscle.

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

• Change in excitability of spinal physiology (F-wave)

  Peripheral Nerve stimulation will be performed to collect the spinal F-wave amplitude of the First Dorsal Interosseous (FDI) muscle.

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

Secondary Outcomes (2)

• Change in Nine Hole Peg Test (NHPT)

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

• Change in finger velocity smoothness during NHPT

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

Other Outcomes (7)

• TMS safety questionnaire

  Post paired TMS and PNS stimulation, assessed for approximately 4-6 hours

• Capabilities of Upper Extremity Test(CUE-T)

  Baseline

• Canadian Occupational Performance Measure (COPM)

  Baseline

Study Arms (3)

PCMS + Contralateral Motor Training

EXPERIMENTAL

Device: PCMS + Contralateral Motor Training

PCMS + Rest

ACTIVE COMPARATOR

Device: PCMS + Rest

Sham PCMS + Contralateral Motor Training

SHAM COMPARATOR

Device: Sham PCMS + Contralateral Motor Training

Interventions

PCMS + Rest DEVICE

PCMS + Rest will involve delivering 360 pairs of TMS-PNS pulses (30min, 0.2Hz) to the weaker FDI followed by a 30-min rest.

PCMS + Rest

PCMS + Contralateral Motor Training DEVICE

PCMS + Contralateral Motor Training will involve delivering 360 pairs of TMS-PNS pulses (30min, 0.2 Hz) to the weaker first dorsal interosseous (FDI) muscle immediately before a session of ballistic index finger abduction training at the opposite, stronger FDI muscle.

PCMS + Contralateral Motor Training

Sham PCMS + Contralateral Motor Training DEVICE

360 TMS pulses will be delivered at a location 10-cm posterior to the participant's head (into the air, 0.2Hz) and no PNS pulses will be generated, followed by a session of 30-min ballistic index finger abduction training at the opposite, stronger FDI muscle.

Sham PCMS + Contralateral Motor Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

Lerner Research Institute; Cleveland Clinid Foundation

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Ela Plow, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Proffesor

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: June 4, 2024
• Study Start: February 15, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

US (1)