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Neurostimulation

Neurostimulation and Motor Training for Spinal Cord Injury

Phase < 1
Recruiting
Led By Ela Plow, PhD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Neurological Level of Injury C4, C5, C6, C7, C8
American Spinal Injury Association Impairment Scale (AIS) C-D
Must not have
History of other neurological conditions such as stroke, Parkinson's, and traumatic brain injury (TBI)
Excessive tone/spasticity (Modified Ashworth Scale [MAS] >3) and severe contractures or soft tissue shortening at elbow/wrist/fingers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Summary

"This trial aims to investigate how a combination of neurostimulation and motor training can improve motor skills and hand dexterity in individuals with cervical Spinal Cord Injury."

Who is the study for?
This trial is for individuals with cervical Spinal Cord Injury (SCI) who are interested in improving their motor and hand dexterity skills. Specific eligibility criteria details were not provided, so participants should inquire about inclusion and exclusion requirements.
What is being tested?
The study tests the effects of paired neurostimulation (PCMS) combined with contralateral motor training versus PCMS with rest or sham PCMS plus training on enhancing motor skills in people with SCI.
What are the potential side effects?
Potential side effects were not detailed; however, as this involves neurostimulation and physical training, there may be discomfort, muscle soreness, or fatigue associated with the interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My spinal cord injury is between C4 and C8.
Select...
My spinal injury is moderately to severely impairing.
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I can still move the muscles in my hands, though not fully.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of neurological conditions like stroke or Parkinson's.
Select...
I have severe muscle stiffness and tightness in my elbow, wrist, or fingers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post paired tms and pns stimulation, assessed for approximately 4-6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and post paired tms and pns stimulation, assessed for approximately 4-6 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in ballistic acceleration
Change in excitability of cortical and corticospinal physiology and interhemispheric connections (TMS)
Change in excitability of spinal physiology (F-wave)
Secondary study objectives
Change in Nine Hole Peg Test (NHPT)
Change in finger velocity smoothness during NHPT
Other study objectives
Canadian Occupational Performance Measure (COPM)
Capabilities of Upper Extremity Test(CUE-T)
Edinburgh Handedness Inventory
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: PCMS + Contralateral Motor TrainingExperimental Treatment1 Intervention
Group II: PCMS + RestActive Control1 Intervention
Group III: Sham PCMS + Contralateral Motor TrainingPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,045 Previous Clinical Trials
1,370,658 Total Patients Enrolled
The Craig H. Neilsen FoundationOTHER
58 Previous Clinical Trials
2,975 Total Patients Enrolled
Ela Plow, PhDPrincipal InvestigatorThe Cleveland Clinic
4 Previous Clinical Trials
131 Total Patients Enrolled
~10 spots leftby Jul 2025
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