CompletedPhase 1/2

Improving SCI Rehabilitation Interventions by Retraining the Brain

United States47 participantsStarted 2019-07-12

Plain-language summary

The Long-term goal of this project is to develop upper limb rehabilitation interventions that can be utilized for cervical Spinal Cord Injury survivors. This Study will utilize a novel method of non-invasive brain stimulation in conjunction with upper limb training given for 15 sessions over several weeks up to 8 weeks. The Study will include the following site visits: * Eligibility Screening and Informed Consent Visit. * Four testing visit in which motor function of the upper limb and neurophysiology will be measured * Fifteen intervention visits during which patients will receive upper limb training in conjunction with non-invasive brain stimulation * Repeat testing of motor function and neurophysiology of the upper limb following completion of intervention visits * a Follow-up visit completed 3 months after the completion of interventions

Who can participate

Age range18 Years – 75 Years

SexALL

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

Inclusion Criteria: * Patients with incomplete (having sparing to muscles in the upper extremities below the level of injury) C1-C8 SCI * at least 1 year post injury * weakness of the triceps or biceps muscle in the weaker upper limb, defined as a clinically detectable difference in power compared to the power of the spared antagonist(biceps and triceps respectively) muscle, i.e., at least one muscle grade lower on the MRC scale. Exclusion Criteria: * contraindications to tDCS and TMS including: pacemaker, metal in the skull, seizure history, pregnancy. * pressure ulcers * traumatic brain injury (TBI), diagnosed based upon acute injury Rancho scale \<5 or positive MRI/CT findings at the time of injury will also be excluded to prevent confounding of TMS metrics. * excessive tone/spasticity and severe contractures or soft tissue shortening at the elbow/wrist * participating in ongoing upper-limb therapies

What they're measuring

Change in Upper Extremity Motor Score (UEMS) With Manual Muscle Testing

Timeframe: Baseline (0 weeks), after intervention (up to 8 weeks)

Change in Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)

Timeframe: Baseline (0 weeks), after intervention (up to 8 weeks)

Change in Canadian Occupational Performance Measure (COPM) Performance

Timeframe: Baseline (0 weeks), after intervention (up to 8 weeks)

Change in Canadian Occupational Performance Measure (COPM) Satisfaction

Timeframe: Baseline (0 weeks), after intervention (up to 8 weeks)

Change in Spinal Cord Independence Measure (SCIM), Self-care Subscore

Timeframe: Baseline (0 weeks), after intervention (up to 8 weeks)

Change in Capabilities of Upper Extremity Test (CUE-T)

Timeframe: Baseline (0 weeks), after intervention (up to 8 weeks)

Change in Excitability (Active Motor Threshold) of Cortical and Corticospinal Physiology (TMS), Weaker Arm-Biceps

Timeframe: Baseline (0 weeks) and after intervention (up to 8 weeks)

Trial details

NCT IDNCT03892746

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-29

Results submitted2025-10-06

View on ClinicalTrials.gov More Cervical Spinal Cord Injruy trials