Improving SCI Rehabilitation Interventions by Retraining the Brain

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Cervical Spinal Cord Injruy

In brief

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

Key facts

Study ID

NCT03892746

Run by

The Cleveland Clinic

People needed

47

Starts

2019-07-12

Expected to finish

2024-10-09

Last updated by the study team

2025-12-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Kessler Foundation — West Orange, New Jersey, United States
• Louis B. Stokes Cleveland VA Medical Center — Cleveland, Ohio, United States
• The MetroHealth System — Cleveland, Ohio, United States
• Lerner Research Institute; Cleveland Clinid Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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