Improving SCI Rehabilitation Interventions by Retraining the Brain
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- STATUS
- Recruiting
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- End date
- Sep 29, 2022
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- participants needed
- 44
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- sponsor
- The Cleveland Clinic
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 visits over a period of 3 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
Description
This is a phase I/II Multi-site Clinical Trial. In this phase I/II randomized controlled study, 18 cervical spinal patients with upper limb impairments will receive non-invasive brain stimulation tDCS (Transcranial Direct Current Stimulation) to the area in the brain controlling the weaker muscle of the weakest upper limb while receiving training for 5 days a weeks for 3 weeks. The primary outcome will be motor limb impairment, and secondary outcomes will be tests of functional ability, spinal excitability, and strength and dexterity. Safety and feasibility of pairing tDCS with rehabilitation will also be explored and include adverse effects, subject/investigator blinding, and attrition to 3 month follow-up.
Details
| Condition | Cervical Spinal Cord Injruy |
|---|---|
| Treatment | Active tDCS + task oriented practice, Sham tDCS + task oriented practice |
| Clinical Study Identifier | NCT03892746 |
| Sponsor | The Cleveland Clinic |
| Last Modified on | 24 January 2021 |
How to participate?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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