Improving SCI Rehabilitation Interventions by Retraining the Brain

  • STATUS
    Recruiting
  • End date
    Sep 29, 2022
  • participants needed
    44
  • sponsor
    The Cleveland Clinic
Updated on 24 January 2021

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 IdentifierNCT03892746
SponsorThe Cleveland Clinic
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have Cervical Spinal Cord Injruy?
Do you have any of these conditions: Do you have Cervical Spinal Cord Injruy??
at least 1 year post injury
weakness of the triceps muscle in the weaker upper limb, defined as a clinically detectable difference in power compared to the power of the spared biceps 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If 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.

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Complete 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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