Improving SCI Rehabilitation Interventions by Retraining the Brain
Purpose
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
Condition
- Cervical Spinal Cord Injruy
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- In this phase I/II clinical trial, an anticipated 49(up to 54) subjects will receive 15 sessions of upper limb training while receiving either active tDCS or sham tDCS to the target in the brain devoted to the weaker triceps of the weaker upper limb.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Subjects will be randomly assigned by the Cleveland Clinic biostatistician to receive either active or sham tDCS. The tDCS will be pre-programmed with codes for active and sham stimulation. The code will be given to the intervention team by the biostatistician. Investigators analyzing functional outcome data and neurophysiology data will receive coded data that conceals the identity of the subject.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Active tDCS + task oriented practice |
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Sham Comparator Sham tDCS + task oriented practice |
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Recruiting Locations
Cleveland, Ohio 44109
More Details
- Status
- Recruiting
- Sponsor
- The Cleveland Clinic
Detailed Description
This is a phase I/II Multi-site Clinical Trial. In this phase I/II randomized controlled study, 49(up to 54) 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 15 sessions over several weeks up to 8 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.