Improving SCI Rehabilitation Interventions by Retraining the Brain

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Improving SCI Rehabilitation Interventions by Retraining the Brain

Conditions
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Cervical Spinal Cord Injruy

Intervention / Treatment
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* Device: Active tDCS + task oriented practice
* Device: Sham tDCS + task oriented practice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active tDCS + task oriented practice<br> | Device: Active tDCS + task oriented practice<br>* Participants in this arm will receive active tDCS(2mA) to the motor cortex(targeting the triceps) of the weaker upper limb for 2 30 minute cycles during each 2 hour upper limb training session. While receiving tDCS the participant will be performing task oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.<br>|
| Sham Comparator: Sham tDCS + task oriented practice<br> | Device: Sham tDCS + task oriented practice<br>* Participants in this arm will receive sham tDCS(0mA) to the motor cortex(targeting the triceps) of the weaker upper limb for 2 30 minute cycles during each 2 hour upper limb training session. While receiving tDCS the participant will be performing task oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Upper Extremity Motor Score(UEMS) with Manual Muscle Testing | UEMS is used in Spinal Cord injury to identify strength(muscle power) in patients with spinal cord injury. | Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up. | 
| Change in GRASSP | GRASSP is a functional measure which identifies the functional ability of the upper limbs and is widely used in studies recruiting Spinal Cord Injury patients | Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up. | 
| Change in Canadian Occupational Performance Measure (COPM) | COPM is used to measure participation restrictions of Spinal Cord Injury Subjects | Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up. | 
| Change in Spinal Cord Independence Measure(SCIM) | SCIM is a spinal cord injury measure that identifies activity limitations of self-care | Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up. | 
| Change in excitability of cortical and corticospinal physiology (TMS) | Transcranial magnetic stimulation will be used to test cortical and corticospinal physiology. The threshold of the biceps and triceps of the weaker upper limb will be collected. Motor maps dedicated to the biceps and triceps of the weaker upper limb will be collected. These motor maps will show the area and strength of neuronal control to the biceps and triceps of the weaker upper limb. | Baseline (0 weeks and 3 weeks) and after intervention(up to 8 weeks) | 
| Change in excitability of spinal physiology (H-reflex) | Spinal pathways will be tested using peripheral nerve testing. During this testing H-reflex will be collected. | Baseline (0 weeks and 3 weeks) and after intervention(up to 8 weeks) | 
| Change in Capabilities of Upper Extremity Test(CUE-T) | CUE-T is a functional measure which identifies the functional ability of the upper limbs and is widely used in studies recruiting Spinal Cord Injury patients | Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Spinal Cord Injury, tDCS, Transcranial Direct Current Stimulation, Upper limb, Rehabilitation, Brain Stimulation