A Telerehabilitation Program for SCI

Study Overview
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Brief Summary
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This study evaluates a remotely supervised, home-based therapeutic program to improve upper-limb voluntary movement in adults with tetraplegia caused by incomplete spinal cord injury (iSCI).

Detailed Description
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Spinal Cord Injury (SCI) has been associated with serious reduction in functional independence. Despite compelling evidence that treatment intensity has a profound effect on motor recovery only a small fraction of SCI population are able to receive intensive in-clinic treatment. Difficulty traveling to the clinic, poor adherence to assignments and high cost are limiting factors. Currently, telerehabilitation programs are emerging as an alternative effective method of delivery for rehabilitation services. The literature and our preliminary findings support the model that augmentation of activity in spared corticospinal tract (CST) axons is a critical mechanism of motor improvement, and furthermore that CST activity can be increased by repetitive motor training and by electrical stimulation of the primary motor cortex (M1). However, there is still lack of knowledge on safety, feasibility and efficacy of remotely- supervised home-based therapy programs that incorporates non-invasive brain stimulation and high intensity repetitive arm exercises. To address these questions, 36 adults (above 18 years) with cervical SCI will be randomly assigned to two groups in a 2:1 ratio (active stimulation group, n=24 vs control group, n=12) and receive daily treatment, 10 sessions, over 2-weeks. The anodal tDCS will be applied over primary motor cortex (M1) at an intensity of 2mA for 20 minutes and proceed with 60 minutes of repetitive arm and hand training. Primary outcome measure is change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) from baseline to immediately after treatment and 4-weeks follow-up. The session will be supervised in real-time via videoconferencing.

Official Title
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Feasibility and Effectiveness of Home-based Telerehabilitation Program for Recovery of Upper Limb Functions in Incomplete Spinal Cord Injury

Conditions
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Incomplete Spinal Cord Injury

Intervention / Treatment
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* Device: Active tDCS
* Device: Sham tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of a chronic incomplete cervical lesion as defined by the American Spinal Injury Association Impairment scale classification and at least for 6 months post-injury; upper-extremity weakness associated with tetraplegia with minimal residual thumb and index; finger movement sufficient to grip small objects such as marble; no brain injury; no planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study; no contradiction to tDCS; access to internet at home. Exclusion Criteria: prior history of seizure; chronic use of neuroactive medication (e.g., neurostimulants, anticonvulsants, or antidepressants); any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score ≥ than 3 out of 4.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double-blind, randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS<br>Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes | Device: Active tDCS<br>* Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.<br>|
| Sham Comparator: Sham tDCS<br>Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes | Device: Sham tDCS<br>* Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | This is a multi-modality test designed to assess the integration of sensorimotor hand and upper limb impairment and function. This test combines the features of several other tests that have been used to assess hand and upper limb function in the peripheral hand population | Change from baseline at 2 weeks and at 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence with the therapy | Number of sessions attended | Treatment Day 1- Day 10 | 
| Adherence with the therapy | Number of drop-outs | Between enrollment and 1-month follow-up | 
| Feasibility of home intervention | Participants perception in usefulness of intervention on a scale from 0-10. Higher numbers reflecting higher usability. | Change from baseline at 2 weeks and at 1 month | 
| Grip Strength | Maximum force generated by hand muscles and measured with a hand-held dynamometer | Change from baseline at 2 weeks and at 1 month | 
| Spinal Cord Injury Independence Measure (SCIM III)-Self Care | Assessment of achievements of self care, score ranges between 0 to 20 with higher numbers reflecting higher level of independence in daily functions | Change from baseline at 2 weeks and at 1 month | 
| Incidence of adverse events | Collection of adverse events during the treatment period. | From treatment day1 to treatment day10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Spinal Cord Injury, upper limb, tDCS, telerehabilitation