Robotic Therapy and Brain Stimulation in the Early Phase After Stroke

Study Overview
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Brief Summary
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Stroke is the second cause of death worldwide and the majority of the survivors remain with motor impairments. Inhibition of the motor cortex of the unaffected hemisphere has emerged as a potential intervention to enhance effects of other rehabilitation strategies on improvement of motor performance of the paretic upper limb. In this proof-of-concept study we will evaluate the effects of inhibition of the motor cortex of the unaffected hemisphere associated with robotic therapy on improvement of motor performance of the paretic upper limb in the early phase post-stroke.

Detailed Description
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The main goal of this study is to test the proof of concept of benefits of inhibition of the motor cortex of the unaffected hemisphere on learning evaluated by improvement in kinematics of motor performance, in patients with upper limb paresis in the early phase post-stroke. For this purpose, patients will be randomized to receive real or sham transcranial direct current stimulation before a session of robotic therapy. Data will be collected by kinematic assessment performed automatically by the robot at baseline, immediately after and 24h after the intervention. The working hypothesis is that one session of upper limb motor training will lead to improvement of performance in metrics of kinematics, and this improvement will be maintained up to 24h after the end of the training.

Official Title
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Effects of Robotic Therapy and Transcranial Direct Current Stimulation on Motor Performance of the Paretic Upper Limb in the Early Phase After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: Robotic Therapy
* Device: Active stimulation
* Device: Sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic or hemorrhagic stroke onset from 3 days to 9 weeks before, confirmed by computed tomography or magnetic resonance imaging. Motor impairment of an upper limb, defined as a score between 1 - 3 in the Medical Research Council Scale, for at lest one the following movements: elbow extension, shoulder flexion, or shoulder extension. Ability to provide written informed consent. Ability to comply with the schedule of interventions and evaluations in the protocol. Exclusion Criteria: Severe spasticity at the paretic elbow, wrist or fingers, defined as a score of > 3 in the Modified Ashworth Spasticity Scale. No active shoulder and elbow movements Uncontrolled medical problems such as end-stage cancer or renal disease Pregnancy Potential contraindications to transcranial direct current stimulation: history of seizures, lesions on the scalp, intracranial metal implants, prior intracranial surgery, use of drugs that interfere on cortical excitability (such as antiepileptic drugs, benzodiazepines) Other neurological disorders such as Parkinson's disease Psychiatric illness Aphasia or severe cognitive deficits that compromise comprehension of the experimental protocol or ability to provide consent. Hemineglect Cerebellar lesions or on cerebellar pathways Contact precautions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active stimulation + robotic therapy<br>Active transcranial direct current stimulation will be applied during 20 minutes prior to robotic training. Number of interventions sessions: 1 | Device: Robotic Therapy<br>* Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.<br>Device: Active stimulation<br>* Active transcranial direct current stimulation will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).<br>|
| Sham Comparator: Sham stimulation + robotic therapy<br>Sham transcranial direct current stimulation will be applied during 20 minutes prior to robotic training. Number of interventions sessions: 1 | Device: Robotic Therapy<br>* Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.<br>Device: Sham stimulation<br>* In sham transcranial direct current stimulation, no current will be delivered through the transcranial direct current stimulation device after the first 30 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement Smoothness | The speed shape, calculated as mean speed divided by peak speed. | Kinematic assessment at baseline, immediately after intervention; and 24h after. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of peaks of the movement | Number of peaks of the movement is calculated as the negative of the number of peaks in the speed profile. | kinematic assessment at baseline, immediately after intervention; and 24h after. | 
| Jerk metric of the movement | Jerk metric of the movement is calculated by dividing the negative mean jerk magnitude by the peak speed. | kinematic assessment at baseline, immediately after intervention; and 24h after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial direct current stimulation, stroke, robotic therapy