Validation of a Brain-Computer Interface for Stroke Neurological Upper Limb Rehabilitation

Study Overview
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Brief Summary
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The study's main goal is to determine if clinical and physiological effects of a brain-computer interface intervention for the neurorehabilitation of stroke patients' upper limb are greater than the effects of a sham robotic feedback. For this purpose a randomized controlled trial will be performed to compare somatosensory sham robotic feedback with the same somatosensory feedback controlled with the brain-computer interface output.

Official Title
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Validation of a Brain-Computer Interface for Neurorehabilitation With a Randomized Controlled Trial (Validación de Una Interfaz Cerebro-Computadora Para Rehabilitación Neurológica Por Medio de un Ensayo Clínico Controlado y Aleatorizado)

Conditions
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Stroke, Ischemic, Stroke

Intervention / Treatment
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* Device: Brain-Computer Interface
* Device: Sham Brain-Computer Interface


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of first ischemic stroke Time since stroke onset higher than 3 months and lower than 24 months Hand paresis Normal or corrected to normal vision Without previous diagnosed neurological diseases Exclusion Criteria: Clinical diagnosis of severe aphasia Clinical diagnosis of severe depression Clinical diagnosis of severe attention deficits Previous diagnosis of traumatic brain injury Previous diagnosis of spinal cord injury Previous diagnosis of peripheral nerve injury

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain-Computer Interface controlled robotic feedback<br> | Device: Brain-Computer Interface<br>* Passive hand movement will be provided to patients' paralyzed hand by means of a robotic hand orthosis that will be activated by the brain-computer interface based on hand movement intention.<br>|
| Sham Comparator: Sham Brain-Computer Interface controlled robotic feedback<br> | Device: Sham Brain-Computer Interface<br>* Passive hand movement will be provided to patients' paralyzed hand by means of a robotic hand orthosis which activation will be independent of the output of the brain-computer interface based on hand movement intention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in upper limb motor function on the Fugl-Meyer Assessment for the Upper Extremity | Analysis of changes on the Fugl-Meyer Assessment for the Upper Extremity will reveal if there is a clinical significant sensorimotor function compared to baseline | At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset | 
| Mean change from baseline in upper limb motor function on the Action Research Arm Test | Analysis of changes on the Action Research Arm Test will reveal if there is a clinical significant motor function compared to baseline | At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in cortical activity measured with Functional Magnetic Resonance Imaging | Blood-oxygen-level-dependent imaging will be analyzed to assess if there are changes in cortical activity compared to baseline. | At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset | 
| Mean change from baseline in corticospinal excitability measured with Transcranial Magnetic Stimulation | Motor Evoked Potentials parameters will reveal if there are changes of corticospinal excitability in both hemibodies compared to baseline | At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset | 
| Mean change from baseline in grip strength measured with a dynamometer | Analysis of hand strength measurements will reveal if there were changes compared to baseline | At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain-computer interface, robotic orthosis, hemiparesis, motor rehabilitation