A Closed-loop Brain-computer Interface for Stroke

Study Overview
=================
Brief Summary
-----------------
It may be hard to acquire stable sensorimotor rhythm from the affected motor cortex for patient without a response of paretic hand. A few studies suggest two ways to approaching closed-loop therapy: peripherally extracting the residual signals, for example electromyogram (EMG) at proximal muscles (deltoids) and centrally extracting the activity patterns from unaffected hemisphere during attempting to move paretic hand. Therefore, understanding neural signatures of residual upper extremity movement among stroke patients might help in discovering potential therapeutic target and developing tailored brain-computer interface (BCI) therapy. Additionally, 59.4% of stroke patients in acute stage impair at least one somatosensory modality. It remains unclear whether the patient with somatosensory impairment hinder BCI effect.

Detailed Description
-----------------
Investigators will consecutively enroll subacute (1-4 weeks after stroke onset) patients with first-time, unilateral, subcortical stroke and age-matched healthy controls. All participants will carry on 2 sequential experiments. In the first experiment, participants will perform 2 motor tasks using either paretic/nondominant upper extremity or non-paretic/dominant upper extremity, called motor attempt (M) condition or calibration condition. The second experiment contains 3 conditions: cyclic functional electrical stimulation (cFES), cFES during motor attempt (M-cFES), and functional electrical stimulation during brain-computer interface (BCI-FES) in random order. The sensorimotor oscillations from the electroencephalography (EEG), upper extremity sensorimotor function score (Fugl-Meyer test, Action Research Arm test, and Revised Nottingham Sensation Assessment), corticospinal excitability from the transcranial magnetic stimulation (TMS), and resting-state functional and structural neuroimage from magnetic resonance imaging (MRI) will be assessed before and after the final experiment, as well as 3 months after stroke.

Official Title
-----------------
A Closed-loop Brain-computer Interface for Paretic Hand Stimulation After Stroke

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first-ever, unilateral infarction or hemorrhage at middle cerebral artery or posterior cerebral artery territory early subacute phase of stroke (between 1 and 4 weeks after stroke onset) Exclusion Criteria: electroencephagraphy feature is not usable Fugl-Meyer Assessment of Upper Extremity score is over 50 ataxia global aphasia concomitant neurological diseases psychiatric diseases participating in other interventional research during this period other conditions might interfere with experiment

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensorimotor rhythms | electroencephalography | Baseline, during experimental procedures | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment | Fugl-Meyer Assessment (FMA) measures both upper-limb and lower-limb motor function. The total score of FMA ranges from 0 to 100, which higher score indicates better motor recovery. | At baseline (1-4 week of stroke) and at 3 months after stroke | 
| Action Research Arm test | Action Research Arm test (ARAT) measures specific upper-limb and hand function. The total score of ARAT ranges from 0 to 57, which higher score indicates better motor function. | At baseline (1-4 week of stroke) and at 3 months after stroke | 
| Revised Nottingham Sensation Assessment | Revised Nottingham Sensation Assessment (rNSA) measures various upper-limb sensory function. The total score of rNSA ranges from 0 to 151, which higher score indicates better somatosensory function. | At baseline (1-4 week of stroke) and at 3 months after stroke | 
| Motor Activity Log | Motor Activity Log (MAL) measures real-use of upper-limb. The averaged index of MAL ranges from 0 to 5, which higher index indicates more frequently use of paretic upper limb. | At baseline (1-4 week of stroke) and at 3 months after stroke | 
| Resting motor threshold | Transcranial magnetic stimulation test | At baseline (1-4 week of stroke) and at 3 months after stroke | 
| Motor evoked potential | Transcranial magnetic stimulation test | At baseline (1-4 week of stroke) and at 3 months after stroke | 
| Resting-state brain connectivity | Magnetic resonance imaging | At baseline (1-4 week of stroke) and at 3 months after stroke | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Sensorimotor rhyme, Brain-computer interface