Brain/Neural Hand Exoskeleton Control for Restoration of Bimanual Tasks

Study Overview
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Brief Summary
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This study investigates whether spinal cord injury and stroke survivors (n=10) are able to operate a brain/neural hand exoskeleton (B/NHE) based on electroencephalography (EEG) and electrooculography (EOG) for restoration of bimanual activities of daily living (ADLs). To assess bimanual ADLs, the Berlin Bimanual Task Assessment (BEBITA) will be applied. Improvements in BEBITA will be evaluated with and without B/NHE use.

Official Title
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Restoration of Bimanual Activities of Daily Living Using a Brain/Neural Hand Exoskeleton (B/NHE) in Hand Paralysis

Conditions
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Spinal Cord Injury, Stroke

Intervention / Treatment
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* Device: Brain/neural hand exoskeleton (B/NHE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Stroke): single ischemic or hemorrhagic insult with subcortical lesion (medullary canal, internal capsula, pedunculi cerebri) interval since stroke at least 6 months substantial motor deficit with: Medical Research Council (MRC) -score of less than 2 out of 6 possible points (0=no activity; 1=visible contraction without motor effect; 2=movements with elimination of gravity; 3=movements against gravity; 4=movements against weak resistance; 5=normal force) Fugl-Meyer Test (upper extremity) of less than 31 points, no to little mobility Inclusion Criteria (Spinal Cord Injury): cervical spinal cord injury, height C5-C6 interval after spinal cord injury at least 6 months substantial motor deficit with American Spinal Cord Association (ASIA) -Classification B or C (A=no muscle function/sensitivity below the spinal cord injury; B=no muscle function, limited sensitivity present; C=low non-relevant muscle function, sensitivity present; D=functionally relevant muscle functions present; E=fully preserved or restored functions) Exclusion Criteria (Stroke and Spinal Cord Injury): Alcohol or drug problem (regular consumption of more than 2 alcoholic beverages per day, or taking illegal drugs) currently undergoing neurological or psychiatric treatment based on a secondary diagnosis Severe and uncontrollable medical problems: Non-adjusted malignant high blood pressure, World Health Organization (WHO) Hypertension Grade II non-adjustable diabetes mellitus, HbA1c > 58 mmol/mol renal failure, from KDIGO glomerular filtration rate (GFR) category G3b (moderate to severe impairment) Liver failure, Child-Pugh stages B and C Heart failure New York Heart Association (NYHA) grade III-IV malignant tumor disease severe arrhythmia in need of treatment severe oedemas severe arthritis serious cognitive impairment (minimum status below 23 points) Severe spasticity (Ashworth grade ≥ 4) Pregnancy Bilateral motor deficit (in stroke patients)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain/neural hand exoskeleton (B/NHE)<br> | Device: Brain/neural hand exoskeleton (B/NHE)<br>* The brain/neural hand exoskeleton restores hand motor function by translating user's intention into grasping motions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Berlin Bimanual Task Assessment (BEBITA) score |  | Hand function will be assessed twice on the same day. Once before the hand exoskeleton is applied (absence of the assistive device) and once after the brain-controlled hand exoskeleton was attached to the patients' hand and arm. |