Brain/Neural Hand Exoskeleton Control for Restoration of Bimanual Tasks

University Hospital Tuebingen

Status

Unknown

Conditions

Stroke

Spinal Cord Injury

Treatments

Device: Brain/neural hand exoskeleton (B/NHE)

Study type

Interventional

Funder types

Other

Identifiers

NCT04440709

NEU007/1

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 68 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)