Spinal Cord Injury, Stroke
Conditions
Brief summary
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.
Interventions
DEVICEBrain/neural hand exoskeleton (B/NHE)
The brain/neural hand exoskeleton restores hand motor function by translating user's intention into grasping motions
Sponsors
Charite University, Berlin, Germany
Reutlingen University
Hochschule der Medien
University of Stuttgart
University Hospital Tuebingen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | 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. |
Countries
Germany
Contacts
Primary ContactSurjo R. Soekadar, MD
Outcome results
None listed