Clinical trial NCT04440709: Brain/Neural Hand Exoskeleton Control for Restoration of Bimanual Tasks
Official title: Restoration of Bimanual Activities of Daily Living Using a Brain/Neural Hand Exoskeleton (B/NHE) in Hand Paralysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injury
Stroke
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: Reutlingen University
name: Hochschule der Medien
name: University of Stuttgart
First posted: 2020-06-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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)

Primary outcomes:
measure: Change in Berlin Bimanual Task Assessment (BEBITA) score
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
state: BW
city: Berlin
country: Germany
facility: Charité - University Medicine Berlin
Study officials:
References: