Brain/Neural Hand Exoskeleton Control for Restoration of Bimanual Tasks

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04440709
• Other study ID #: NEU007/1
• Status: Recruiting
• Phase: N/A
• Start date: June 2020
• Est. completion date: October 2020

Study information

• Verified date: June 2020
• Source: University Hospital Tuebingen
• Contact: Surjo R. Soekadar, MD
• Phone: +49-163-1644889
• Email: surjo.soekadar[@]uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

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)

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Stroke

Intervention

Device:
• Brain/neural hand exoskeleton (B/NHE)
The brain/neural hand exoskeleton restores hand motor function by translating user's intention into grasping motions

Locations

Country	Name	City	State
Germany	Charité - University Medicine Berlin	Berlin
Germany	University Hospital Tuebingen	Tuebingen	BW

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Charite University, Berlin, Germany, Hochschule der Medien, Reutlingen University, University of Stuttgart

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.