Brain/Neural Hand Exoskeleton Control for Restoration of Bimanual Tasks

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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Spinal Cord Injury
• Intervention / Treatment: Device: Brain/neural hand exoskeleton (B/NHE)

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité - University Medicine Berlin
    • Contact: Surjo R Soekadar, MD; Phone Number: +49 30 450 528 153; Email: surjo.soekadar@charite.de
  • BW
    • Tuebingen, BW, Germany, 72076
      • Recruiting
      • University Hospital Tuebingen
      • Contact: Surjo R. Soekadar, MD; Phone Number: +49-163-1644889; Email: surjo.soekadar@uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: Charite University, Berlin, Germany; University of Stuttgart; Reutlingen University; Hochschule der Medien

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: NEU007/1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No