Brain/Neural Hand Exoskeleton Control for Restoration of Bimanual Tasks

NCT ID: NCT04440709

Last Updated: 2020-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2020-10-31

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.

Conditions

Spinal Cord Injury; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Brain/neural hand exoskeleton (B/NHE)

Group Type: EXPERIMENTAL

Brain/neural hand exoskeleton (B/NHE)

Intervention Type: DEVICE

The brain/neural hand exoskeleton restores hand motor function by translating user's intention into grasping motions

Interventions

Brain/neural hand exoskeleton (B/NHE)

The brain/neural hand exoskeleton restores hand motor function by translating user's intention into grasping motions

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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"

• 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

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

Reutlingen University

UNKNOWN

Sponsor Role: collaborator

Hochschule der Medien

UNKNOWN

Sponsor Role: collaborator

University of Stuttgart

OTHER

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Charité - University Medicine Berlin

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Surjo R. Soekadar, MD

Role: CONTACT

surjo.soekadar@uni-tuebingen.de

+49-163-1644889

Facility Contacts

Surjo R. Soekadar, MD

Role: primary

surjo.soekadar@uni-tuebingen.de

+49-163-1644889

Surjo R Soekadar, MD

Role: primary

surjo.soekadar@charite.de

+49 30 450 528 153

Other Identifiers

NEU007/1

Identifier Type: -

Identifier Source: org_study_id