Brain/Neural Hand Exoskeleton Control for Restoration of... | NCT04440709

Studies
Brain/Neural Hand Exoskeleton Control for Restoration of Bimanual Tasks

NCT04440709

Sponsor

University Hospital Tuebingen

Status

Unknown status

Last Update Posted

Jun 22, 2020Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Spinal Cord Injury
Stroke

Interventions

Brain/neural hand exoskeleton (B/NHE)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2020Estimated

Primary Completion Date

Jul 2020Estimated

Completion Date

Oct 2020Estimated

First Submitted Date

Jun 18, 2020

First Submission Date that Met QC Criteria

Jun 18, 2020

First Posted Date

Jun 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2020

Last Update Posted Date

Jun 22, 2020Actual

Name	Class
Charite University, Berlin, Germany	OTHER
Reutlingen University	UNKNOWN
Hochschule der Medien	UNKNOWN
University of Stuttgart

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Label	Type	Description	Intervention Names
Brain/neural hand exoskeleton (B/NHE)	Experimental		Device: Brain/neural hand exoskeleton (B/NHE)

Name	Type	Description	Arm Group Labels	Other Names
Brain/neural hand exoskeleton (B/NHE)	Device	The brain/neural hand exoskeleton restores hand motor function by translating user's intention into grasping motions	Brain/neural hand exoskeleton (B/NHE)

Measure	Description	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.

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

68 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Surjo R. Soekadar, MD	Contact	+49-163-1644889		surjo.soekadar@uni-tuebingen.de

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Tuebingen	Recruiting	Tübingen	Baden-Wurttemberg	72076	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41361479	Derived	Vermehren M, Colucci A, Angerhofer C, Peekhaus N, Kim WS, Chang WK, Kim H, Homberg V, Paik NJ, Soekadar SR. The Berlin bimanual test for stroke survivors (BeBiT-S): evaluating exoskeleton-assisted bimanual motor function after stroke. J Neuroeng Rehabil. 2025 Dec 8;22(1):261. doi: 10.1186/s12984-025-01822-6.

ID	Term
D013119	Spinal Cord Injuries
D020521	Stroke

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System