NCT04440709

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

1 month

First QC Date

June 18, 2020

Last Update Submit

June 18, 2020

Conditions

Spinal Cord InjuryStroke

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Brain/neural hand exoskeleton (B/NHE)

EXPERIMENTAL
Device: Brain/neural hand exoskeleton (B/NHE)

Interventions

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)

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Charité - University Medicine Berlin

Berlin, 10117, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41361479DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesStroke

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersBrain DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Surjo R. Soekadar, MD

CONTACT

+49-163-1644889surjo.soekadar@uni-tuebingen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 22, 2020

Study Start

June 1, 2020

Primary Completion

July 1, 2020

Study Completion

October 1, 2020

Last Updated

June 22, 2020

Record last verified: 2020-06

Locations

DE(2)