Spinal Cord InjuryNCT04440709
Brain/Neural Hand Exoskeleton Control for Restoration of Bimanual Tasks
A study testing Brain/neural hand exoskeleton (B/NHE) in people with Spinal Cord Injury and Stroke, run by University Hospital Tuebingen at 2 sites in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Spinal Cord Injury, Stroke
- What is being tested?
- Brain/neural hand exoskeleton (B/NHE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesGermany
- Study dates
- Jun 2020to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 16Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Charité - University Medicine Berlin
Berlin, 10117
Surjo R Soekadar, MD, +49 30 450 528 153, surjo.soekadar@charite.de
- Recruiting
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076
Surjo R. Soekadar, MD, +49-163-1644889, surjo.soekadar@uni-tuebingen.de
About this study
Official title: 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.
- Conditions
- Spinal Cord Injury, Stroke
- Being tested
- Brain/neural hand exoskeleton (B/NHE)
- Medical subject headings
- Spinal Cord Injuries, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain/neural hand exoskeleton (B/NHE)Device
The brain/neural hand exoskeleton restores hand motor function by translating user's intention into grasping motions
| Study group | Role | What they receive |
|---|---|---|
| Brain/neural hand exoskeleton (B/NHE) | Experimental | Not described Receives: Device: Brain/neural hand exoskeleton (B/NHE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Berlin Bimanual Task Assessment (BEBITA) score
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study startJun 2020 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Reutlingen University, Hochschule der Medien, University of Stuttgart
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440709
- Sponsor's protocol ID
- NEU007/1
- Status last verified
- Jun 2020
- First submitted
- 18 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41361479
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Bimanual Activities of Daily Living Using a Brain/Neural Hand Exoskeleton (B/NHE) in Hand Paralysis
- ClinicalTrials.gov ID
- NCT04440709
- Acronym / sponsor ID
- NEU007/1
- Conditions
- Spinal Cord Injury, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Reutlingen University, Hochschule der Medien, University of Stuttgart
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain/neural hand exoskeleton (B/NHE) | Experimental | Device: Brain/neural hand exoskeleton (B/NHE) |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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"
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain/neural hand exoskeleton (B/NHE)The brain/neural hand exoskeleton restores hand motor function by translating user's intention into grasping motions | Device | Brain/neural hand exoskeleton (B/NHE) |
Primary outcome
Change in Berlin Bimanual Task Assessment (BEBITA) score
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Derived from this study: PubMed 41361479Vermehren 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain/neural hand exoskeleton (B/NHE) in people with Spinal Cord Injury and Stroke, run by University Hospital Tuebingen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Surjo R. Soekadar, MD (+49-163-1644889, surjo.soekadar@uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Berlin Bimanual Task Assessment (BEBITA) score (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04440709, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.