Poststroke/CVA HemiparesisBCI-strokeNCT02404857
BCI Post-stroke Neurorehabilitation
A study testing EEG based Brain Computer Interface in people with Poststroke/CVA Hemiparesis and Paralytic Stroke, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The goal is to evaluate the potential of a EEG based BCI (Brain-Computer-Interface) connected to a non-invasive pneumatic glove for rehabilitation of hand-movements post-stroke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Poststroke/CVA Hemiparesis, Paralytic Stroke, Hand Flaccid Paralysis
- What is being tested?
- EEG based Brain Computer Interface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Oct 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 6 months post-stroke (chronic), unilateral
- > 18 yrs
- little to no hand movement
- spasticity < 3 on modified Ashworth Scale
Who cannot join
- major cognitive deficits (Folstein mini mental status > 23
- strong hemi-neglect (Catherine Bergego scale > 15/30)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel BCI-controlled Pneumatic Glove System for Neurorehabilitation Post-stroke
The goal is to evaluate the potential of a EEG based BCI (Brain-Computer-Interface) connected to a non-invasive pneumatic glove for rehabilitation of hand-movements post-stroke.
Read the detailed description
Brain computer interfaces (BCI) encompasses the usage of the brain signals to compensate for lost physical function. The current protocol evaluates the therapeutic potential of a EEG based driven BCI that is connected to a non-invasive pneumatic glove for rehabilitation of hand flexion/extension post-stroke. The system non-invasive, portable and low-cost. The utility and usability of the system will be investigated at two levels. First by means of questionnaires for patients and therapist and second by means of in depth analysis of the EEG signals during intended, imagined and passive driven hand movements in relation to no movement at all and the capacity of the BCI to distinguish between these conditions.
- Being tested
- EEG based Brain Computer Interface
- Keywords
- Post stroke, BCI, Reeducation, Hand movement
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG based Brain Computer InterfaceDevice
Using EEG signals to classify brain activity being 'rest' or 'active' to control the attached pneumatic glove and close the sensory-motor loop between intentional/mental movement and physical (though passive) movement.
| Study group | Role | What they receive |
|---|---|---|
| Chronic post-stroke | Experimental | Patients >6 months post-stroke with little to no hand movement. use of EEG based BCI in the neurorehabilitation process Receives: Device: EEG based Brain Computer Interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the BCI-system (evaluation of performance through patient questionaires & the performance of the BCI classifier during intended and imagined hand movements)
Evaluation of the BCI-platform performance through patient questionnaires \& the performance of the BCI classifier during intended and imagined hand movements.
Measured: During the whole study. Assesment is made for each patient after his participation ( 2 hours).
Secondary outcomes (1)
EEG sensory-motor rhythm signals (Detailed analysis of the EEG signals in relation to the severity of the paresis and movement condition)
Detailed analysis of the EEG signals in relation to the severity of the paresis and movement condition
Measured: During the whole studyAssesment is made for each patient after his participation ( 2 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poststroke/CVA HemiparesisStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Université Montpellier, National University of Ireland, Maynooth, Centre Hospitalier Universitaire de Nīmes
- Responsible party
- Sponsor
- Investigators
- Liesjet Van Dokkum, PhD, Principal investigator, CHRU Montpellier, Lapeyronie // Euromov-M2H, Montpellier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404857
- Sponsor's protocol ID
- 9431
- Acronym
- BCI-stroke
- Status last verified
- Nov 2015
- First submitted
- 12 Jan 2015
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel BCI-controlled Pneumatic Glove System for Neurorehabilitation Post-stroke
- ClinicalTrials.gov ID
- NCT02404857
- Acronym / sponsor ID
- BCI-stroke / 9431
- Keywords
- Post stroke, BCI, Reeducation, Hand movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Université Montpellier, National University of Ireland, Maynooth, Centre Hospitalier Universitaire de Nīmes
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 1 Apr 2015 (estimated)
- 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.
The goal is to evaluate the potential of a EEG based BCI (Brain-Computer-Interface) connected to a non-invasive pneumatic glove for rehabilitation of hand-movements post-stroke.
Detailed description
Brain computer interfaces (BCI) encompasses the usage of the brain signals to compensate for lost physical function. The current protocol evaluates the therapeutic potential of a EEG based driven BCI that is connected to a non-invasive pneumatic glove for rehabilitation of hand flexion/extension post-stroke. The system non-invasive, portable and low-cost. The utility and usability of the system will be investigated at two levels. First by means of questionnaires for patients and therapist and second by means of in depth analysis of the EEG signals during intended, imagined and passive driven hand movements in relation to no movement at all and the capacity of the BCI to distinguish between these conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic post-stroke | Experimental | Device: EEG based Brain Computer InterfacePatients >6 months post-stroke with little to no hand movement. use of EEG based BCI in the neurorehabilitation process |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 6 months post-stroke (chronic), unilateral
- > 18 yrs
- little to no hand movement
- spasticity < 3 on modified Ashworth Scale
Key exclusion criteria (2 listed)
- major cognitive deficits (Folstein mini mental status > 23
- strong hemi-neglect (Catherine Bergego scale > 15/30)
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 |
|---|---|---|
| EEG based Brain Computer InterfaceUsing EEG signals to classify brain activity being 'rest' or 'active' to control the attached pneumatic glove and close the sensory-motor loop between intentional/mental movement and physical (though passive) movement. | Device | Chronic post-stroke |
Primary outcome
Performance of the BCI-system (evaluation of performance through patient questionaires & the performance of the BCI classifier during intended and imagined hand movements)
Time frame: During the whole study. Assesment is made for each patient after his participation ( 2 hours).
Evaluation of the BCI-platform performance through patient questionnaires \& the performance of the BCI classifier during intended and imagined hand movements.
1 secondary outcome
EEG sensory-motor rhythm signals (Detailed analysis of the EEG signals in relation to the severity of the paresis and movement condition)
Time frame: During the whole studyAssesment is made for each patient after his participation ( 2 hours).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
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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.
Liesjet Van Dokkum, PhD principal investigator
CHRU Montpellier, Lapeyronie // Euromov-M2H, Montpellier University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG based Brain Computer Interface in people with Poststroke/CVA Hemiparesis and Paralytic Stroke, run by University Hospital, Montpellier at 1 site in France.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 24 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the BCI-system (evaluation of performance through patient questionaires & the performance of the BCI classifier during intended and imagined hand movements) (time frame: During the whole study. Assesment is made for each patient after his participation ( 2 hours).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2015.