BCI Post-stroke Neurorehabilitation
BCI-stroke
A Novel BCI-controlled Pneumatic Glove System for Neurorehabilitation Post-stroke
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 12, 2015
CompletedFirst Posted
Study publicly available on registry
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedNovember 24, 2015
November 1, 2015
9 months
January 12, 2015
November 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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)
During the whole studyAssesment is made for each patient after his participation ( 2 hours).
Study Arms (1)
Chronic post-stroke
EXPERIMENTALPatients \>6 months post-stroke with little to no hand movement. use of EEG based BCI in the neurorehabilitation process
Interventions
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.
Eligibility Criteria
You may qualify if:
- \> 6 months post-stroke (chronic), unilateral
- \> 18 yrs
- little to no hand movement
- spasticity \< 3 on modified Ashworth Scale
You may not qualify if:
- major cognitive deficits (Folstein mini mental status \> 23
- strong hemi-neglect (Catherine Bergego scale \> 15/30)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Montpellierlead
- Université Montpelliercollaborator
- National University of Ireland, Maynoothcollaborator
- Centre Hospitalier Universitaire de Nīmescollaborator
Study Sites (1)
CHRU Lapeyronie
Montpellier, Herault, 34295, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liesjet Van Dokkum, PhD
CHRU Montpellier, Lapeyronie // Euromov-M2H, Montpellier University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2015
First Posted
April 1, 2015
Study Start
January 1, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
November 24, 2015
Record last verified: 2015-11