- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04465786
A Closed-loop Brain-computer Interface for Stroke
July 7, 2020 updated by: Taipei Veterans General Hospital, Taiwan
A Closed-loop Brain-computer Interface for Paretic Hand Stimulation After Stroke
It may be hard to acquire stable sensorimotor rhythm from the affected motor cortex for patient without a response of paretic hand.
A few studies suggest two ways to approaching closed-loop therapy: peripherally extracting the residual signals, for example electromyogram (EMG) at proximal muscles (deltoids) and centrally extracting the activity patterns from unaffected hemisphere during attempting to move paretic hand.
Therefore, understanding neural signatures of residual upper extremity movement among stroke patients might help in discovering potential therapeutic target and developing tailored brain-computer interface (BCI) therapy.
Additionally, 59.4% of stroke patients in acute stage impair at least one somatosensory modality.
It remains unclear whether the patient with somatosensory impairment hinder BCI effect.
Study Overview
Status
Unknown
Conditions
Detailed Description
Investigators will consecutively enroll subacute (1-4 weeks after stroke onset) patients with first-time, unilateral, subcortical stroke and age-matched healthy controls.
All participants will carry on 2 sequential experiments.
In the first experiment, participants will perform 2 motor tasks using either paretic/nondominant upper extremity or non-paretic/dominant upper extremity, called motor attempt (M) condition or calibration condition.
The second experiment contains 3 conditions: cyclic functional electrical stimulation (cFES), cFES during motor attempt (M-cFES), and functional electrical stimulation during brain-computer interface (BCI-FES) in random order.
The sensorimotor oscillations from the electroencephalography (EEG), upper extremity sensorimotor function score (Fugl-Meyer test, Action Research Arm test, and Revised Nottingham Sensation Assessment), corticospinal excitability from the transcranial magnetic stimulation (TMS), and resting-state functional and structural neuroimage from magnetic resonance imaging (MRI) will be assessed before and after the final experiment, as well as 3 months after stroke.
Study Type
Observational
Enrollment (Anticipated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei city, Taiwan, 112
- Recruiting
- Taipei Veterans General Hospital
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Contact:
- i-hui Lee, MD, PhD
- Phone Number: 8109 886-2-28712121
- Email: ihui_lee@hotmail.com
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Principal Investigator:
- i-hui Lee, MD, PhD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Hospitalized participants and healthy controls will be recruited from the Taipei Veterans General Hospital.
Description
Inclusion Criteria:
- first-ever, unilateral infarction or hemorrhage at middle cerebral artery or posterior cerebral artery territory
- early subacute phase of stroke (between 1 and 4 weeks after stroke onset)
Exclusion Criteria:
- electroencephagraphy feature is not usable
- Fugl-Meyer Assessment of Upper Extremity score is over 50
- ataxia
- global aphasia
- concomitant neurological diseases
- psychiatric diseases
- participating in other interventional research during this period
- other conditions might interfere with experiment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensorimotor rhythms
Time Frame: Baseline, during experimental procedures
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electroencephalography
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Baseline, during experimental procedures
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fugl-Meyer Assessment
Time Frame: At baseline (1-4 week of stroke) and at 3 months after stroke
|
Fugl-Meyer Assessment (FMA) measures both upper-limb and lower-limb motor function.
The total score of FMA ranges from 0 to 100, which higher score indicates better motor recovery.
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At baseline (1-4 week of stroke) and at 3 months after stroke
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Action Research Arm test
Time Frame: At baseline (1-4 week of stroke) and at 3 months after stroke
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Action Research Arm test (ARAT) measures specific upper-limb and hand function.
The total score of ARAT ranges from 0 to 57, which higher score indicates better motor function.
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At baseline (1-4 week of stroke) and at 3 months after stroke
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Revised Nottingham Sensation Assessment
Time Frame: At baseline (1-4 week of stroke) and at 3 months after stroke
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Revised Nottingham Sensation Assessment (rNSA) measures various upper-limb sensory function.
The total score of rNSA ranges from 0 to 151, which higher score indicates better somatosensory function.
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At baseline (1-4 week of stroke) and at 3 months after stroke
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Motor Activity Log
Time Frame: At baseline (1-4 week of stroke) and at 3 months after stroke
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Motor Activity Log (MAL) measures real-use of upper-limb.
The averaged index of MAL ranges from 0 to 5, which higher index indicates more frequently use of paretic upper limb.
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At baseline (1-4 week of stroke) and at 3 months after stroke
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Resting motor threshold
Time Frame: At baseline (1-4 week of stroke) and at 3 months after stroke
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Transcranial magnetic stimulation test
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At baseline (1-4 week of stroke) and at 3 months after stroke
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Motor evoked potential
Time Frame: At baseline (1-4 week of stroke) and at 3 months after stroke
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Transcranial magnetic stimulation test
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At baseline (1-4 week of stroke) and at 3 months after stroke
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Resting-state brain connectivity
Time Frame: At baseline (1-4 week of stroke) and at 3 months after stroke
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Magnetic resonance imaging
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At baseline (1-4 week of stroke) and at 3 months after stroke
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 13, 2020
Primary Completion (Anticipated)
August 31, 2022
Study Completion (Anticipated)
August 31, 2022
Study Registration Dates
First Submitted
April 20, 2020
First Submitted That Met QC Criteria
July 7, 2020
First Posted (Actual)
July 10, 2020
Study Record Updates
Last Update Posted (Actual)
July 10, 2020
Last Update Submitted That Met QC Criteria
July 7, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-08-017B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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