A Closed-loop Brain-computer Interface for Stroke

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Recruiting

CT.gov ID

NCT04465786

Collaborator

(none)

Enrollment

Location

25.6

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

70 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

Official Title:

A Closed-loop Brain-computer Interface for Paretic Hand Stimulation After Stroke

Anticipated Study Start Date :

Jul 13, 2020

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Outcome Measures

Primary Outcome Measures

Sensorimotor rhythms [Baseline, during experimental procedures]
electroencephalography

Secondary Outcome Measures

Fugl-Meyer Assessment [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.
Action Research Arm test [At baseline (1-4 week of stroke) and at 3 months after stroke]
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.
Revised Nottingham Sensation Assessment [At baseline (1-4 week of stroke) and at 3 months after stroke]
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.
Motor Activity Log [At baseline (1-4 week of stroke) and at 3 months after stroke]
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.
Resting motor threshold [At baseline (1-4 week of stroke) and at 3 months after stroke]
Transcranial magnetic stimulation test
Motor evoked potential [At baseline (1-4 week of stroke) and at 3 months after stroke]
Transcranial magnetic stimulation test
Resting-state brain connectivity [At baseline (1-4 week of stroke) and at 3 months after stroke]
Magnetic resonance imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Veterans General Hospital	Taipei city		Taiwan	112

Sponsors and Collaborators

Taipei Veterans General Hospital, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taipei Veterans General Hospital, Taiwan

ClinicalTrials.gov Identifier:

NCT04465786

Other Study ID Numbers:

2019-08-017B

First Posted:

Jul 10, 2020

Last Update Posted:

Jul 10, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Taipei Veterans General Hospital, Taiwan

Stroke

Sensorimotor rhyme

Brain-computer interface

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Jul 10, 2020