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A Closed-loop Brain-computer Interface for Stroke

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04465786
Enrollment
70
Registered
2020-07-10
Start date
2020-07-13
Completion date
2022-08-31
Last updated
2020-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Sensorimotor rhyme, Brain-computer interface

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.

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.

Interventions

None listed

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Sensorimotor rhythmsBaseline, during experimental procedureselectroencephalography

Secondary

MeasureTime frameDescription
Action Research Arm testAt baseline (1-4 week of stroke) and at 3 months after strokeAction 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 AssessmentAt baseline (1-4 week of stroke) and at 3 months after strokeRevised 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 LogAt baseline (1-4 week of stroke) and at 3 months after strokeMotor 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.
Fugl-Meyer AssessmentAt baseline (1-4 week of stroke) and at 3 months after strokeFugl-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.
Motor evoked potentialAt baseline (1-4 week of stroke) and at 3 months after strokeTranscranial magnetic stimulation test
Resting-state brain connectivityAt baseline (1-4 week of stroke) and at 3 months after strokeMagnetic resonance imaging
Resting motor thresholdAt baseline (1-4 week of stroke) and at 3 months after strokeTranscranial magnetic stimulation test

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026