A Closed-loop Brain-computer Interface for Stroke

• Conditions: Stroke

• Registration Number: NCT04465786
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study First Submitted: 2020-04-20
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-07
• Last Update Submitted: 2020-07-07
• Study First Posted: 2020-07-10
• Last Update Posted: 2020-07-10
• Study Start: 2020-07-13
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensorimotor rhythms	Baseline, during experimental procedures	electroencephalography

Secondary Outcome Measures

Name	Time	Method
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.
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.
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
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.
Resting-state brain connectivity	At baseline (1-4 week of stroke) and at 3 months after stroke	Magnetic resonance imaging

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei city, Taiwan