A Closed-loop Brain-computer Interface for Stroke

NCT ID: NCT04465786

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-13
• Study Completion Date: 2022-08-31

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.

Conditions

Stroke

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

i-hui Lee, MD, PhD

Role: primary

ihui_lee@hotmail.com

886-2-28712121 ext. 8109

Other Identifiers

2019-08-017B

Identifier Type: -

Identifier Source: org_study_id