A Closed-loop Brain-computer Interface for Stroke

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: 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 Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• Taiwan
  • Taipei city, Taiwan, 112
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: i-hui Lee, MD, PhD; Phone Number: 8109 886-2-28712121; Email: ihui_lee@hotmail.com
    • Principal Investigator: i-hui Lee, MD, PhD

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensorimotor rhythms	electroencephalography	Baseline, during experimental procedures

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

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

• Keywords: Stroke; Brain-computer interface; Sensorimotor rhyme
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• 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