A Closed-loop Brain-computer Interface for Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04465786
• Other study ID #: 2019-08-017B
• Status: Recruiting
• Start date: July 13, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: July 2020
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei city

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensorimotor rhythms	electroencephalography	Baseline, during experimental procedures
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Resting motor threshold	Transcranial magnetic stimulation test	At baseline (1-4 week of stroke) and at 3 months after stroke
Secondary	Motor evoked potential	Transcranial magnetic stimulation test	At baseline (1-4 week of stroke) and at 3 months after stroke
Secondary	Resting-state brain connectivity	Magnetic resonance imaging	At baseline (1-4 week of stroke) and at 3 months after stroke