EEG Based BCI for Upper Limb Rehabilitation in Stroke

Not Applicable

• Conditions: Stroke Sequelae; Brain Ischemia
• Interventions: Other: EEG -BCI based Feedback for rehabilitation

• Registration Number: NCT04188132
• Lead Sponsor: University of Houston

Brief Summary

Biomedical and Engineering approaches form a key element to neurological rehabilitation of upper limbs. Brain Computer Interface (BCI) using Motor execution and Motor Imagery are known to aid motor recovery in stroke. The purpose of this study is to demonstrate that Noninvasive Sensorimotor Rhythm (SMR) based EEG based BCI using motor execution and Motor Imagery tasks can aid in rehabilitation of upper limb movements in chronic stroke.

The project aims to explore an SMR-based BCI system that can exploit the sensorimotor rhythm voluntary modulation to play a virtual game as neurofeedback using motor executory tasks and imagined hand movements by stroke patients, who suffer from upper limb disability.

Detailed Description

Brain Computer Interface (BCI) using Motor execution and Motor Imagery are known to aid motor recovery in stroke. The purpose of this study is to demonstrate that Noninvasive Sensorimotor Rhythm (SMR) based EEG based BCI using motor execution and Motor Imagery tasks can aid in rehabilitation of upper limb movements in chronic stroke.

The project aims to explore an SMR-based BCI system that can exploit the sensorimotor rhythm voluntary modulation to play a virtual game as neurofeedback using motor executory tasks and imagined hand movements by stroke patients, who suffer from upper limb disability. Studies have shown that movement and motor imagery (MI) (i.e., the mental rehearsal of a movement without any activation of the muscles) induce similar EEG patterns over the motor cortex.

Movement execution, preparation and even observation are usually accompanied by a decrease in µ- and β-rhythm in the cortical area representing the involved body segment. Such a reduction is called event-related desynchronization (ERD).The increase in µ-rhythm, i.e. event-related synchronization (ERS), is observed in the regions of the brain representing body segments, which are not involved in the task.This study is a pilot study to examine the feasibility of a SMR based EEG BCI using motor task and motor imagery and involve a gaming feedback for same.

The first two days will be used for calibrating the BMI using commands in computer screen followed by further two days for testing the BMI and feedback control during gaming in computer to move the ball in the computer screen.

Study Timeline

• Study First Submitted: 2019-10-28
• Study Start: 2019-11-05
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-04
• Last Update Submitted: 2019-12-04
• Study First Posted: 2019-12-05
• Last Update Posted: 2019-12-05
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• • age: 21-75 years

  • Subacute or chronic stroke; interval of at least 3 months and interval of at least 6 months from stroke to time of enrollment, respectively.

  • no cerebellar signs or bilateral motor deficit

  • Cognitive ability to consent, assimilate, and participate actively in the treatment protocol (Mini Mental State Examination score > 24 points, out of a total 30 indicating normal cognitive ability);

  • Modified Rankin scale scores 1-3 (Mild-Moderate functional disability post-stroke);

  • Modified Ashworth Scale of Spasticity score <= 3 (ranges from 0-4 with 4 reflecting maximum spasticity)

  • No epilepsy /usage of antiepileptic drug

    ◦ Subjects with Stroke will be included if they have:

  • unilateral impaired upper limb

  • Able to initiate hand movements like opening and closing fist and no joint contracture or severe spasticity in the affected upper limbs.

  • Sufficient sitting balance to participate in experimental activities.

  • No condition (e.g. severe arthritis, central pain) that would interfere with the administration of motor function tests.

  • English-language comprehension and cognitive ability sufficient to give informed consent (MMSE >=24) and to cooperate with the intervention.

Exclusion Criteria

• • Orthopedic conditions of either upper or lower extremity that would affect performance on the study

  • untreated depression that may affect motivation to participate in the study

  • vascular cognitive impairment interfering with comprehending the tasks

  • Individuals with stroke who have been diagnosed with cognitive or severe visual deficits, hemineglect, uncontrolled angina, or pregnancy

  • no psychiatric or neurological condition other than stroke

    ◦ Stroke will be excluded if they have:

  • Pregnancy (Self -reported)

  • Dementia (MMSE score less than 24)

  • Recurrence of stroke (Occurrence of new focal deficits reported by patient or detected by PI on examination during visits)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EEG BCI closed loop feedback for rehabilitation of upper limb	EEG -BCI based Feedback for rehabilitation	This study is a pilot study to examine the feasibility of a SMR based EEG BCI using motor task and motor imagery and involve a gaming feedback for same. The first two days will be used for calibrating the BMI using commands in computer screen followed by further two days for testing the BMI and feedback control during gaming in computer to move the ball in the computer screen.

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment score (Upper limb)(Min0-Max66;Total 66)	4 days	Change in Hand strength
Decoding motor intent of hand movements using Scalp Electroencephalography(EEG)	4 days	Electroencephalographic spectral power changes during Motor execution and Motor Imagery of hand movements in stroke subjects

Trial Locations

Locations (1)

Subasree Ramakrishnan; 🇺🇸 Houston, Texas, United States