EEG Based BCI for Upper Limb Rehabilitation in Stroke

NCT ID: NCT04188132

Last Updated: 2019-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-05

Study Completion Date

2020-01-31

Brief Summary

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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

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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.

Conditions

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Stroke Sequelae Brain Ischemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot study in patients with fulfilling the eligibility criteria
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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EEG BCI closed loop feedback for rehabilitation of upper limb

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.

Group Type EXPERIMENTAL

EEG -BCI based Feedback for rehabilitation

Intervention Type OTHER

Subjects will undergo EEG based BCI as feedback for rehabilitation

Interventions

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EEG -BCI based Feedback for rehabilitation

Subjects will undergo EEG based BCI as feedback for rehabilitation

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Houston

OTHER

Sponsor Role lead

Responsible Party

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Subasree Ramakrishnan

Visiting Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Subasree R

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Locations

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Subasree Ramakrishnan

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Subasree R

Role: CONTACT

8326721522

Jose CL Vidal

Role: CONTACT

7137434400

Facility Contacts

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Subasree R

Role: primary

832-672-1522

Jose CL Vidal, PhD

Role: backup

713 7434429

References

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Daly JJ, Wolpaw JR. Brain-computer interfaces in neurological rehabilitation. Lancet Neurol. 2008 Nov;7(11):1032-43. doi: 10.1016/S1474-4422(08)70223-0. Epub 2008 Oct 2.

Reference Type BACKGROUND
PMID: 18835541 (View on PubMed)

Ramos-Murguialday A, Broetz D, Rea M, Laer L, Yilmaz O, Brasil FL, Liberati G, Curado MR, Garcia-Cossio E, Vyziotis A, Cho W, Agostini M, Soares E, Soekadar S, Caria A, Cohen LG, Birbaumer N. Brain-machine interface in chronic stroke rehabilitation: a controlled study. Ann Neurol. 2013 Jul;74(1):100-8. doi: 10.1002/ana.23879. Epub 2013 Aug 7.

Reference Type BACKGROUND
PMID: 23494615 (View on PubMed)

Other Identifiers

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STUDY00001846

Identifier Type: -

Identifier Source: org_study_id

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