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EEG Based BCI for Upper Limb Rehabilitation in Stroke

Primary Purpose

Stroke Sequelae, Brain Ischemia

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

EEG -BCI based Feedback for rehabilitation

About this trial

This is an interventional health services research trial for Stroke Sequelae

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Subasree RamakrishnanRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EEG BCI closed loop feedback for rehabilitation of upper limb

Arm Description

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.

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment score (Upper limb)(Min0-Max66;Total 66)

Change in Hand strength

Decoding motor intent of hand movements using Scalp Electroencephalography(EEG)

Electroencephalographic spectral power changes during Motor execution and Motor Imagery of hand movements in stroke subjects

Secondary Outcome Measures

Full Information

NCT ID

NCT04188132

First Posted

October 28, 2019

Last Updated

December 4, 2019

Sponsor

University of Houston

1. Study Identification

Unique Protocol Identification Number

NCT04188132

Brief Title

EEG Based BCI for Upper Limb Rehabilitation in Stroke

Official Title

EEG Based Brain Computer Interface in Chronic Stroke Survivors for Upper Limb Rehabilitation- A Pilot Study Using Motor Execution and Motor Imagery

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 5, 2019 (Actual)

Primary Completion Date

January 31, 2020 (Anticipated)

Study Completion Date

January 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke Sequelae, Brain Ischemia

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Pilot study in patients with fulfilling the eligibility criteria

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EEG BCI closed loop feedback for rehabilitation of upper limb

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

EEG -BCI based Feedback for rehabilitation

Intervention Description

Subjects will undergo EEG based BCI as feedback for rehabilitation

Primary Outcome Measure Information:

Title

Fugl-Meyer Assessment score (Upper limb)(Min0-Max66;Total 66)

Description

Change in Hand strength

Time Frame

4 days

Title

Decoding motor intent of hand movements using Scalp Electroencephalography(EEG)

Description

Electroencephalographic spectral power changes during Motor execution and Motor Imagery of hand movements in stroke subjects

Time Frame

4 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Subasree R

Phone

8326721522

subasree.ramakrishnan@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jose CL Vidal

Phone

7137434400

jlcontr2@central.uh.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Subasree R

Organizational Affiliation

University of Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

Subasree Ramakrishnan

City

Houston

State/Province

Texas

ZIP/Postal Code

77025

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Subasree R

Phone

832-672-1522

sramakr3@central.uh.edu

First Name & Middle Initial & Last Name & Degree

Jose CL Vidal, PhD

Phone

713 7434429

jlcontr2@central.uh.edu

First Name & Middle Initial & Last Name & Degree

Andrew Paek, RA

First Name & Middle Initial & Last Name & Degree

Akshay Ravindran, RA

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Currently not planning for data sharing

Citations:

PubMed Identifier

18835541

Citation

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.

Results Reference

background

PubMed Identifier

23494615

Citation

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.

Results Reference

background

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EEG Based BCI for Upper Limb Rehabilitation in Stroke

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