EEG Based BCI for Upper Limb Rehabilitation in Stroke

NCT04188132 | Unknown DMC

• 1 other identifier: STUDY00001846
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Sequelae; Brain Ischemia

Outcome Measures

Primary Outcomes (2)

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

  Change in Hand strength

  4 days

• 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

  4 days

Study Arms (1)

EEG BCI closed loop feedback for rehabilitation of upper limb

EXPERIMENTAL

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.

Other: EEG -BCI based Feedback for rehabilitation

Interventions

EEG -BCI based Feedback for rehabilitation OTHER

Subjects will undergo EEG based BCI as feedback for rehabilitation

EEG BCI closed loop feedback for rehabilitation of upper limb

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Houston: lead

Study Sites (1)

Subasree Ramakrishnan

Houston, Texas, 77025, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 18835541 BACKGROUND

• 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.

  PMID: 23494615 BACKGROUND

MeSH Terms

Conditions

Brain Ischemia

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Subasree R

  University of Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Subasree R

CONTACT

8326721522; subasree.ramakrishnan@gmail.com

Jose CL Vidal

CONTACT

7137434400; jlcontr2@central.uh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Professor

Model Details: Pilot study in patients with fulfilling the eligibility criteria

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: December 5, 2019
• Study Start: November 5, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: December 5, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)