Recruiting

EEG Based BCI

Sponsor:

University of Houston

Code:

NCT04188132

Conditions

Stroke Sequelae

Brain Ischemia

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

EEG -BCI based Feedback for rehabilitation

Study Details

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

Study ID

NCT04188132

Start date

Nov 5, 2019

Status verified date

Dec, 2019

Completion date

Jan 31, 2020

Anticipated

Primary completion date

Jan 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

EEG -BCI based Feedback for rehabilitation

Subjects will undergo EEG based BCI as feedback for rehabilitation

Primary outcome measure

  • Fugl-Meyer Assessment score (Upper limb)(Min0-Max66;Total 66) [ Time Frame: 4 days ]
  • Decoding motor intent of hand movements using Scalp Electroencephalography(EEG) [ Time Frame: 4 days ]

Central Contacts and Locations

Central contacts

Subasree R

8326721522subasree.ramakrishnan@gmail.com

Jose CL Vidal

7137434400jlcontr2@central.uh.edu

Locations

Subasree Ramakrishnan

Recruiting

Houston, Texas, United States, 77025

Contacts

Subasree R

832-672-1522sramakr3@central.uh.edu

Jose CL Vidal, PhD

713 7434429jlcontr2@central.uh.edu

More Information

Sponsor

University of Houston

Last update posted

Dec 5, 2019

Last verified

Dec, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Houston on 2019-12-05.