Brain Ischemia Clinical Trial
Official title:
EEG Based Brain Computer Interface in Chronic Stroke Survivors for Upper Limb Rehabilitation- A Pilot Study Using Motor Execution and Motor Imagery
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | January 31, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Subasree Ramakrishnan | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Houston |
United States,
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. Review. — View Citation
Ramos-Murguialday A, Broetz D, Rea M, Läer 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fugl-Meyer Assessment score (Upper limb)(Min0-Max66;Total 66) | Change in Hand strength | 4 days | |
Primary | 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 |
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