Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
10 participants
INTERVENTIONAL
2019-11-05
2020-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology
NCT04141774
Safety and Effectiveness of Cortical Stimulation in the Treatment of Stroke Patients With Upper Extremity Hemiparesis
NCT00170716
Wireless Brain-computer-interface-controlled Neurorehabilitation System for Patients With Stroke
NCT01880268
BCI for Hemiparetic Upper Extremities in Patients Due to Stroke
NCT05778448
Biofeedback After Stroke
NCT07149129
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
EEG -BCI based Feedback for rehabilitation
Subjects will undergo EEG based BCI as feedback for rehabilitation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EEG -BCI based Feedback for rehabilitation
Subjects will undergo EEG based BCI as feedback for rehabilitation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
21 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Houston
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Subasree Ramakrishnan
Visiting Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Subasree R
Role: PRINCIPAL_INVESTIGATOR
University of Houston
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Subasree Ramakrishnan
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00001846
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.