| CTRI Number |
CTRI/2025/07/091936 [Registered on: 29/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Motor imagery based EEG study for rehabilitation of stroke patients. |
|
Scientific Title of Study
|
Closed Loop Motor Imagery Brain-Computer Interface using Sensorimotor Rhythms and Error-Related Potentials for Neurorehabilitation of Stroke
Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subasree R |
| Designation |
Additional Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neurology
NIMHANS Bangalore
Bangalore KARNATAKA 560029 India |
| Phone |
7899214328 |
| Fax |
|
| Email |
subasree.ramakrishnan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Subasree R |
| Designation |
Additional Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neurology
NIMHANS Bangalore
Bangalore KARNATAKA 560029 India |
| Phone |
7899214328 |
| Fax |
|
| Email |
subasree.ramakrishnan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Subasree R |
| Designation |
Additional Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neurology
NIMHANS Bangalore
Bangalore KARNATAKA 560029 India |
| Phone |
7899214328 |
| Fax |
|
| Email |
subasree.ramakrishnan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research - ICMR
V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar
New Delhi - 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Subasree R |
Room No 230 Stroke Lab 1, NIMHANS |
Department of Neurology, RM Varma Building, Subspeciality Block, Hosur Main Road
Bangalore, 560029 Bangalore KARNATAKA |
7899214328
subasree.ramakrishnan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, (2) ICD-10 Condition: G468||Other vascular syndromes of brainin cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BCI- based intervention |
EEG based BCI intervention will be done using MI & ErrP paradigms. Patients will undergo 3 sessions at 1 weekly interval and there will be 100 trials each lasting for 10 seconds for a given session. Patients will be randomized to MI and MI + ErrP paradigms. The decoding accuracy between the two groups of intervention will be compared. |
| Comparator Agent |
Conventional physiotherapy exercises |
Patients will undergo physiotherapy exercises of upper limb for a period of 3 weeks with the guidance of co-investigator from Neuro-rehabilitation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
l. Stroke patients with Motor paresis or plegia, assessed by Medical Research Council (MRC) grades
2. Both Hemorrhagic strokes and ischemic stroke (TOAST criteria) will be included
3.Cerebral venous thrombosis with focal deficits
4.First ever ischemic/hemorrhagic stroke
5.Patients will be recruited in both acute stages and chronic stages after the onset of stroke
6.CTIMRTshows evidence of stroke(infarct/hemorrhage)
7.Moderate to severe impairment of upper extremity function assessed by FMMA (Fugel-Meyer et al.,
1975) score 10--50
8.Able to understand simple commands and imagine hand movements
9.Patients with adequate motivation and cognitive functioning to perform the experiments/games
(MMSE score ranging from 15 to 30 preferably more than 24) |
|
| ExclusionCriteria |
| Details |
l.Unconscious and Modified Rankin scale score 4
2.Those requiring ventilator support
3.Serious cardiovascular illness
4.Severe Respiratory Distress/ renal diseases
5.Patients with Psychiatric illness
6.Non cooperative participants
7.Stroke Mimics
8.Patients with Isolated CNS vasculitis/ systemic vasculitis, aneurysmal SAH
9.Transient ischemic events
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Fugl Meyer scale for upper limb, Modified Rankin scale (MRC) |
At baseline and after every session weekly for 3 weeks of BCI intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(i) Classification accuracy, Subjectivity & Specificity, (ii) Spatial brain activation maps
(iii) Resting-state functional network connectivity (an indicator of the overall
performance of the brain) & DTI metrics
(iv) Statistical analysis (Wilcoxon non-parametrical t-tests) to assess the statistical significance of the enhancements made
during each session
(v) training completion, adherence rates & adverse events
(vi) User evaluation of the experiment and
tasks. |
Baseline & at the end of every session weekly for 3 weeks of BCI intervention |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A structured summary should contain the following subheadings: Rationale/ gaps in existing knowledge, Novelty, Objectives, Methods, and Expected outcome. Rationale: Stroke is a leading cause of disability globally. Passive movement and motor imagery (MI) induce similar EEG patterns over the motor cortex. Motor imagery based Brain computer interface systems induces brain plasticity and the modulations in the sensory motor rhythm embedded in the EEG can be decoded and translated for control of external devices. The identification and decoding of brain signal patterns associated with MI parameters such as speed and direction is a challenging research problem .In BCI-based neurofeedback, the user’s imagination of hand movement decoded by the BCI is presented to the user as visual feedback. The erroneous neurofeedback perceived by the human brain in the case of erroneous hand movement direction decoding triggers an endogenously elicited brain response termed as Error-Related Potential (ErrP) and can be used to correct the error. Objectives: We aim to develop an online EEG-based MI-BCI for stroke rehabilitation by decoding imagined hand movement kinematics and improve the accuracy of the MI decoding by integrating with ErrP detection. Novelty: Integrating the online realtime multi class MI decoding module with the ErrP detection module to develop an online self-correcting BCI that actuates robotic hand support towards the imagined direction/speed Methods The study design will be a feasibility randomised control study with 15 control subjects of stroke undergoing conventional physiotherapy, 15 subjects of stroke undergoing MI” Intervention and another 15 subjects undergoing “MI with ErrP” Intervention. The functional performance metrics will be documented pre and post BCI intervention and the efficacy assessed. |