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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
 
 
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.
 
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