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CTRI Number  CTRI/2024/05/066729 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 01/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Non-invasive brain stimulation in improving cognitive and motor function in stroke patients. 
Scientific Title of Study   Optimization and efficacy of Non–Invasive Brain stimulation on Cognitive and Motor function in stroke patients - A Randomised control trial study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ayesha Juhi 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Deoghar 
Address  Department of Physiology, AIIMS Deoghar, Devipur, Rohini, Deoghar, Jharkhand, PIN: 814152

Deoghar
JHARKHAND
814152
India 
Phone  8008770156  
Fax    
Email  ayesha.physiology@aiimsdeoghar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Ayesha Juhi 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Deoghar 
Address  Department of Physiology, AIIMS Deoghar, Devipur, Rohini, Deoghar, Jharkhand, PIN: 814152

Deoghar
JHARKHAND
814152
India 
Phone  8008770156  
Fax    
Email  ayesha.physiology@aiimsdeoghar.edu.in  
 
Details of Contact Person
Public Query  
Name  Ayesha Juhi 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Deoghar 
Address  Department of Physiology, AIIMS Deoghar, Devipur, Rohini, Deoghar, Jharkhand, PIN: 814152

Deoghar
JHARKHAND
814152
India 
Phone  8008770156  
Fax    
Email  ayesha.physiology@aiimsdeoghar.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Deoghar, Devipur, Deoghar, Jharkhand, 814152, India. 
Extramural project funded by ICMR Under Investigators initiated small grant scheme-2023 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
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 Ayesha Juhi  All India Institute of Medical Sciences, Deoghar  Research lab, Department of Physiology , 4th floor, Zone 2, Academic Building. Devipur campus: 814152
Deoghar
JHARKHAND 		 8008770156

ayesha.physiology@aiimsdeoghar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Deoghar, Institutional Ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I619||Nontraumatic intracerebral hemorrhage, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  rTMS – repetitive transcranial magnetic stimulation and dTCS- transcranial direct current stimulation   Total duration: Each subject in the allocated group will receive the assigned therapy (Active rTMS OR Active tDCS) of a single session of 20 mins duration for 5 days a week for consecutive 6 weeks. Active rTMS group: Repetitive transcranial magnetic stimulation is a non-invasive brain stimulation technique that involves the use of magnetic pulses to stimulate specific regions of the brain. The target site for rTMS in stroke patients is usually the motor cortex of the affected hemisphere. The 10-20 EEG system will be used to estimate the location of the motor cortex, which is the target site for TMS in stroke patients. The motor cortex is located in the frontal lobe of the brain, near the central sulcus. Electrodes will be placed on the scalp at the corresponding locations, which are typically C3 and C4 for the left and right motor cortices, respectively. Once the target site is identified, the TMS coil is positioned over the appropriate scalp location, which corresponds to the underlying motor cortex target site. The coil is placed perpendicular to the scalp surface, and the handle of the coil is usually pointed posteriorly. The intensity and frequency of the magnetic pulses delivered during the TMS procedure can be adjusted. In this study we shall use 3 different hertz of frequency 0.5hz, 5 hz and 10 hz for optimization of the procedure for 20 mins stimulation. Active t DCS: Transcranial direct current stimulation (tDCS) used for motor impairments, the target site is the motor cortex of the affected hemisphere, while for cognitive impairments, the target site may vary depending on the specific cognitive domain affected. Electrode for the tDCS will be placed on the patients scalp at the predetermined target site, using the appropriate size and configuration of electrodes. The anode electrode is placed over the target site, while the cathode electrode is placed on a nearby location, such as the contralateral supraorbital area. With the help of 10-20 EEG system for selecting a target site for tDCS, the electrode positions can be adjusted to correspond to the cortical region of interest. A current intensity of 0.5,1 and 5Ma will be used for 20 mins stimulation. 
Comparator Agent  Sham intervention r TMS Sham intervention t DCS  The comparator -Sham control group will receive the assigned Sham control(sham rTMS or Sham tDCS) for 5 days a week for consecutive 6 weeks. Each session of Sham control will be 20mins. Sham intervention r TMS : The most commonly used method for sham control in rTMS is called "sham coil" or "placebo coil." This involves using a coil that looks and sounds like a real rTMS coil, but does not deliver any magnetic stimulation to the brain. The sham coil is typically designed to produce the same sensory sensations as a real coil, such as a tapping or clicking sound and a sensation of scalp twitching or tingling, but without actually inducing any electrical currents in the brain. Total duration of 20 mins. Sham intervention t DCS :The use of a sham coil allows the participant and the rTMS technician to be blinded to whether the participant is receiving the real treatment or the placebo treatment. This helps to minimize bias and placebo effects, and allows for more accurate assessment of the true effects of the treatment being tested. method used is a "ramp-up" technique, where the current is slowly ramped up to a high intensity over the first 30-60 seconds of the session and then quickly turned off. This creates the same initial tingling or itching sensation on the scalp that is experienced during real tDCS, but does not actually deliver any electrical stimulation to the brain. Total duration of 20 mins. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)First ever and haemorrhagic stroke/ischemic stroke with responsible lesions located in unilateral basal ganglia and/or corona radiate region confirmed by a brain computed tomography or magnetic resonance imaging
2)Stable vital signs, no deterioration of neurological symptoms 
3)Post stroke duration of 1 month to 6 months 
4)Aged between 18 and 65 years (both sexes) 
5)Fugl Meyer Assessment score to assess motor skills more than 50 
6)With cognitive disability with MoCA score of less than 25
7)Stroke patients without severe aphasia, visual or hearing impairment so as to be capable of fulfilling the study protocol 
 
ExclusionCriteria 
Details 
1)Patients with metal implants in the body , 
2)History of seizures or family history, 
3)Severe cardiopulmonary disease and multiple organ failure, 
4)Malignant tumours, and 
5)Severe mental illness, 
6)Previous history of encephalitis, 
7)Brain trauma, 
8)Alzheimer’s disease and dementia, t 
9)Hose with severe visual, hearing or communication impairment.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in cognitive and motor function   The cognitive and motor function of the subjects will be assessed at 3 different point of time.
1. Before the intervention, that is the baseline status.
2. During the intervention ,1st day of 4th week
3. During the completion of intervention date ,that is the 6th week (last day).

 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in cognitive and motor function in stroke patients   6 months (after the intervention) 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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   N/A 
Date of First Enrollment (India)   15/05/2024 
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  

Background: Stroke is one of the main causes of disability worldwide, affecting the patient’s motor, sensory, and cognitive skills. Non-invasive brain stimulation treatments such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) have been found to help in rehabilitation of stroke victims. However, there is a need to optimize the parameters of these techniques to maximize their efficacy in stroke rehabilitation. 

Novelty: The proposed study aims to explore the optimization of non-invasive brain stimulation parameters for stroke rehabilitation, which is an underexplored area of research. The study will focus on the comparison of the both the techniques, which among them is more effective in improving motor and cognitive function in stroke patients. And also to understand which of the technique is more cost effective. Above all this study would explore what is the efficacy of the both the techniques by studying the long term follow up. 

Objectives: The main objectives of the study are: 

 

To determine the optimal parameters for rTMS and tDCS in stroke rehabilitation, including frequency, intensity, and duration of stimulation. 

To compare the effectiveness of rTMS and tDCS in improving cognitive and motor functions in stroke patients. 

To explore the efficacy of rTMS and tDCS by studying the long-term effects of rTMS and tDCS on cognitive and motor functions in stroke patients. 

 

Methods:  The study is a randomised control trial study. Participants will be recruited from AIIMS Deoghar, local hospitals and rehabilitation centres at Deoghar district. Inclusion criteria will include a diagnosis of stroke, aged between 18 and 65 years, and a score of ≤ 25 on the Montreal Cognitive Assessment (MoCA) test and Fugl Meyer test for Motor function assessment with mild to moderate stroke condition. A total of 128 study participants will be selected for the study. Participants will be randomly assigned to one of four groups: active rTMS, active tDCS, sham interventional group of both techniques and standard therapy alone. The active groups will receive 20 minutes of stimulation daily for 6 weeks. While the sham groups will receive a placebo stimulation of 20 mins . The primary outcome measures will be the change in the MoCA score and the Fugl-Meyer assessment (FMA) of cognitive and motor function respectively. Data analysis will be conducted using repeated-measures analysis of variance (ANOVA) and post-hoc comparisons. 

Expected outcome:  The proposed study is expected to contribute to the optimization of non-invasive brain stimulation parameters for stroke rehabilitation. The study may lead to the development of new and more effective rehabilitation strategies for stroke patients. The results of this study will also help to determine the long-term effects(efficacy) of non-invasive brain stimulation on cognitive and motor function in stroke patients. 

 
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