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CTRI Number  CTRI/2024/11/077116 [Registered on: 20/11/2024] Trial Registered Prospectively
Last Modified On: 29/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [rTMS as compared to established treatment propranolol in patients of episodic migraine prevention]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Transcranial magnetic stimulation in comparison to oral Propranolol in prevention of episodic Migraine 
Scientific Title of Study   rTMS vs Propranolol in Prevention of Episodic Migraine: A Randomized Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepika Joshi 
Designation  Professor 
Affiliation  BHU varanasi 
Address  Department of Neurology, banaras Hindu University
BHU varanasi
Varanasi
UTTAR PRADESH
221101
India 
Phone  9918978666  
Fax    
Email  drdeepikajoshi73@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anand Vardhan 
Designation  Senior Resident 
Affiliation  BHU varanasi 
Address  Department of Neurology, CSSB Building First Floor, Room no 1, BHU varanasi

Varanasi
UTTAR PRADESH
221101
India 
Phone  06280799087  
Fax    
Email  varanand.26@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anand Vardhan 
Designation  Senior Resident 
Affiliation  BHU varanasi 
Address  Department of Neurology, CSSB Building First Floor, Room no 1, BHU varanasi


UTTAR PRADESH
221101
India 
Phone  06280799087  
Fax    
Email  varanand.26@gmail.com  
 
Source of Monetary or Material Support  
Department of Neurology OPD room no 206 and In patients from Neurology Ward CSSb Building, BHU varanasi-221005, India, both In and outpatients of episodic migraine will be enrolled in the study 
 
Primary Sponsor  
Name  Dr Anand vardhan 
Address  senior Resident, Department of Neurology, CSSB Building First Floor, Room no 1, BHU varanasi-221005 
Type of Sponsor  Other [thesis study] 
 
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 
Anand Vardhan  Department of Neurology  Banaras Hindu University
Varanasi
UTTAR PRADESH 		 6280799087

varanand.26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BHUIMS Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G438||Other migraine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Propranolol  the study group will be given an established treatment in the form of oral propranolol in predetermined dose of oral tablet propranolol starting with 40mg and gradually going upto 80 mg in one week and along with placebo of rTMS with no effect will be given for a period of three session per week withe equal spacing days for three months 
Intervention  Repetitive transcranial magnetic stimulation   out of 2 study groups ,rTMS with predetermined frequency• Ten trains of 10 Hz rTMS, each train comprising of 60 pulses with an inter-train interval of 45 seconds will be delivered on the left frontal cortex in one session. Each session comprised of 600 pulses. Three sessions of rTMS will be delivered in a week with equal spacing of days and will be repeated every month for 3 months. along with placebo of tab propranolol will be given to a study arm and other study arm will be given placebo of rTMS and tab propranolol in fixed dose 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  In this prospective follow up study, we will enroll patients with Episodic migraine as per ICHD-3 criteria and satisfying age criteria will fall between 18 years and 55 years.Patients who are already taking medications for migraine and having washout period of atleast 1 month.Patients residing within the radius of 5 kms from the centre who can come for follow up
 
 
ExclusionCriteria 
Details  Patients with major psychiatric or neurological disease (stroke, epilepsy, head injury or tumor), malignancy, liver, or kidney failure, on migraine prophylaxis in the last 2 weeks or on immunotherapy, Patients with hypertension, cardiac diseases, bronchial asthma uncontrolled diabetes, bleeding disorders, or pregnancy, any contraindication to propranolol will also be excluded. Those unwilling to give consent will be excluded.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
At 3 month, clinical outcome/ response and cGRP levels will be assessed of every patient and will be correlated with headache severity, intensity, frequency and duration.
The primary outcome will be ≥ 50% reduction in headache days.
 		 At 3 month, clinical outcome/ response and cGRP levels will be assessed of every patient and will be correlated with headache severity, intensity, frequency and duration.
The primary outcome will be ≥ 50% reduction in headache days.
The secondary outcomes will be the reduction in severity, number of abortive medications, and side effects.
The exact frequency of headache, VAS score, and number of abortive medications will also be evaluated in both groups.
 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes will be the reduction in severity, number of abortive medications, and side effects.
The exact frequency of headache, VAS score, and number of abortive medications will also be evaluated in both groups.
 		 3 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   27/11/2024 
Date of Study Completion (India) 28/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 Migraine ranks as the leading cause of years lived with disability in people younger than 50 years of age. various treatment and preventive therapies have been proposed till date for migraine. Here we are studying the comparison of rTMS with standard established medical therapy in patients with Episodic migraine. rTMS is an established add-on treatment modality along with drug therapy in migraine patients, but it is yet to be studied as an independent preventive and treatment modality. Patients will be enrolled from in patient as well as out patient department of neurology, banaras hindu university. This will be a randomised placebo controlled blinded trial in which 2 study arms will be assigned after proper randomisation in which one arm will be given tab propranolol with the sham of rTMS and the other arm will be given rTMS as the therapy along with placebo of propranolol. Baseline CGRP levels will also be compared with the after intervention values (3 months). various tools will be applied to know the severity of the illness like MIDAS, HIT questionnaire, migraine disability index done before the intervention and 3 months after the inytervention. predetermined frequency of rTMS pulse will be given to the patients, a total of 3 sessions/month for 3 months will be given. rTMS is yet to be proven as an independent modality in prevention of episodic migraine, this study and will be helpful for the patients who are suffering from episodic migraine and will serve a way for further studies in this field. 
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