| CTRI Number |
CTRI/2025/07/091499 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Deep Transcranial Magnetic Stimulation] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A new non-invasive treatment (Deep Transcranial Magnetic Stimulation) for long-term migraine. |
|
Scientific Title of Study
|
Deep Transcranial Magnetic Stimulation (dTMS) for Prophylaxis of Chronic Migraine: A Proof of Concept 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 |
Prof Dr Paresh K Doshi |
| Designation |
Director of Restorative and Regenerative Medicine |
| Affiliation |
Jaslok Hospital and Research Center, Mumbai |
| Address |
Department of Restorative and Regenerative Medicine, 7th Floor South, Jaslok Hospital and Research Centre, 15, Dr. G. Deskhmukh Marg, Mumbai - 400026
15, Dr. G. Deskhmukh Marg, Mumbai - 400026
Mumbai
MAHARASHTRA
400026
India |
| Phone |
9137220165 |
| Fax |
|
| Email |
pareshkd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Paresh K Doshi |
| Designation |
Director of Restorative and Regenerative Medicine |
| Affiliation |
Jaslok Hospital and Research Center, Mumbai |
| Address |
Department of Restorative and Regenerative Medicine, 7th Floor South, Jaslok Hospital and Research Centre, 15, Dr. G. Deskhmukh Marg, Mumbai - 400026
15, Dr. G. Deskhmukh Marg, Mumbai - 400026
MAHARASHTRA
400026
India |
| Phone |
9137220165 |
| Fax |
|
| Email |
pareshkd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Paresh K Doshi |
| Designation |
Director of Restorative and Regenerative Medicine |
| Affiliation |
Jaslok Hospital and Research Center, Mumbai |
| Address |
Department of Restorative and Regenerative Medicine, 7th Floor South, Jaslok Hospital and Research Centre, 15, Dr. G. Deskhmukh Marg, Mumbai - 400026
15, Dr. G. Deskhmukh Marg, Mumbai - 400026
MAHARASHTRA
400026
India |
| Phone |
9137220165 |
| Fax |
|
| Email |
pareshkd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jaslok Hospital and Research Centre, 15, Dr. G Deshmukh Marg, Mumbai-400026, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Jaslok Hospital and Research Centre |
| Address |
15, Dr. G Deshmukh Marg, Mumbai-400026, Maharashtra |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prof Dr Paresh K Doshi |
Jaslok Hospital and Research Centre |
Department of Restorative and Regenerative Medicine, 7th Floor South, Jaslok Hospital and Research Centre, 15, Dr G Deshmukh Marg, Mumbai - 400026
Mumbai
MAHARASHTRA |
9137220165
pareshkd@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jaslok Hospital and Research Centre |
Approved |
| Institutional Ethics Committee Jaslok Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G437||Chronic migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Deep Transcranial Magnetic Stimulation |
The H7 coil will be used to stimulate the bilateral deep frontal regions of the brain using the Brainsway™ dTMS machine. The surface anatomy of the Left Primary Motor Cortex will be identified. The Left M1 will be stimulated at 60% of the machine’s stimulation output in single pulses spaced 5 seconds to elicit the involuntary contraction of the Right Extensor Hallucis Longus. The pulse stimulation will then be gradually decreased to identify the Motor Threshold (MT) of the patient. The lowest intensity at which stimulation elicits a motor response 3 out of 6 times will be recorded as the MT for the rest of the study. Then, the coil will be moved 6 cm forward from the Left MI to align it with the prefrontal cortex. To train the patient for stimulation, impulses of 100-120% intensity of the MT will be delivered in increments of 10% of MT at a 10Hz frequency. Once the patient is trained, the treatment protocol will be started. During each of the 12 treatment sessions, 18 trains of 10 Hz will be given for 2 seconds every 20 seconds. The total duration of each sitting will be 20 minutes. The 12 sessions will be scheduled on alternate days thrice a week for 4 weeks. |
| Comparator Agent |
Sham |
The control group will receive a sham intervention with identical parameters, devices, and helmets. However, when the sham mode is initiated, the active H7 coil will be disabled, and a second coil (sham H7 coil) located within the treatment helmet but far above the participant’s scalp will be activated. This sham H7 coil will deliver a tactile and auditory sensation similar to the active H7 coil, but the electric field does not induce neuronal activation. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria -
1. The patient must have chronic migraine as per ICHD-3:
A. Headache migraine-like or tension-type-like on more than or equal to 15 days a month for more than 3 months, and fulfilling criteria B and C
B. Occurring in a patient who has had at least five attacks fulfilling criteria for Migraine without aura that is
a. Headache attacks lasting 4-72 hr untreated or unsuccessfully treated AND
b. Headache has at least two of unilateral location, pulsating quality, moderate or severe pain intensity, aggravation by or causing avoidance of routine physical activity AND
c. During headache at least one of nausea AND or OR vomiting or photophobia and phonophobia AND or OR criteria for Migraine with aura that is one or more of visual, sensory, speech AND or OR language, motor, brainstem or retinal symptoms AND at least three of one aura symptom spreads gradually over more than or equal to 5 minutes, two or more aura symptoms occur in succession, each individual aura symptom lasts 5-60 minutes, at least one aura symptom is unilateral, at least one aura symptom is positive, the aura is accompanied, or followed within 60 minutes, by headache.
C. On more than or equal to 8 days a month for more than 3 months, fulfilling any of the following:
a. Criteria for Migraine without aura: that is Headache has at least two of unilateral location, pulsating quality, moderate or severe pain intensity, aggravation by or causing avoidance of routine physical activity AND during headache at least one of nausea and/or vomiting or photophobia and phonophobia
b. Criteria for Migraine with aura: One or more of visual, sensory, speech AND or OR language, motor, brainstem or retinal symptoms AND at least three of one aura symptom spreads gradually over more than or equal to 5 minutes, two or more aura symptoms occur in succession, each individual aura symptom lasts 5-60 minutes, at least one aura symptom is unilateral, at least one aura symptom is positive, the aura is accompanied, or followed within 60 minutes, by headache.
c. believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative
D. Not better accounted for by another ICHD-3 diagnosis.
2. The patient must have an unsatisfactory response to at least two prophylactic medications.
3. The patient must be fit for dTMS as per BRAINSway guidelines.
4. The patient must have the ability to understand the language of our assessment tools, here, English. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria -
- The patient must not have shortness of breath while sitting.
- The patient must not have a history of seizures, or a family history of genetic epilepsy, any other chronic pain disorder, severe depression (more than 19 on PHQ-9), or substance abuse.
- Female patients must not be pregnant or breastfeeding.
- The patient must not have a pacemaker or other metallic implant that is unsafe for TMS.
- The patient will be excluded if the investigator determines that the patient is at risk because of participation in the trial or has a physical condition that may influence the results of the trial. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of episodes per month, reduction in intensity (VAS) of each acute episode, reduction in duration of each acute episode, and reduction in the use of abortive medicines. |
Before treatment, Just after treatment, 1 month after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify weather variations in chronic migraine: aura or no aura, severity headache, only nause v/s nausea and vomiting affect responses to dTMS. |
Before treatment, Just after treatment, 1 month after treatment |
| To assess improvement in daily life of patients with chronic migraine in response to treatment with dTMS. |
Before treatment, Just after treatment, 1 month after treatment |
| To assess the safety of dTMS for migraine prophylaxis. |
Before treatment, Just after treatment, 1 month after treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
04/08/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
ABSTRACT:
Introduction: Deep Transcranial Magnetic Stimulation (dTMS) can be an alternative prophylactic treatment for chronic migraine. In the current study, we aim to systematically evaluate the efficacy and safety of dTMS for prophylaxis of Chronic Migraine.
Methodology: We will conduct a randomized, double-blinded, parallel, sham-controlled trial. Patients with chronic migraine as per ICHD-3, will be enrolled in the study. After enrollment, the patients will then be randomized into two groups: dTMS and sham-control. The demographics and clinical history will be recorded. The patient will then be given the Basic Diagnostic Headache Diary (BDHD) to record the number of episodes, duration, site, character, and triggers of each episode, aura, nausea, vomiting, and abortive medications for a month. The assessment of the precise severity of each episode will be done using a 0-100 Visual Analog Scale (VAS). Before initiation of treatment, the impact of the disease on the patient’s quality of life will also be assessed using the Headache Impact Test-6 (HIT-6) and the Migraine Disability Assessment Scale (MIDAS). The dTMS group will receive 12 sessions of dTMS with a Brainsway™ H7 coil, while the sham-controlled group will undergo a dummy paradigm resembling the treatment protocol using the H7 coil. At the end of the treatment, BDHD, VAS, HIT-6, and MIDAS will be recorded again.
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