| CTRI Number |
CTRI/2024/03/064293 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
17/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare the efficacy and impact on quality of life of two types of repetitive transcranial magnetic stimulation in chronic migraine patients |
|
Scientific Title of Study
|
To study the efficacy and impact on quality of life of repetitive transcranial magnetic stimulation in chronic migraine patients- A Randomised Open labelled 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 |
Pranjali Batra |
| Designation |
Senior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Neurology, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9417926902 |
| Fax |
|
| Email |
pranjali926@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R N Chaurasia |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Neurology, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9417926902 |
| Fax |
|
| Email |
goforrameshwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R N Chaurasia |
| Designation |
PROFESSOR |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Neurology, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9417926902 |
| Fax |
|
| Email |
goforrameshwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neurology, Banaras Hindu University, Varanasi-221005 ,Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Neurology, Banaras Hindu University, Varanasi-221005, Uttar Pradesh |
| Type of Sponsor |
Government medical college |
|
|
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 PRANJALI BATRA |
BANARAS HINDU UNIVERSITY |
ROOM NO 27, 1ST FLOOR, NEUROLOGY DEPARTMENT, CSS BLOCK, BANARAS HINDU UNIVERSITY
Varanasi
UTTAR PRADESH |
9417926902
pranjali926@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Repetitive Transcranial Magnetic Stimulation |
The Repetitive Transcranial Magnetic Stimulation will be applied using applied using Magstim Rapid-2 (Whiteland, Walsh, UK) with an air-cooled figure-eight coil of 7 cm diameter. The stimulator will be placed anterioposteriorly parallel to midline over the left frontal cortex corresponding to the hot spot of the right abductor digiti minimi, which is approximately 7 cm lateral from the midline and 2 cm anterior to interaural line. The motor threshold will be measured and 70% of it will be used for rTMS and 10 Hz rTMS will be Ten trains of 10 Hz rTMS, each train comprising of 60 pulses with an inter-train interval of 45 seconds will be delivered in one session. Such nine sessions of repetitive transcranial magnetic stimulation will be delivered every alternate day. |
| Comparator Agent |
Repetitive Transcranial Magnetic Stimulation |
The Repetitive Transcranial Magnetic Stimulation will be applied using applied using Magstim Rapid-2 (Whiteland, Walsh, UK) with an air-cooled figure-eight coil of 7 cm diameter. The stimulator will be placed anterioposteriorly parallel to midline over the left frontal cortex corresponding to the hot spot of the right abductor digiti minimi, which is approximately 7 cm lateral from the midline and 2 cm anterior to interaural line. The motor threshold will be measured and 70% of it will be used for rTMS and 10 Hz rTMS will be Ten trains of 10 Hz rTMS, each train comprising of 60 pulses with an inter-train interval of 45 seconds will be delivered in one session. Such three sessions of repetitive transcranial magnetic stimulation will be delivered every alternate day in a month over a period of 3 months |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with migraine without aura with duration of symptoms for more than 15 days in a month for 3 months; non-responsive to medical treatment and willing to give consent will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients with headache secondary to Chronic tension-type and medication overuse
Patients with abnormal computed tomography (CT) or magnetic resonance imaging (MRI) of the brain or with abnormal conventional EEG
Patients with depression as determined by Hamilton Depression scale
Patients with secondary causes of Headache
Pregnant females
Patients with epilepsy or family history of epilepsy
Patients with a pacemaker, intracranial metal objects, and artificial metal tooth will be excluded also from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To look for severity of headache reduction between both the groups |
1 and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To look for improvement in quality of life after treatment between both the groups |
3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
31/03/2024 |
| 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="1"
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
|
Headache is among one of the most common reasons to seek medical care at hospital. It may be debilitating to affect the quality of life and hamper the daily routine activities. Migraine is one of the primary headache disorders . In the Global Burden of Disease Study2010 (GBD2010), it was ranked as the third most prevalent disorder in the world. In GBD2015, it was ranked third–highest cause of disability worldwide in both males and females under the age of 50 years. Migraine that occurs on more than 15 days per month for 3 or more consecutive months is considered chronic migraine. Non invasive neuromodulation techniques are emerging as alternative or as adjunctive treatment in resistant headache disorders. Repetitive transcranial magnetic stimulation(rTMS) suppresses the cortical spreading depression that is pathognomic of headache. Variables to be considered in the application of rTMS are frequency of the pulse, coil geometry and position, rise time, depth penetration and safe stimulator design. It affects the levels of neurotransmitters, regulate synaptic plasticity and changes the neuronal networks that are implicated in the pain pathway. This study is designed to assess the efficacy of rTMS in the management of chronic migraine. |