| CTRI Number |
CTRI/2012/04/002545 [Registered on: 04/04/2012] Trial Registered Retrospectively |
| Last Modified On: |
29/03/2012 |
| 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
|
Role of repetitive transcranial magnetic stimulation (rTMS) in migraine prophylaxis a randomized control trial |
|
Scientific Title of Study
|
A randomized placebo controlled trial evaluating the safety and efficacy of rTMS in migraine prophylaxis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr U K Misra |
| Designation |
Prof & HOD |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) |
| Address |
Dept. of Neurology, C-Block,
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Raebarely Road, Lucknow, UP
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
0522-2494167 |
| Fax |
0522-2668811 |
| Email |
drukmisra@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U K Misra |
| Designation |
Prof & HOD |
| Affiliation |
SGPGIMS |
| Address |
Dept. of Neurology, C-Block
SGPGIMS, Raebarely Road, Lucknow, UP
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
0522-2494167 |
| Fax |
0522-2668811 |
| Email |
drukmisra@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr U K Misra |
| Designation |
Prof & HOD |
| Affiliation |
SGPGIMS |
| Address |
Dept. of Neurology, C-Block
SGPGIMS, Raebarely Road, Lucknow, UP
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
0522-2494167 |
| Fax |
0522-2668811 |
| Email |
drukmisra@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| Address |
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebarely Road, Lucknow,UP. |
| Type of Sponsor |
Research institution |
|
|
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 U K Misra Dept of Neurology Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow UP |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
Dept. of Neurology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebarely road, Lucknow, UP
Lucknow
UTTAR PRADESH |
05222494167
0522-2668811
drukmisra@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGPGI, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients of Migraine headache of more than 15 years age. No history of focal neurological deficit, no associated comorbidities like uncontrol hypertension, renal failure, pregnancy, lactation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo stimulation |
Patients left prefontal cortex will be stimulated by placebo coil (Magstim Rapid, Whitland, Wales, UK). For similar duration as with active arm. |
| Intervention |
Repetitive transcranial magnetic stimulation |
Patients left prefrontal cortex will be stimulated by repetitive transcranial magnetic coil(Magstim Rapid, Whitland, Wales, UK).
Each session consisted of 600 pulses in 412.4 sec. The impulses were given in 10 trains each consisting of 60 pulses at 10Hz with inter-train interval of 45 seconds. Three sessions of stimulation were given on alternate day |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of migraine headache with frequency of attacks more than four attcaks per month. |
|
| ExclusionCriteria |
| Details |
Pregnancy, liver or kidney diseases, malignancy, severe hypertension, pacemaker or metallic implants and history of seizure or structural brain lesions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. More than 50% improvement in frequency of headache
2. Global improvement in VAS |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity of headache, Functional improvement, rescue analgesic intake and somatosensory evoked potential before and after rTMS in selected patients |
1 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/07/2011 |
| 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) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Headache is one of the most common neurological disorders seen in the outpatient department in our institute. On an average, two of ten patients evaluated by a neurologist in the outpatient department, have migraine. The disease has disabling potential, with the greatest impact on public health. The goals of migraine preventive therapy are to: (1) reduce attack frequency, severity, and duration; (2) improve responsiveness to treatment of acute attacks; and (3) improve function and reduce disability. Prophylaxis for migraine includes various classes of drugs alpha-2 agonist, antiepileptics, antidepressants, SSRIs, monoamine oxidase inhibitors, beta blockers, calcium channel blockers. rTMS has been reported to have beneficial effects in migraine with aura and rTMS has shown to be beneficial in reducing migraine frequency in some studies. This prospective randomized control study will investigate the efficacy and safety of rTMS in comparison with sham stimulation in the prophylactic treatment of migraine headache. |