| CTRI Number |
CTRI/2023/12/060797 [Registered on: 27/12/2023] Trial Registered Prospectively |
| Last Modified On: |
26/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [rTMS ] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
efficacy of repetitive transcranial magnetic stimulation (rTMS)in chronic migraine with vestibular symptoms |
|
Scientific Title of Study
|
To study the Efficacy of repetitive transcranial magnetic stimulation (rTMS)in chronic migraine with vestibular symptoms, An open labelled randomized sham control 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 |
Dr Karnati Uday Kumar |
| Designation |
Senior resident |
| Affiliation |
aiims bhubaneswar |
| Address |
Department of Neurology AIIMS Bhubaneswar Sijua Dumuduma Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
09052698569 |
| Fax |
|
| Email |
karnatiudaykumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Kumar Bhoi |
| Designation |
proffesor |
| Affiliation |
aiims bhubaneswar |
| Address |
Department of Neurology AIIMS Bhubaneswar Sijua Dumuduma Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9919787978 |
| Fax |
|
| Email |
bhoisanjeev@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karnati Uday Kumar |
| Designation |
Senior resident |
| Affiliation |
aiims bhubaneswar |
| Address |
Department of Neurology AIIMS Bhubaneswar Sijua Dumuduma Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9052698569 |
| Fax |
|
| Email |
karnatiudaykumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhubneswar , sijua , patrapada , 751019 |
|
|
Primary Sponsor
|
| Name |
AIIMS Bhunaneswar |
| Address |
sijua, patrapada, bhubaneswar |
| 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 |
| Karnati Uday Kumar |
AIIMS Bhubaneswar |
Department of Neurology, room no - 237, sijua, patrapada, BHUBANESWAR
Khordha
ORISSA |
9052698569
karnatiudaykumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G438||Other migraine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
repetitive transcranial magnetic stimulation (rTMS) |
Each rTMS session will last 412.4 seconds and deliver 600 pulses.The impulses will be delivered in 10 trains, each containing 60 pulses at 10 Hz and with 45-second intertrain interval. There will be three sessions offered on alternate days. total of 3 sessions . |
| Comparator Agent |
standard medication for migraine |
standard medication for migraine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
a)Patients fulfilling the diagnostic criteria of chronic migraine according to ICHD-3criteria , that is headaches on 15 days or more days per month in a patient with prior migraine history , with at least 8 days per month being migraine for at least 3 months .
b)Patients with chronic migraine with vestibular symptoms .
c)Adults of > 18 years of age. |
|
| ExclusionCriteria |
| Details |
a)Patients with prior history of hearing loss ,non migranous vestibular symptoms , hearing aids , implants .
b)Patients with pregnancy,CLD,CKD,malignancy,severe hypertension, pacemaker or metallic implants, and history of seizures or structural brain lesions , advanced heart failure have been excluded . |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The primary outcome measures were defined at 1 month as
follows:
a)Reduction in headache frequency by 50%
b)Improvement in severity on Visual Analogue
Scale (VAS) (0-100) by 50 %
c)Functional disability
d)Adverse events
e)Reduction of DHI score 50% |
The primary outcome measures were defined at 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome will be
1. To study the assessment of VEMP
a)Mean peak latency N10 , P15 and amplitude N10-P15 oVEMP.
b)Mean peak latency of P13, N23 and amplitude of P13- N23 of cVEMP .
c)Inter aural difference with Asymmetric ratio( AR) of oVEMP, cVEMP. |
The outcome parameters were noted after each rTMS session; thereafter at the 4th week. The patients visited for follow-up at 1 month |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/01/2024 |
| 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="6"
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
|
Migraine is a disease that stays lifelong . It needs abortive treatment for acute headache and prophylactic treatment for recurrent headache. Experimental and human research have shown that abnormality of trigeminovascular system, brainstem and cerebral cortex are involved in migraine pathogenesis. It has been shown experimental studies that single pulse of transcranial magnetic stimulation (TMS) can interrupt cortical excitability in depression(6,7) . This finding has opened the gate for evaluating the TMS for acute migraine treatment.High-frequency rTMS may increase the cortical activity found in controlling pain(8) or decrease cortical excitation(9). So this can be used in migraine prophylaxis. Repetitive Transcranial magnetic stimulation (rTMS) is a painless, easy to deliver, affordable neurophysiological technique widely used as treatment. It produces sub or suprathreshold currents by electromagnetic induction, in the cortex. There are two types of rTMS modalities are available. One is high-frequency (HF-rTMS) stimulation (>1 Hz).It increases excitability of motor cortex of the stimulated area. Second is low-frequency (LF-rTMS) stimulation (⩽1 Hz) .It usually causes a reduction in cortical excitation .Coil position during rTMS session is defined by the area where motor threshold (MT) is recorded. MT is defined as lowest transcranial magnetic stimulation intensity needed to produce a motor evoke potential (MEP) of amplitude >50µv in at least 6 of 10 trials. The rTMS role has been proven in other disease like depression, migraine prophylaxis with minimal side effects. Various studies has shown mixed results about rTMS role in migraine prophylaxis. In 27 migraine patients who are given Low-frequency rTMS shown improvement of headache frequency but without significant difference with respect to sham stimulation group(9). There are two studies with High-frequency rTMS. A study, involving 11 migraine patients , with 6 patients receiving 400 pulses of rTMS at 20 Hz at 90 % of MT for 12 sessions and five patients received sham stimulation(8). Frequency of headache, rescue pill intake decreased significantly. In rTMS group this effect persisted for 8 weeks . This effect of rTMS was not shown in other studies. Low-frequency rTMS has was not effective when two trains of one Hz ,500 pulses was given for five contineous days(9) . An open-labeled trial shown ten Hz rTMS consisting of 600 pulses in ten trains on alternate days for three days was given(10). This trial shown efficacy in decreasing headache frequency by more than 50 % among 80 % of patients. This benefit stayed for four weeks . These variability about effect of rTMS as prophylaxis in chronic migraine is needed to be addressed. |