| CTRI Number |
CTRI/2024/02/063354 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
12/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effect of magnetic stimulation over scalp in patients suffering from migraine. |
|
Scientific Title of Study
|
The effect of intermittent theta burst repetitive transcranial magnetic stimulation in the treatment of chronic migraine: A double-blind sham-controlled 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 Sujita Singh |
| Designation |
MD postgraduate in Psychiatry |
| Affiliation |
AIIMS, Raipur |
| Address |
AIIMS Psychiatry Office, C- Block
First floor, AIIMS Raipur, Tatibandh Raipur. State-Chhattisgarh. Pincode-492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
8210686303 |
| Fax |
|
| Email |
sujitasingh0861@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Associate Professor, Dept. of Psychiatry |
| Affiliation |
AIIMS, Raipur |
| Address |
AIIMS Psychiatry office C- Block
First floor, AIIMS Raipur, Tatibandh, Raipur. State-Chhattisgarh. Pincode-492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
8210686303 |
| Fax |
|
| Email |
ajaypgimer2016@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujita Singh |
| Designation |
MD postgraduate in Psychiatry |
| Affiliation |
AIIMS, Raipur |
| Address |
AIIMS Psychiatry office C- block
first floor, AIIMS Raipur, Tatibandh, Raipur. State-Chhattisgarh. Pincode-492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
8210686303 |
| Fax |
|
| Email |
sujitasingh0861@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Psychiatry, AIIMS, Raipur |
|
|
Primary Sponsor
|
| Name |
Sujita Singh |
| Address |
AIIMS Psychiatry office, C-Block,1st floor AIIMS Raipur Tatibandh Raipur, Chhattisgarh,Pincode-492099 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ajay Kumar |
Dept of Psychiatry, AIIMS, Raipur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sujita Singh |
All India Institute of Medical Sciences, GE Road, Tatibandh, Raipur-492099,Chhattisgarh |
Department of Psychiatry, AIIMS, Raipur, first floor, C-Block ,GE Road, Tatibandh, Raipur-492099
Raipur
CHHATTISGARH |
8210686303
sujitasingh0861@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, Raipur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G43||Migraine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intermittent theta burst repetitive transcranial magnetic stimulation |
Active group: active coils using stimulus intensity of 80% of MT, with Frequency-50 Hz, burst frequency-5Hz, delivered 1000 pulse in 20 cycles. |
| Comparator Agent |
Intermittent theta burst repetitive transcranial magnetic stimulation. |
Sham group: sham coils using stimulus intensity of 80% of MT, with Frequency-50 Hz, burst frequency-5Hz, delivered 1000 pulses in 20 cycles. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with migraine, diagnosed according to the International Classification of Headache Disorders (ICHD-3rd edition)
2.Age between 18-60 years
3.Sex: all gender
4.Written informed consent for the study obtained from the participants.
5.With or without any prophylactic treatment.
|
|
| ExclusionCriteria |
| Details |
1.Any other type of chronic or recurrent headache such as diagnosed as sinusitis, refractive errors, cervical spondylosis, and neurological conditions.
2.Neuropsychiatry disorders Organic brain conditions, History of severe head injury, epilepsy, space occupying lesion, trigeminal neuralgia, hydrocephalous, meningitis, and other pain conditions.
3.Otherwise physically healthy conditions
4.Psychogenic pain, tension headache, Somatoform pain disorder
5.Use of botulinum toxin in head or neck region in last 6 months.
6.Active phase of any major Psychiatry illness (Schizophrenia, Bipolar disorder), substance use disorder (except moderate tea and nicotine use).
7.Active phase of depression
8.Confirmed Pregnancy
• Having cochlear implant, cardiac pacemaker and metal body implanted in the body.
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in migraine days, frequency, severity, and duration in migraine in chronic migraine patient |
patient is assessed for severity, intensity, and duration of migraine by MIDAS, Headache Impact Test-6 (HIT-6)and migraine dairy at 4th, 6th, and 12th week of post-intervention period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the improvement from the bassline in intensity of migraine attacks and burden of drugs used for the episode of migraine in the active rTMS and sham rTMS group. |
4th,6th and 12th week of post intervention period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/03/2024 |
| 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="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
|
Title: Effect of intermittent theta burst repetitive transcranial magnetic stimulation in treatment of chronic migraine: A double-blind sham-controlled Introduction Migraine is characterized by episodes of headaches, usually unilateral pulsating, associated with photophobia, phonophobia, nausea and/or vomiting, typically lasting 4-72 hours. There is growing evidence of the effective use of transcranial magnetic stimulation using stimulation over the left prefrontal cortex. Recent evidence suggests the effective use of theta burst protocol on the left prefrontal cortex, reducing the severity and frequency of migraine episodes. We aim to explore the effectiveness of a theta burst protocol in managing migraines in our institute using a randomized, sham-controlled design. Aim and objectives: to assess the efficacy of adjunctive prophylactic use of intermittent theta-burst stimulation (iTBS) on left DLPFC in a patient with Chronic migraine. Methodology: The participants undergo observation and assessment for two weeks to determine their migraine pattern. Following this, the intervention started using the protocol: a. Stimulus intensity: 80% of Resting Motor threshold (RMT), Frequency-50 Hz, Burst frequency-5Hz. b. A total of 1000 pulses are delivered in 20 cycles. c. Number of sessions: 5 sessions in 5 days. d. Patient assessed for any rTMS-related side effects (i.e., rTMS induced Headache) the patient is assessed for severity, intensity, and duration of migraine by MIDAS, Headache Impact Test-6 (HIT-6), Pain Numbering Rating Scale (NPRS) and migraine dairy in the 4th, 6th, and 12th week of the post-intervention period. Participants recruited by purposive sampling A total of 60 participants (30 in each group) were randomized by block randomization, resulting in active and sham-controlled groups. The active arm received true stimulation, while the controlled arm received only sham protocol. Participants are to be assessed with the help of the Hamilton Depression Rating Scale (HAMD), Migraine Disability Scale (MIDAS), Numeric Pain Rating Scale (NPRS), and Headache Impact Test-6. We hypothesised that the theta burst stimulation of the left dorsolateral prefrontal cortex effectively reduces migraine episodes in terms of severity, frequency and duration. |