| CTRI Number |
CTRI/2018/06/014542 [Registered on: 15/06/2018] Trial Registered Prospectively |
| Last Modified On: |
15/06/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of repetitive transcranial magnetic stimulation and amitryptilline on migraine headache |
|
Scientific Title of Study
|
Evaluation of clinico-electrophysiological profile of episodic migraine and chronic daily headache patients in relation to repetitive transcranial magnetic stimulation given either alone or in combination with amytriptilline |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayantee Kalita |
| Designation |
Professor, Dept of Neurology |
| Affiliation |
sgpgims lucknow |
| Address |
Professor, Dept of Neurology
SGPGIMS, Raebareily road
Lucknow,
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8004904630 |
| Fax |
|
| Email |
jayanteek@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayantee Kalita |
| Designation |
Professor, Dept of Neurology |
| Affiliation |
sgpgims lucknow |
| Address |
Professor, Dept of Neurology
SGPGIMS, Raebareily road
Lucknow,
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8004904630 |
| Fax |
|
| Email |
jayanteek@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayantee Kalita |
| Designation |
Professor, Dept of Neurology |
| Affiliation |
Sanjay Gandhi postgraduate institute of medical sciences(SGPGIMS),lucknow |
| Address |
Professor, Dept of Neurology
Sanjay Gandhi postgraduate institute of medical sciences(SGPGIMS),Raebareily road
Lucknow,
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8004904630 |
| Fax |
|
| Email |
jayanteek@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SGPGIMS, Raebareily road,
Lucknow 226010 |
|
|
Primary Sponsor
|
| Name |
Dr Jayantee Kalita |
| Address |
Professor, Dept of Neurology
SGPGIMS, Raebareily road
Lucknow, pin 226010
|
| Type of Sponsor |
Other [Self] |
|
|
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 Jayantee Kalita |
SGPGIMS Lucknow |
Room no 6,
Neuro lab, E BLOCK
SGPGIMS, Raebareily road,
Lucknow 226010
Uttar Pradesh
Lucknow
UTTAR PRADESH |
8004904630
jayanteek@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, SGPGIMS LUCKNOW |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
primary headache, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
repetitive transcranial magnetic stimulation with amitryptilline |
High frequency RTMS(10 pulses at 12 hz at 70 percent of motor threshold) three sessions on daily basis for three months with amitryptilline initialy 25mg which may be augmented to 50 mg depending upon clinical response. |
| Intervention |
repetitive transcranial magnetic stimulation(RTMS) |
High frequeny RTMS(10 pulses at 12 hz at 70 percent of motor threshold) three sessions on daily basis for three months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
primary headache-migraine and chronic daily headache |
|
| ExclusionCriteria |
| Details |
All patients having any neurological morbidity due to any hereditary, trauma, seizure disorder, meningitis, arterio-veinous malformation, stroke, infection, dyselectrolytemia and any possible secondary cause of headache shall be excluded. Pregnancy, liver or kidney failure, malignancy, uncontrolled diabetis and hypertension or headache with underlying psychiatric illness shall be excluded. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary out come will be defined as 50% decreases in severity and frequency of headache, at each follow-up visit |
1 2 and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effects on habituation viz hearing threshold and brainstem evoked potentials and visual evoked potentials, |
1 2 and 3 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2018 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized parallel group study comparing the efficacy of repetitive transcranial magnetic stimulation(rtms) on migraine/chronic daily headache patients given either alone or in combination with amitryptilline. One group of patients will receive high frequency rtms on daily basis for 3 days for 3 consecutive months.The second group will be given rtms on similar protocol and will also be additionaly given upto 50 mg of amitryptilline. Patient will also be subjected to hearing threshold, brainstem evoked potential and visual evoked potential during the course of treatment. The primary outcome shall be to reduction of frequency and severity of headache in the two group of patients at 1 2 and 3 months. the secondary outcome shall be the effect of treatment on hearing threshold, brainstem evoked potential and visual evoked potential. |