| CTRI Number |
CTRI/2017/10/010067 [Registered on: 12/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
29/09/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Experiment of Magnetic stimulation of brain for treatment of fits in children |
|
Scientific Title of Study
|
efficacy of adjunctive neuronavigated rTMS in localization related epilepsy in children and adolescent: a sham controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nirmalya Mukherjee |
| Designation |
Junior resident |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Department of psychiatry, Quarter no 10, married resident quarters, central institute of psychiatry.
Kanke Ranchi
Ranchi
JHARKHAND
834006
India |
| Phone |
8902384825 |
| Fax |
|
| Email |
nirmalya.ik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinod Kumar Sinha |
| Designation |
Professor |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Department of psychiatry, quarter no 1, professors quarter, central institute of psychiatry
Kanke Ranchi
Ranchi
JHARKHAND
834006
India |
| Phone |
8902384825 |
| Fax |
|
| Email |
vinod_sinhacip@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Nirmalya Mukherjee |
| Designation |
Junior resident |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Department of psychiatry, quarter no 10, married resident quarters, central institute of psychiatry
Kanke Ranchi
Ranchi
JHARKHAND
834006
India |
| Phone |
8902384825 |
| Fax |
|
| Email |
nirmalya.ik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry, village-Kanke, District- Ranchi, state- Jharkhand, pin- 834006 |
|
|
Primary Sponsor
|
| Name |
Central Institute of Psychiatry |
| Address |
Kanke Ranchi pin code 834006 Jharkhand |
| 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 |
| Nirmalya Mukherjee |
Central institute of psychiatry |
K S Mani centre for cognitive neuroscience, village - kanke, distrit- Ranchi, pin- 834006
Ranchi
JHARKHAND |
8902384825
nirmalya.ik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| central institute of psychiatry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
diagnosis of localization related epilepsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
repetitive transcranial Magnetic stimulation |
A medical device with capacity to generate high intensity magnetic stimulation to be applied on scalp to stimulate the underlying brain canbe given in various frequencies with frequency less than 1 is called as low frequency and more than one is called high frequency approved for treatment of depression |
| Comparator Agent |
Sham rTMS |
This is the rTMS coil which was placed perpendicular to the scalp |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children and adolescents aged between 8 to 18 years with diagnosis of localization related epilepsy on adequate medicine for atleast 1 month with paroxysms of 4 or more seizures in last one month |
|
| ExclusionCriteria |
| Details |
with mental retardation, severe neurological device metallic device implanted in head neck region not giving consent |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| control of paroxysms of seizures |
upto 3 months after rtms |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in hamilton anxiety rating scale score and childhood depression inventory scores |
up to 3 months after rtms |
| changes in eeg abnormality |
before and after rtms |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/08/2014 |
| Date of Study Completion (India) |
23/02/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study was done in central institute of psychiatry, Ranchi, India, as a post graduate thesis by dr. Nirmalya Mukherjee under the guidance of prof. Vinod Kumar Sinha and co guidance of dr. Nishant Goyal. Total sample size was 30 of either sex, aged between 8 to 18 years with diagnosis of localization related epilepsy as per the ILAE 1981 classifications and having ongoing paroxysms of seizures (at least 4 or more in last month) on adequate dose of anti epileptic for at least one month . Sample was divided equally into two group, active and sham stimulation group by using block randomization. Written informed consent was obtained before the study. Slow frequency (0.3 Hz) rTMS at 100% of resting motor threshold, was applied on the active group for 5 days with figure of 8 coil over vertex with daily 2 sessions of 300 stimulation separated by 30 seconds where as sham group recieved sham stimulation with same parameters. Seizure counts, HAM A and CDI scores were obtained upto three month after rTMS session. EEG was obtained before first and after last rtms. The data was analysed in spss version 20. Results: There was no significant differences in changes in seizure count, HAM A and CDI scores or in EEG in the active group as compared to the sham group. |