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CTRI Number  CTRI/2022/04/041842 [Registered on: 13/04/2022] Trial Registered Prospectively
Last Modified On: 30/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Transcranial Magnetic stimulation]  
Study Design  Single Arm Study 
Public Title of Study   Repetitive transcranial magnetic stimulation (rTMS) therapy for focal epilepsy in children  
Scientific Title of Study   Efficacy of low frequency repetitive transcranial magnetic stimulation (rTMS) therapy among children with focal onset drug refractory epilepsy – A single arm interventional study  
Trial Acronym  TMS THERAPY 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Col Dr Rahul Sinha 
Designation  Pediatric Neurologist 
Affiliation  Command Hospital 
Address  Department of Pediatrcs, Room no 1 Command Hospital Chandimandir
Department of Pediatrcs, Room no 1 Command Hospital Chandimandir
Panchkula
HARYANA
134109
India 
Phone  8800630109  
Fax    
Email  drrahul_2000@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Col Dr Rahul Sinha 
Designation  Pediatric Neurologist 
Affiliation  Command Hospital 
Address  Department of Pediatrics, Room no 2 Command Hospital Chandimandir
Department of Pediatrics, Room no 2 Command Hospital Chandimandir
Panchkula
HARYANA
134109
India 
Phone  8800630109  
Fax    
Email  drrahul_2000@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Col Dr Rahul Sinha 
Designation  Pediatric Neurologist 
Affiliation  Command Hospital 
Address  Department of Pediatrics, room no 2, Command Hospital Chandimandir
Department of Pediatrics, room no 2, Command Hospital Chandimandir
Panchkula
HARYANA
134109
India 
Phone  8800630109  
Fax    
Email  drrahul_2000@yahoo.com  
 
Source of Monetary or Material Support  
Command Hospital, Chandimandir, Panchkula, Haryana 134109 
 
Primary Sponsor  
Name  DGAFMS 
Address  Office of DGAFMS, L BLOCK,AHQ, New Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rahul Sinha  Command Hospital  Command Hospital Chandimandir
Panchkula
HARYANA 		 8800630109

drrahul_2000@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, Command Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Transcranial Magnetic Stimulation   rTMS 1.Frequency 0.5 Hz 2.Intensity 110% RMT 3.No of pulses/train 1200 4.No of trains 2 trains of 600 each with 3 min gap 5.Stimulation site Epileptogenic foci Coordinates for locating stimulus site 6.10-20 system 7.Type of coil Standard Figure of 8 coil 8.Duration 40 min  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children and adolescents of either sex aged 4 -18 years diagnosed with drug refractory epilepsy as per with ILAE 2017. Drug refractory epilepsy will be defined as ≥ 1 seizure / week OR 4 seizures/month despite on ≥ 2 appropriately chosen and optimally prescribed antiepileptic drugs.
1. Duration of epilepsy for atleast 1 year
2. Seizures of single semiology
3. Majority (75%) of Interictal epileptiform discharges (SWI) arising over a single epileptogenic focus on sleep EEG
4.Parents/ guardians willing to follow the treatment protocol of daily sessions for 10 days in 2 week with Sunday off and hospital follow up at 12 weeks of total study period

 
 
ExclusionCriteria 
Details  1. Hemispheric epilepsy syndromes such as Rasmeussen’s encephalitis, Hemiconvulsion-hemiplegia epilepsy syndrome or Hemimegalancephaly.
2.Diagnosed epileptic encephalopathy other than focal ESES (Electrical status epilepticus in sleep)
3.Diagnosed progressive neurological disorder
4. Previous epilepsy surgery or vagal nerve stimulation insertion.
5.Patient waitlisted for epilepsy surgery within 6 months
6.Presence of Metallic implants anywhere in the body.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the proportion of children and adolescents between 4-18 years, with drug resistant epilepsy, who achieve 50% seizure reduction at 12 weeks follow up compared to baseline.

 		 At baseline
At 12 week post therapy 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare mean reduction in seizure frequency from baseline with low frequency rTMS therapy at follow up period of 12 weeks in children and adolescents aged 4-18 years with focal onset drug refractory epilepsy
2. To determine the proportion of children and adolescents between 4-18 years, with drug resistant focal epilepsy, who achieve 50% reduction in spike wave index in a 30 min sleep interictal video EEG at 12 weeks follow up.
3.To study the change in cortical excitability induced by rTMS therapy in children and adolescents between 4-18 years, with drug resistant epilepsy in terms of pre and post therapy change in motor threshold (MT) using single pulse TMS and SICI and LICI using paired pulses.
4.To study the effect of rTMS on the behavioural profile (as per CBCL) and cognition (MISIC) of children and adolescents between 4-18 years with drug resistant epilepsy.
5.To evaluate the effect of rTMS therapy on Caregiver-rated Impression of Change (CIC) from baseline

 		 Assessment at 3 months 
 
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   N/A 
Date of First Enrollment (India)   18/04/2022 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Up to one third of patients with epilepsy progress to drug resistant epilepsy (DRE). Current treatment options for DRE include ketogenic diet, epileptic surgery and invasive brain stimulation technique like vagal nerve stimulation which requires expertise, cost and not effective for all cases of drug refractory focal epilepsy. rTMS remains one of the safe non invasive technique for refractory focal epilepsy. rTMS is one potential option which needs to be explored thoroughly. The limited Literature regarding therapeutic potential of rTMS in refractory epilepsy is conflicting. The patient and disease characteristics which can predict successful outcome from rTMS therapy is still elusive. No consensus exists on the ideal TMS protocol which can achieve maximum long term efficacy in epilepsy control. None of the rTMS protocols used in literature have been subjected to measurement of change in cortical excitability induced by them. Though safety and tolerability of rTMS in pediatric population is well documented, no pediatric studies are available till date. This study will help to validate the protocol and effectiveness of rTMS in drug resistant epilepsy in children and adolescent between 4-18 years of age.

 
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