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CTRI Number  CTRI/2022/05/042876 [Registered on: 27/05/2022] Trial Registered Prospectively
Last Modified On: 05/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Prolonged Theta Burst Stimulation]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of prolonged Theta burst stimulation on pain perception  
Scientific Title of Study   Effect of Prolonged Theta Burst Stimulation Protocols on Corticomotor Excitability and Pain Perception in Healthy Subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Renu Bhatia 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences , New Delhi 
Address  Room no. 6007, Pain Research and TMS laboratory Convergence Block AIIMS , New Delhi

South West
DELHI
110029
India 
Phone  8860169671  
Fax    
Email  renuaiims28@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Avany Sathyan 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences , New Delhi 
Address  Room no. 6007 Pain Research and TMS laboratory Convergence Block AIIMS , New Delhi

South West
DELHI
686631
India 
Phone  8882792326  
Fax    
Email  avany.rox@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Renu Bhatia 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences , New Delhi 
Address  Room no. 6007, Pain Research and TMS laboratory Convergence Block AIIMS , New Delhi


DELHI
110029
India 
Phone  8860169671  
Fax    
Email  renuaiims28@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  All India Institute of Medical Sciences Ansari Nagar New Delhi - 110029 
Type of Sponsor  Research institution and hospital 
 
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 Renu Bhatia  All India Institute of Medical Sciences New Delhi   Room no. 6007 Pain Research and TMS laboratory Convergence block All India Institute of Medical Sciences New Delhi
South West
DELHI 		 8860169671

renuaiims28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethical Committee- All India Institute of Medical Sciences, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  none  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  corticomotor excitability and Quantitative sensory testing  recording of Motor evoked potential, Resting motor threshold, tactile and thermal thresholds 
Intervention  prolonged theta burst stimulation  theta burst stimulation given in 3 modalities 1. prolonged continuous for 80 sec 2. prolonged intermediate for 3 min 47 sec 3. sham stimulation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  right handed
healthy
 
 
ExclusionCriteria 
Details  chronic pain disorders
pregnant or lactating
neuropsychiatric illness
on medication for neuropsychiatric illness
known case of epilepsy
subject with metal implants 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Corticomotor Excitability  Before Stimulation
5 mins after stimulation
50 min after stimulation 
 
Secondary Outcome  
Outcome  TimePoints 
Tactile And Pain threshold and Tolerance for Temperature and Pressure  Before Stimulation
50 min after stimulation 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   31/05/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/05/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [renuaiims28@gmail.com].

  6. For how long will this data be available start date provided 26-03-2024 and end date provided 26-10-2025?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study looks into the effect of prolonging the duration of continuous and intermediate theta burst stimulation protocols on corticomotor excitability and pain perception. The limited studies so far have shown inconclusive results for prolonged continuous theta burst stimulation and prolonged intermediate theta burst protocol yet to be explored. This study will help us to conclude whether or not prolonged TBS protocols are as useful as the conventional protocols . It would take 20-30 min to assess baseline CME and QST parameters followed by 1.5 to 5 min of prolonged TBS, then CME at 5 min post stimulation. This will be followed by 45 min rest and again 20-30 min to assess final CME and QST parameters. Null Hypothesis in this study is that the prolonged TBS protocols have no effect on CME and Pain perception with the alternative hypothesis being that either prolonged continuous or prolonged intermediate or both TBS protocols have an effect on either corticomotor excitability or pain perception or both.  

 
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