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CTRI Number  CTRI/2025/05/086282 [Registered on: 05/05/2025] Trial Registered Prospectively
Last Modified On: 05/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Effect of deep transcranial magnetic stimulation (dTMS) on Craving, Heart Rate Variability and Cognitive Performance in Heroin Dependent Users 
Scientific Title of Study   Effect of 1Hz repetitive, deep transcranial magnetic stimulation (dTMS) over right Inferior Frontal gyrus, right Anterior Insula on Craving, Heart Rate Variability and Cognitive Performance in Heroin Dependent Users – A Proof of Concept Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shalini Naik 
Designation  Assistant Professor 
Affiliation  Postgradute Institute of Medical Education and Research 
Address  Department of Psychiatry, PGIMER, Madhya Marg, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9886313489  
Fax    
Email  drshalini.anji@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shalini Naik 
Designation  Assistant Professor 
Affiliation  Postgradute Institute of Medical Education and Research 
Address  Department of Psychiatry, PGIMER, Madhya Marg, Chandigarh


CHANDIGARH
160012
India 
Phone  9886313489  
Fax    
Email  drshalini.anji@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shalini Naik 
Designation  Assistant Professor 
Affiliation  Postgradute Institute of Medical Education and Research 
Address  Department of Psychiatry, PGIMER, Madhya Marg, Chandigarh


CHANDIGARH
160012
India 
Phone  9886313489  
Fax    
Email  drshalini.anji@gmail.com  
 
Source of Monetary or Material Support  
Department of Science, Technology and Renewable Energy, Paryavaran Bhawan, 1st floor, Sectore 19B, MAdhya Marg, Chandigarh -160019, India  
 
Primary Sponsor  
Name  Department of Science & Technology & Renewable Energy 
Address  1st Floor, Paryavaran Bhawan, Madhya Marg, Sector 19 B, Chandigarh- 160019 
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 Shalini Naik  Postgraduate Institute of Medical Education and Research  Room no: 227, first floor, Drug De-addiction and Treatment Centre [DDTC], Department of Psychiatry, PGIMER, Madhya Marg, Chandigarh 160012
Chandigarh
CHANDIGARH 		 9886313489

drshalini.anji@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F112||Opioid dependence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Repetitive Transcranial Magnetic Stimulation (rTMS)  They will receive 20 twice-daily 1Hz rTMS sessions, each session of 1500 pulses at 110 RMT of leg motor region, over right Inferior Frontal Gyrus (rIFG) and right Anterior Insula (rAI) (they are identified as 1/3 of the distance between F8 and C6 on 10-20 EEG system, in previous studies) using MagVenture Double-cone coil (DCC), over 2 weeks. They will view heroin-related visual image cues while receiving 1Hz rTMS pulses and rate their subjective experience of craving on VAS. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients with a diagnosis of moderate to severe Heroin use disorder by the Diagnostic and Statistical Manual of Mental Disorders -5 (DSM-5)

2. Score greater than or equal to 4 on VAS

3. Providing written informed consent 
 
ExclusionCriteria 
Details  1. Patients with neurological disorders like multiple sclerosis, stroke, epilepsy, encephalopathy due to any cause
2. Patients with a history of significant head injury, brain tumour or any brain surgery
3. Patients with primary psychotic or mood disorder or other substance use disorder except nicotine
4. Pregnant and lactating females
5. Any electronic or metal implants
6. Any contraindications for TMS as assessed by the TMS Adult Safety Screen (TASS) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in subjective report of craving measured using the Desire for Drug Questionnaire (DDQ) and Verbal Analogue Scale (VAS)  Assessments will be performed at baseline (Day 0), Immediately after the end of 20 twice-daily rTMS sessions (Day 10), and at 4 weeks, i.e., 28 days after the termination of rTMS course (Day 38)  
 
Secondary Outcome  
Outcome  TimePoints 
Change in an objective measure of craving using heroin visual image cue-elicited HRV measures, consumption of heroin measured using timeline follow back (TLFB), decision-making abilities and response inhibition assessed on CGT and SST, respectively.  Secondary endpoint (Day 38): 4 weeks i.e., 28 days after the termination of 20 rTMS sessions 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   16/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  16/05/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [drshalini.anji@gmail.com].

  6. For how long will this data be available start date provided 15-05-2025 and end date provided 14-05-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Previous study at our centre found hyperactivation of right inferior frontal gyrus and right anterior insula when heroin dependent users experienced craving on exposure to I-CARE cues. Use of DCC over rIFG might offer to let the induced electrical pulses reach the immediately underlying rAI. Simultaneous inhibition of these two adjacent cortical regions with the help of 1Hz dTMS when exposed to heroin-related cues, will cause decrease in subjective report of craving (DDQ, VAS) and decrease in the sympathetic tone on HRV during I-CARE paradigm, an objective measure of craving. Better inhibitory function of rIFG and rAI might improve decision making on CGT and inhibition of undesired response on SST, the two key cognitive impairments implicated in Craving and relapse.
 
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