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CTRI Number  CTRI/2025/12/099033 [Registered on: 15/12/2025] Trial Registered Prospectively
Last Modified On: 02/08/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Effects of deep rTMS as an add on therapy on Neurophysiological, Cognitive and Clinical outcomes in patients with opioid dependence 
Scientific Title of Study   Effects of deep rTMS as an add on therapy on Neurophysiological, Cognitive and Clinical outcomes in patients with opioid dependence 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr TN Sathyaprabha 
Designation  Professor 
Affiliation  NIMHANS 
Address  Department of Neurophysiology, NIMHANS, Bangalore, 560029

Bangalore
KARNATAKA
560029
India 
Phone  08026995172  
Fax    
Email  drsathyaprabha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr TN Sathyaprabha 
Designation  Professor 
Affiliation  NIMHANS 
Address  Department of Neurophysiology, NIMHANS, Bangalore, 560029

Bangalore
KARNATAKA
560029
India 
Phone  08026995172  
Fax    
Email  drsathyaprabha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr TN Sathyaprabha 
Designation  Professor 
Affiliation  NIMHANS 
Address  Department of Neurophysiology, NIMHANS, Bangalore, 560029

Bangalore
KARNATAKA
560029
India 
Phone  08026995172  
Fax    
Email  drsathyaprabha@gmail.com  
 
Source of Monetary or Material Support  
NIMHANS, Hosur main road, Lakkasandra, Ayappa garden, Adugodi,Bengaluru, Karnataka, India, 560029 
 
Primary Sponsor  
Name  NIMHANS 
Address  NIMHANS, Hosur Road, BANGALORE, 
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 
Madhu Priya  NIMHANS  Room no. 1010, CNN LAB, New OPD Block, NIMHANS Hospital, Hosur road, Bangalore
Bangalore
KARNATAKA 		 8789664752

madhupriya3797@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, NIMHANS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F111||Opioid abuse,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Active Deep TMS  Active Deep rTMS targetting bilateral PFC and insula will be given for 5 days. (3 sessions per day)  
Comparator Agent  Sham TMS  Sham TMS will be given 23 patients and will be compared with active TMS group patients 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Opioid use disorder patients (diagnosed by DSM-V criteria)
o Age: 18 – 45 years
o Either gender
o Right-handed
o Normal / Corrected to normal vision
o Written informed consent
o Clinical Opiate Withdrawal Scale (COW) score of 0
o Education: ability to read and write  
 
ExclusionCriteria 
Details  o History of any other psychiatric disorders
o Any neurological disorders including epilepsy
o Any other known systemic disorders
o Presence of any metal implants in head  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Craving score (using VAS scale)  Craving score (using VAS scale) 
 
Secondary Outcome  
Outcome  TimePoints 
Scales/questionnaires, EEG functional connectivity and cognitive task measures, TMS excitability measures, HRV   Baseline (DAY 0); Post-intervention (Day5)

 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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   Phase 4 
Date of First Enrollment (India)   02/01/2026 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - 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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [madhupriya3797@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 02-01-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Opioids are extensively used in medical practice, primarily for their potent analgesic properties in managing pain. Due to their ability to provide profound pain relief, opioids are commonly administered as anesthetic agents during and after surgery for effective pain management. opioids exert their effects by binding to specific opioid receptors that are found throughout central nervous system and peripheral tissues. When these receptors are activated, they trigger the release of dopamine in the nucleus accumbens, a key brain region involved in the processing of reward and pleasure. This surge in dopamine leads to intense feelings of euphoria and reinforces the behavior of substance use, making it more difficult for individuals to resist further consumption. Medications like buprenorphine, naltrexone, and methadone are commonly used to treat opioid dependence and have shown promising results.
Despite the medication-assisted treatment and behavioral interventions, sustained recovery remains a challenge due to the chronic relapsing nature of this disorder. There is a persistent high relapse rate ranging from 40 percent to 77 percent within the first six months of treatment. These troubling statistics highlight the need for novel therapeutic strategies to overcome the limitations of current treatment methods. 
In the current study, we aim to administer Deep rTMS as an add-on therapy in opioid dependence using H4 coil targeting bilateral PFC and insula.
 
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