| CTRI Number |
CTRI/2025/08/093417 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Investigating the Effects of iTBS on Cognitive Function in People Recovering from Heroin Addiction |
|
Scientific Title of Study
|
Investigating the Impact of Intermittent Theta Burst Stimulation (iTBS) on Neurocognition. A Comprehensive Examination of Cognitive Functions Post Treatment Efficacy in Heroin Dependent Individuals. A Single Blind Placebo Controlled Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhruv Singh Bangar |
| Designation |
PhD scholar |
| Affiliation |
Postgraduate Institute of Medical Education and Reserach |
| Address |
Drug Deaddiction and Treatment Center, Department of Psychiatry, Neuromodulation Clinic Room Number 201
Drug Deaddiction and Treatment Center, Department of Psychiatry, Neuromodulation Clinic Room Number 201
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9416037349 |
| Fax |
|
| Email |
dhruvbangar60@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Devender Kumar |
| Designation |
Assosiate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Reserach |
| Address |
Drug Deaddiction and Treatment Center, Department of Psychiatry, 160012
Drug Deaddiction and Treatment Center, Department of Psychiatry, 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9988059900 |
| Fax |
|
| Email |
drdevenderrana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhruv Singh Bangar |
| Designation |
PhD scholar |
| Affiliation |
Postgraduate Institute of Medical Education and Reserach |
| Address |
Drug Deaddiction and Treatment Center, Department of Psychiatry, Neuromodulation Clinic Room Number 201
Drug Deaddiction and Treatment Center, Department of Psychiatry, Neuromodulation Clinic Room Number 201
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9416037349 |
| Fax |
|
| Email |
dhruvbangar60@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, PIN 160012 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Madhya Marg, Sector 12, Chandigarh,160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dhruv Singh Bangar |
Postgraduate Institute of Medical Education and Research, Chandigarh |
Drug Deaddiction and Treatment Center, Department of Psychiatry, 160012 Neuromodulation Clinic Room Number 201
Chandigarh
CHANDIGARH |
9416037349
dhruvbangar60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural), Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers with GHQ score Lesser than 2 |
| Patients |
(1) ICD-10 Condition: F112||Opioid dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intermittent Theta Burst Stimulation |
The treatment intervention with stimulation intensity at 80 percent of resting motor threshold (RMT) will consist of bursts delivered at a frequency of 5Hz. Each burst comprising three pulses at a frequency of 50Hz resulting in a total of 1200 pulses per session. Each treatment session will have a duration of approximately 6.7 minutes. Train of bursts will be on for 2 seconds with inter-train interval of 8 seconds. At this rate 180 pulses will be delivered each minute.
Treatment Duration
Patients will undergo two treatment sessions per day, with an interval of 2-3 hours between sessions. The total number of treatment sessions administered over the course of two weeks will consist of 20 sessions . Total Days 14 , Number of Interventions 2 time Daily and it will be 2 session for 5 days in a week
Site of Stimulation
Left dorsolateral prefrontal cortex LDFC (F3). Both active and sham iTBS will be applied at the same position
Equipment Used
Magventure Repetitive Transcranial Magnetic Stimulation Machine (rTMS 100hz) System MagPro XP,200 us,230V TMS Therapy System
COIL-B70 Sham coil- For Sham Intervention |
| Intervention |
Intermittent Theta Burst Stimulation (iTBS) |
The treatment intervention with stimulation intensity at 80 percent of resting motor threshold (RMT) will consist of bursts delivered at a frequency of 5Hz. Each burst comprising three pulses at a frequency of 50Hz resulting in a total of 1200 pulses per session. Each treatment session will have a duration of approximately 6.7 minutes. Train of bursts will be on for 2 seconds with inter-train interval of 8 seconds. At this rate 180 pulses will be delivered each minute.
Treatment Duration
Patients will undergo two treatment sessions per day, with an interval of 2-3 hours between sessions. The total number of treatment sessions administered over the course of two weeks will consist of 20 sessions . Total Days 14 , Number of Interventions 2 time Daily and it will be 2 session for 5 days in a week
Site of stimulation
Left dorsolateral prefrontal cortex LDFC (F3). Both active and sham iTBS will be applied at the same position
Equipment used
Magventure Repetitive Transcranial Magnetic Stimulation Machine (rTMS 100hz) System
MagPro XP,200 us,230V TMS Therapy System
COIL
Active cool -B70 coil- For active Intervention
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age range: 18 to 60 years.
Any sexual orientation.
Giving informed consent in writing.
A DSM 5 (ICD-11) diagnosis of opioid (Heroin) use disorder.
Tobacco dependence will be included.
Basic education level of 8th and above.
Individuals suffering from physical comorbidities like diabetes, HIV, HCV will be included. All participants will be right-handed as per Edinburgh Handedness inventory (1971)-Right Handedness
|
|
| ExclusionCriteria |
| Details |
Individuals who suffer from co-occurring substance use disorders, excluding heroine.
Individuals who have any kind of electrical or metallic intracranial implants.
Women who are nursing or pregnant.
Individuals with intellectual disability.
Individuals suffering from any kind of neurological condition, such as multiple sclerosis, stroke, epilepsy, or encephalopathy. Individuals suffering from primary mood disorders or primary psychosis.
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Intermittent Theta Burst Stimulation (iTBS) in neurocognitive functions, by using a battery of standardized neuropsychological tests, including Raven’s Standard Progressive Matrices, HVLT Learning Test, the WCST-64, the Iowa Gambling Task, the Stroop Test, the Digit Symbol Substitution Test, and the Stop Signal Task. |
Baseline, T3 days, T90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To test saftey and tolerability of the iTBS treatment.
To test iTBS treatment Efficacy in the reduction of craving.
To test the levels of Bio Marker BDNF: Brain-Derived Neurotrophic Factor (BDNF). |
Baseline, T3 days, T90 days |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
15/09/2025 |
| 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="2"
Months="0"
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 - NO
|
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Brief Summary
|
This study aims to examine the impact of Intermittent Theta Burst Stimulation (iTBS) on neurocognitive function in individuals with heroin dependence.The study intends to offer a deeper understanding of how iTBS impacts the neurocognitive aspects of people with heroin dependence through rigorous assessment and analysis. Specifically, post-treatment efficacy, cognitive function and craving It is a clinical trial that follows a single-blind, randomized, placebo-controlled approach. Participants will be categorized into three groups:
The first group will be assigned to receive active iTBS treatment.
The second group will be given sham iTBS as a placebo control.
The third group will be comprised of healthy individuals. (This group will not recive any intervention and are only the control group)
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