| CTRI Number |
CTRI/2024/05/067910 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [Transcranial direct current stimulation] |
| Study Design |
Other |
|
Public Title of Study
|
Brain stimulation techniques on Alcohol addiction |
|
Scientific Title of Study
|
Effects of adjuvant Transcranial Direct Current Stimulation (tDCS) on craving and relapse in Patients of Alcohol Dependence Syndrome |
| 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 Bajpai |
| Designation |
Resident, Psychiatry |
| Affiliation |
Base Hospital Delhi Cantt |
| Address |
Dr Shalini Bajpai
Room no.10
Department of Psychiatry
Base Hospital Delhi Cantt
New Delhi
Lucknow
Uttar Pradesh
226017
Dr Shalini Bajpai
MNS Officers Mess
Base Hospital Delhi Cantt
110010
New Delhi
DELHI
110010
India |
| Phone |
7887080047 |
| Fax |
|
| Email |
drbajpai1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj kumar Sharma |
| Designation |
Asst Proff, Psychiatry |
| Affiliation |
Base Hospital Delhi Cantt |
| Address |
Room no-4
Department of Psychiatry
Base Hospital Delhi Cantt
New Delhi
Room no-10
Dr Shalini Bajpai
Department of Psychiatry
Base Hospital Delhi Cantt
New Delhi
110010
New Delhi
DELHI
110010
India |
| Phone |
7875806758 |
| Fax |
|
| Email |
pankajks02@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shalini Bajpai |
| Designation |
Resident, Psychiatry |
| Affiliation |
Base Hospital Delhi Cantt |
| Address |
Room No.10
Department of Psychiatry
Base Hospital Delhi Cantt
New Delhi
Dr Pankaj Kumar Sharma
Room no- 4
Department of Psychiatry
Base Hospital Delhi Cantt
110010
New Delhi
DELHI
110010
India |
| Phone |
7887080047 |
| Fax |
|
| Email |
drbajpai1992@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No-2
Department of Psychiatry
Base Hospital Delhi Cantt
New Delhi
India
110010 |
|
|
Primary Sponsor
|
| Name |
Sqn Ldr Shalini Bajpai |
| Address |
MNS Officers Mess
Base Hospital Delhi Cantt
110010
Contact no- 7887080047 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
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 Bajpai |
Base Hospital Delhi Cantt |
Room No-10
Department of Psychiatry
South West
DELHI |
7887080047
drbajpai1992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Base Hospital & Army College Of Medical Sciences Delhi Cantt |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sham Transcranial direct current stimulation( Sham tDCS) |
Patients of Alcohol Dependence Syndrome found eligible for participation in study after application of inclusion and exclusion criteria will be taken. Candidates for Sham transcranial direct current stimulation(tDCS) will be selected by allocation through random number table. The individuals will be given sham tDCS along with standard treatment (anti-craving medication and psychotherapy) for de-addiction in alcohol dependence syndrome. Individual selected for tDCS will be given 10 cycles of Sham tDCS over 05 days with 02 cycles on each day. The duration of each cycle of tDCS will be 20 minutes. The change in craving and relapse rates will be analysed by reviewing the patient at 1 and 3 months after Sham tDCS while continuing standard treatment. The change will be checked by administration of Penn alcohol craving scale. Value of more than and equal to 20 on Penn alcohol craving scale will be taken as threshold for alcohol craving |
| Intervention |
Transcranial Direct Current Stimulation
( tDCS) |
Patients of Alcohol Dependence Syndrome found eligible for participation in study after application of inclusion and exclusion criteria will be taken. Candidates for transcranial direct current stimulation(tDCS) will be selected by allocation through random number table. The individuals will be given tDCS along with standard treatment (anti-craving medication and psychotherapy) for de-addiction in alcohol dependence syndrome. Individual selected for tDCS will be given 10 cycles of tDCS over 05 days with 02 cycles on each day. The duration of each cycle of tDCS will be 20 minutes. In each cycle, 2 mA of transcranial direct current stimulation will be given. The change in craving and relapse rates will be analysed by reviewing the patient at 1 and 3 months after tDCS while continuing standard treatment. The change will be checked by administration of Penn alcohol craving scale. Value of more than and equal to 20 on Penn alcohol craving scale will be taken as threshold for alcohol craving. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Male |
| Details |
Subjects fulfilling criteria of Alcohol Dependence syndrome as per ICD-10 and willing to give written concent for participation in the study |
|
| ExclusionCriteria |
| Details |
Any axis-1 psychiatric disorder, any other substance use disorder except nicotine, Any implanted metal device, head trauma, seizure, stroke, neurological disease, scalp injury/skip lesion |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess reduction in craving and relapse in patients of Alcohol Dependence Syndrome after application of adjunct tDCS. The assessment will be done at baseline before starting treatment and then after 01 month and 03 months of application of adjunct tDCS. Change in craving will be assessed using Penn Alcohol Craving Scale. Value of 20 or more on the scale will be taken as threshold for craving. |
To assess reduction in craving and relapse in patients of Alcohol Dependence Syndrome after application of adjunct tDCS. The assessment will be done at baseline before starting treatment and then after 01 month and 03 months of application of adjunct tDCS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="1"
Months="6"
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
- What data in particular will be shared?
Response (Others) - Patients details will be kept confidential. However scientific data will be shared
- 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
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identiļ¬ed for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drbajpai1992@gmail.com].
- For how long will this data be available start date provided 06-05-2024 and end date provided 06-08-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
An interventional study will be done in patients of Alcohol Dependence Syndrome who are hospitalised to a tertiary care hospital. All patients meeting ICD-10 criteria of Alcohol Dependence Syndrome admitted to our centre will be taken consent for study. All patients who give consent for study will be screened for inclusion and exclusion criteria. Patients remaining after application of inclusion and exclusion criteria will be assigned a random number centrally, not involving the researcher and study participants. A base line assessment of severity of drinking and craving for alcohol will be done by application of scales. Patients who will be assigned random number 5 and its successive numbers obtained after addition of 10 will be administered 10 cycles of tDCS over 5 days with 02 cycles per day of 20 minutes of each cycle. Patients who will be assigned random number 1, 10 and its successive additions of 10 will be given adjunct sham tDCS for equal number of cycles as true tDCS. Change in craving and relapse rates will be assessed again after 01 month and 03 months of initiation of treatment |