| CTRI Number |
CTRI/2025/02/080567 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing efficacy of precision and conventional interventional neuromodulation in patients with young onset mania by using scales, neuroimaging and Transcranial Magnetic Stimulation parameters |
|
Scientific Title of Study
|
Efficacy of precision-based HD-tDCS over conventional HD-tDCS as measured by functional neuroimaging and cortical inhibition paradigms in young-onset mania: An active comparison 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 |
Dr Srijan Das |
| Designation |
Junior Resident, Psychiatry |
| Affiliation |
CENTRAL INSTITUTE OF PSYCHIATRY, RANCHI |
| Address |
KS Mani Centre for Cognitive Neuroscience Lab, Department of Psychiatry, Central Institute of Psychiatry, Ranchi
Ranchi
JHARKHAND
834006
India |
| Phone |
08420489812 |
| Fax |
|
| Email |
johndghosh18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Nishant Goyal |
| Designation |
Professor |
| Affiliation |
CENTRAL INSTITUTE OF PSYCHIATRY, RANCHI |
| Address |
Incharge Consultant Room, K S Mani Centre for Cognitive Neurosciences, Department of Psychiatry, Central Institute of Psychiatry, Ranchi
Ranchi
JHARKHAND
834006
India |
| Phone |
9431171162 |
| Fax |
|
| Email |
psynishant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Sourav Khanra |
| Designation |
Professor of Psychiatry, Centre for Addiction Psychiatry, CIP Ranchi |
| Affiliation |
CENTRAL INSTITUTE OF PSYCHIATRY, RANCHI |
| Address |
Consultant Room, Centre for Addiction Psychiatry, Department of Psychiatry, Central Institute of Psychiatry, Ranchi
Ranchi
JHARKHAND
834006
India |
| Phone |
7903302259 |
| Fax |
|
| Email |
souravpsy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Institute Of Psychiatry, Ranchi, Kanke, Ranchi 834006, Jharkhand, India |
|
|
Primary Sponsor
|
| Name |
Central Institute Of Psychiatry Ranchi |
| Address |
Central Institute Of Psychiatry, Ranchi, Kanke, Ranchi 834006, Jharkhand, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Srijan Das |
Central Institute Of Psychiatry, Ranchi |
K S Mani Centre for Cognitive Neuroscience, Department of Psychiatry, Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand
Ranchi
JHARKHAND |
8420489812
johndghosh18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, CIP Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F30||Manic episode, (2) ICD-10 Condition: F31||Bipolar disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional High-definition transcranial Direct Current Stimulation (HD-tDCS) |
The active control group would receive conventional High-definition transcranial Direct Current Stimulation (HD-tDCS) daily for a duration of 20 minutes for 10 days with sessions spaced at least four hours apart. |
| Intervention |
Precision based High-definition transcranial Direct Current Stimulation (HD-tDCS) |
The interventional group would receive precision-based High-definition transcranial Direct Current Stimulation (HD-tDCS) daily for a duration of 20 minutes for 10 days with sessions spaced approximately 3 hours apart. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of Bipolar type I disorder (6A60) with current episode manic according to the International Classification of Diseases, Eleventh Revision (ICD-11) (WHO, 2019).
2. The age of onset of mania less than 18 years of age belonging to either sex.
3. The current age of the patient is between 10 to 20 years of age.
4. Written informed assent/consent on behalf of participant, parents, guardians or caregivers as applicable.
|
|
| ExclusionCriteria |
| Details |
1. Presence of comorbid other psychiatric or neurological disorders.
2. History of major medical illness.
3. History of epilepsy, sustained brain damage or any neurological procedures.
4. Subjects who have received ECT/rTMS in the past two months.
5. Developmental delay or mental retardation.
6. Any contraindication to undergo fMRI, TMS or HD-tDCS
7. Mixed episodes of depression and mania measured as a score of more than six on HAM-D
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of symptoms of young onset mania, as measured by YMRS Score and severity of illness, as measured by CGI scores after receiving adjunctive precision-based HD-tDCS. |
Primary outcomes are assessed 2 and 6 weeks after intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of functional connectivity, as measured by neuroimaging and enhancement of cortical inhibition as measured by cortical inhibition paradigms in young onset mania after receiving adjunctive precision-based HD-tDCS. |
Secondary outcomes are assessed 2 and 6 weeks after intervention. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/03/2025 |
| 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)
|
Open to Recruitment |
| 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
|
|
Brief Summary
|
As more accurate neuromodulation systems combining high-resolution EEG and anatomical biomarkers develop, it is prudent to evaluate how refined and effective precision neuromodulation is as compared to conventional techniques. Young onset mania provides an ideal challenge for such a comparison considering its poorer prognosis and pharmacological refractoriness. This study aims to be the first to directly compare precision and conventional neuromodulation in child and adolescent populations. It also seeks to study and compare, for the first time, changes in neuroimaging parameters caused due to precision and conventional techniques. By correlating perturbation-induced changes in cortical inhibition paradigms and functional connectivity of cerebral circuits, we aim to introduce a more objective measure of therapeutic efficacy and response, as opposed to relying solely on subjective clinical scales. Furthermore, we aim to study for the first time, task-based differential activation of brain areas in young onset mania. |