| CTRI Number |
CTRI/2024/03/063896 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Neuromodulation Transcranial Alternating Current Stimulation] |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy of Adjunctive Alpha TRANSCRANIAL ALTERNATING CURRENT STIMULATION in Obsessive Compulsive Disorder. |
|
Scientific Title of Study
|
Efficacy of adjunctive alpha TRANSCRANIAL ALTERNATING CURRENT STIMULATION in Obsessive Compulsive Disorder as measured by functional MAGNETIC RESONANCE IMAGING:A sham controlled 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 Miss Daisy Sarkar |
| Designation |
Junior Resident |
| Affiliation |
Central Institute of Psychiatry |
| Address |
CIP ranchi
Ranchi
Jharkhand
834006
India
Ranchi
JHARKHAND
834006
India |
| Phone |
8918624090 |
| Fax |
|
| Email |
daisysarkar5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Daya Ram |
| Designation |
Director Professor of Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Central Institute of Psychiatry Kanke Ranchi Jharkhand 834006 India
Ranchi
Jharkhand
834006
India
Ranchi
JHARKHAND
834006
India |
| Phone |
7856866667 |
| Fax |
|
| Email |
dram_cip@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Daya Ram |
| Designation |
Director Professor of Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Central Institute of Psychiatry Kanke Ranchi Jharkhand 834006 India
Ranchi
Jharkhand
834006
India
Ranchi
JHARKHAND
834006
India |
| Phone |
7856866667 |
| Fax |
|
| Email |
dram_cip@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry,Kanke, Ranchi,Jharkhand,834006 |
|
|
Primary Sponsor
|
| Name |
Central Institute of Psychiatry |
| Address |
Kanke Ranchi,Jharkhand,834006 |
| 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 |
| Miss Daisy Sarkar |
Central Institute of Psychiatry |
KS Mani CCN Lab and fMRI centre Psychiatry Department Central Institute of Psychiatry Kanke Ranchi Jharkhand
Ranchi
JHARKHAND
Ranchi
JHARKHAND |
8918624090
daisysarkar5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee CIP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F42||Obsessive-compulsive disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transcranial Alternating Current Stimulation(tACS) Active |
Electrode positioning will be adjusted according to the 10–20 EEG system. The anode will be
placed at Fp1 and the return electrodes will be placed at Fpz, Afz, AF3, AF7. A pulsed alternating
current will be applied with the maximum current at any given electrode (1 cm2) being 200
mA, with a total current of tACS 2 mA for each active session. The parameter settings for each
active Alpha-tACS session will be: a 5 s ramp up, 30 min of Alpha tACS with 10 Hz, and a 5s
ramp down. Total Duration of 30 min 10 sec |
| Comparator Agent |
Transcranial Alternating Current stimulation(tACS) Sham |
A sham condition applied for a duration of 30s with 5 seconds ramp up and 5 seconds ramp down.This reproduces somatic sensations similar to active stimulation. During the Alpha-tACS application, the participants will be in a resting condition.Total duration of 40 seconds.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of obsessive compulsive disorder according to ICD 11 DCR(WHO,2022).
Age between 18- 60 years of either sex.
Patients with YBOCS score of 16 or above.
Patients should be on stable dose of antiobsessive and antipsychotic medications.
Right-handed.
Patients who have not received Cognitive Behavioural Therapy in the past 2 weeks of the study.
Patients with mild to moderate depression associated with obsessive compulsive disorder.
Patients giving written informed consent. |
|
| ExclusionCriteria |
| Details |
OCD with severe depression as measured by HDRS score more than 24.
Presence of co-morbid neurological or other psychiatric disorder(s).
Patient with co morbid substance dependence, except nicotine and caffeine.
Having any metallic implants/parts in body.
Patients not giving written informed consent |
|
|
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 and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in YBOCS SCORE from baseline after
application of 20 sessions of alpha tACS. |
Primary outcome variable will be Reduction in YBOCS SCORE from baseline at the end of 2 weeks after
application of 20 sessions of alpha tACS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in BOLD activation in Orbitofrontal Cortex after application
of 20 sessions of alpha tACS. |
Secondary outcome variable will be changes in BOLD activation in Orbitofrontal Cortex after application
of 20 sessions of alpha tACS at the end of 2 weeks. |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
19/03/2024 |
| 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 Yet Recruiting |
| 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
|
OCD is a major mental health condition accompanied by severe distress, high levels of disability, and disruption of the person’s social and occupational functioning.In the functional neuroanatomy of OCD, a critical role has been assigned to the orbitofrontal cortex (OFC), a brain region crucially involved in reward-guided learning and decision making.Transcranial alternating current stimulation (tACS) is a form of non-invasive brain stimulation which modulates neural oscillations in humans by application of weak electric current to the scalp.Current medication and behaviour therapies in OCD, although effective in most patients, fail to provide adequate benefit in many patients most severely affected.Although studies done on TMS and tDCS have shown promising results, the opinion about their efficacy on OCD as a treatment modality remains equivocal.The past studies using tACS on OCD population to be effective but it includes only case series, case reports and studies on non-clinical population.To the best of our knowledge, no study has been done targeting the OFC using tACS in OCD population, hence this study intends to assess the efficacy of tACS on OFC in OCD population. |