| CTRI Number |
CTRI/2025/05/086093 [Registered on: 01/05/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Adjuvant Cerebellar Theta Transcranial Alternating Current Stimulation In Cognitive Symptoms of Schizophrenia |
|
Scientific Title of Study
|
Efficacy of Adjuvant Cerebellar Theta Transcranial Alternating Current Stimulation In Cognitive Symptoms of Schizophrenia: An EEG-Based Randomized Sham-Controlled 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 |
Diptanil Saha |
| Designation |
Junior Resident |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Department of Psychiatry, Central Institute of Psychiatry, Kanke, Ranchi
Ranchi JHARKHAND 834006 India |
| Phone |
8145979425 |
| Fax |
|
| Email |
diptanilsaha15@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Aniruddha Mukherjee |
| Designation |
Professor of Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
KS Mani CCN Lab, Department of Psychiatry, Central Institute of Psychiatry, Kanke, Ranchi
Ranchi JHARKHAND 834006 India |
| Phone |
9474413598 |
| Fax |
|
| Email |
dr_aniruddha@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Aniruddha Mukherjee |
| Designation |
Professor of Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
KS Mani CCN Lab, Department of Psychiatry, Central Institute of Psychiatry, Kanke, Ranchi
Ranchi JHARKHAND 834006 India |
| Phone |
9474413598 |
| Fax |
|
| Email |
dr_aniruddha@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand, India, Pin-834006 |
|
|
Primary Sponsor
|
| Name |
Central Institute of Psychiatry |
| Address |
Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand, Pin- 834006 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Diptanil Saha |
Central Institute of Psychiatry |
KS Mani CCN Lab, Department of Psychiatry, Central Institute of Psychiatry, Kanke, Ranchi Ranchi JHARKHAND |
8145979425
diptanilsaha15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, Central Institute of Psychiatry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Theta Transcranial Alternating Current Stimulation (tACS), Active |
The Strastim 32 (Neuroelectrics) is a wearable device that wirelessly transmits the 32-channel data via Wi-Fi. Its hybrid electrodes can be used for electrical stimulation tACS. It has 20-30 channels with stimulation sampling rate of 1000 SPS and stimulation frequency range of 0-250Hz (tACS). Twice daily sessions of 20 minutes will be administered with at least 3-hour gap between consecutive sessions. Total 20 sessions will be given over 2 weeks. For active theta tACS group, 5 Hz theta tACS will be given for 20 minutes targeting the cerebellar vermis with 1 mA peak to peak amplitude. Anode will be placed 2 cm below inion with cathode electrode on right shoulder.
|
| Comparator Agent |
Theta Transcranial Alternating Current Stimulation (tACS), sham |
For sham, 1 mA current will be applied for 30 seconds in the exact location as stated in active process giving an initial sensation of tACS while minimizing stimulatory effects. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of schizophrenia (6A20) according to International Classification of Diseases, Eleventh Revision (ICD-11), World Health Organization (WHO).
2. Patients willing to give informed consent.
3. Patients aged between 18-60 years of either sex.
4. Illness duration of more than 2 years.
5. MoCA score less than or equal to 25.
|
|
| ExclusionCriteria |
| Details |
1. Presence of comorbid neurological or other psychiatric disorder.
2. Presence of comorbid substance use in dependence pattern, except nicotine and caffeine.
3. Patients who have received ECT in past 6 month.
4. Patients not ready to give 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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in cognitive symptoms in schizophrenia in CANTAB after 20 sessions of theta tACS. |
Change in cognitive symptoms in schizophrenia in CANTAB after 20 sessions of theta tACS measured at baseline, at 2 weeks and at 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in relative theta power in EEG after 20 sessions of theta tACS. |
Change in relative theta power will be noted by measuring at baseline & at 6 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
|
N/A |
|
Date of First Enrollment (India)
|
11/05/2025 |
| 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="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
|
Cognitive impairment in schizophrenia is one of
the most difficult symptom domains to treat with pharmacotherapy and
psychotherapy available at present.
Noninvasive neuromodulation techniques use
either magnetic or electrical stimulation to directly target specific brain
areas, alter neuronal oscillations, cause long-term neuroplasticity changes. Various
neuromodulation techniques including rTMS, tDCS, tRNS, tACS etc. are found to
be well tolerated. Their effect in improving cognitive impairments in
schizophrenia is found to be equivocal. Evidence is limited due to majority of
research having small sample size, some having contradictory findings and lack
of evidence regarding long-term efficacy. (Kar and Singh, 2022) tACS is more
effective at entraining the endogenous brain oscillations as compared to tDCS as
it mimics the alternating nature of brain oscillations. (Elyamany et al., 2021)
According to a study by Parker et. al. (2014),
considering the extensive anatomical connection between cerebellum, thalamus, prefrontal
and anterior cingulate cortex, cerebellar stimulation may restore prefrontal
function and improve cognition in schizophrenia. No serious adverse event was
reported in any study administering tACS to cerebellum in healthy or diseased
population. Singh et. al. conducted a study where single session of theta tACS
was applied on cerebellar vermis in schizophrenia patients which led to changes
in theta activity in frontal cortex but no significant change in performance on
a core cognitive-timing task, concluding that repeated or longer duration tACS
sessions may induce long-lasting or more robust changes in midfrontal oscillatory
activity at lower frequency bands that may lead to significant behavioural
improvement. (Singh et al., 2019) |