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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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)

 
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