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CTRI Number  CTRI/2025/06/089351 [Registered on: 23/06/2025] Trial Registered Prospectively
Last Modified On: 17/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Other (Specify) [Neuromodulation]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Real World Study on Effect of Cerebellar adjuvant Transcranial Direct Current Stimulation (tDCS) on Negative Symptoms of Schizophrenia: A Double-blinded Sham-controlled Pilot Trial 
Scientific Title of Study   Effect of Adjuvant Cerebellar Anodal Transcranial Direct Current Stimulation (tDCS) on Negative Symptoms of Schizophrenia: A Pilot Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shilpa Mandal 
Designation  Psychiatrist 
Affiliation  Armed Forces Medical College, Pune 
Address  Dept of Psychiatry, Golden Jubilee Block, Armed Forces medical College, Pune

Pune
MAHARASHTRA
411004
India 
Phone  7679463274  
Fax    
Email  mandal.pritish.shilpa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shilpa Mandal 
Designation  Psychiatrist 
Affiliation  Armed Forces Medical College, Pune 
Address  Dept of Psychiatry, Golden Jubilee Block, Armed Forces medical College, Pune


MAHARASHTRA
411004
India 
Phone  7679463274  
Fax    
Email  mandal.pritish.shilpa@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shilpa Mandal 
Designation  Psychiatrist 
Affiliation  Armed Forces Medical College, Pune 
Address  Dept of Psychiatry, Golden Jubilee Block, Armed Forces medical College, Pune


MAHARASHTRA
411004
India 
Phone  7679463274  
Fax    
Email  mandal.pritish.shilpa@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Shilpa Mandal 
Address  Dept of Psychiatry, Golden Jubilee Block, Armed Forces Medical College, Pune - 411004 
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 
Dr Shilpa Mandal  Armed Forces Medical College  OPD and IPD of Dept of Psychiatry, Golden Jubilee Block, Armed Forces Medical College, Pune
Pune
MAHARASHTRA 
7679463274

mandal.pritish.shilpa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Armed Forces Medical College, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F205||Residual schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adjuvant cerebellar anodal tDCS  Patients in Treatment as Usual + tDCS group will be administered tDCS additionally. We will use a table top tDCS device. Each patient will receive 05 sessions of anodal tDCS (2mA) during 20 minutes for 5 consecutive days through surface electrodes covered by saline-soaked sponges. The electrode position will be determined by the International EEG 10–20 System. The anodal electrode will be positioned over the central cerebellum (2cm below the inion), the reference electrode will be positioned over the right supraorbital region (Fp2) 
Comparator Agent  Sham tDCS  Patients in control group will receive treatment as usual + sham tDCS. For the sham condition the device’s inbuilt programme “Sham tDCS” will be used. Anodal electrode will be positioned over the central cerebellum (2cm below the inion), the reference electrode will be positioned over the right supraorbital region (Fp2).Each patient will receive 05 sessions of Sham tDCS during 20 minutes for 5 consecutive days through surface electrodes covered by saline-soaked sponges 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of Schizophrenia with negative symptoms aged between 18-60 years and consenting for the study will be enrolled. They will be randomized to receive treatment as usual+ adjuvant cerebellar anodal tDCS and treatment as usual+sham 
 
ExclusionCriteria 
Details  1. Those diagnosed with Neurodevelopmental disorders, Depressive disorders, OCD, Dissociative disorders, Eating disorders, Alcohol and Substance use disorders.
2. Neurological conditions like Movement disorders, Multiple sclerosis, Epilepsy, Cerebrovascular diseases and CNS infections.
3. Those having uncontrolled Diabetes, Hypertension or acute or chronic inflammatory conditions.
4. Those with history of endocrine diseases involving disorders of thyroid gland, parathyroid gland and adrenal gland.
5. Pregnant or lactating patients.
6. Those who have  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
effect of adjunctive Cerebellar anodal tDCS on Negative Symptoms  End of fifth session 
 
Secondary Outcome  
Outcome  TimePoints 
Association between duration of illness & improvement in negative symptoms after adjuvant cerebellar anodal tDCS  End of fifth session 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/06/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be available at google and icloud. link will be generated after completion of study and data deidentification. Data will be available to those requestors who will sign a data access agreement.

  6. For how long will this data be available start date provided 01-06-2026 and end date provided 01-06-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

 

Schizophrenia, a disabling mental disorder is characterized by cluster of both negative and positive symptoms. The positive symptoms are characterized by delusions, hallucinations and disorganization in thinking and behaviour. The negative symptoms refer to reduction of normal behaviour in the form of avolition, anhedonia, asociality, affective flattening and alogia. Whereas, the positive symptoms respond better to the available antipsychotic medications, the response of these medications in negative symptoms are meagre. There is also concern that negative symptoms run a chronic progressive course that leads to overall poor outcomes in the patient’s personal, social and occupational domains.

A recent study has shown that dysconnectivity between dorsolateral prefrontal cortex to cerebellum network directly corresponds to negative symptom severity. Another study involving 260 individuals with negative symptoms supported the evidence that reduced connectivity between the cerebellar-prefrontal network is associated with negative symptoms.

In recent researches, various non-invasive cerebellar stimulation at the vermis has shown to improve the negative symptoms of schizophrenia by improving the connectivity between the cerebellum and the prefrontal cortex. A systematic review further adds on to the evidence to positive outcomes of cerebellar stimulation. Amongst various NIBS techniques, most studied techniques are repeated transcranial magnetic stimulation (rTMS) and theta burst stimulation at cerebellum.

Indeed, some researchers have already used transcranial Direct Current Stimulation (tDCS) as a treatment for schizophrenia, evaluating effects over its common positive and negative symptoms. tDCS is a NIBS technique where direct current in the range of 0.5 to 2 mA is passed through the scalp by means of electrodes over designated areas of interest with an aim is to modulate the activity of specific brain region. Till date there is only 01 descriptive study including 04 patients investigating the effects of anodal tDCS over the cerebellum and primary motor cortex in schizophrenic patients suffering from tardive dyskinesia, also found that showed significant decrease in negative symptoms. Additionally, tDCS is considered one of the safe office procedures with minimal and self-limiting side-effects viz. burning sensation, redness at electrode placement area, tingling sensation, itching and headache.

Despite multiple benefits of this non-invasive treatment modality, there is a huge research gap in this field. Hence, this study proposes to study the effect of adjuvant Cerebellar anodal tDCS on Negative Symptoms of Schizophrenia

 
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