| 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 |
|
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Source of Monetary or Material Support
|
|
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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
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Armed Forces Medical College, Pune |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F205||Residual schizophrenia, |
|
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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 |
|
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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 |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| effect of adjunctive Cerebellar anodal tDCS on Negative Symptoms |
End of fifth session |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Association between duration of illness & improvement in negative symptoms after adjuvant cerebellar anodal tDCS |
End of fifth session |
|
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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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- 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.
- 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.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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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 |