| CTRI Number |
CTRI/2025/10/096326 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECTIVENESS OF TRANSCRANIAL DIRECT CURRENT STIMULATION OF BRAIN IN COGNITION IN PATIENTS OF SCHIZOPHRENIA
DISORDER. |
|
Scientific Title of Study
|
Efficacy and safety of extended high-definition transcranial direct current stimulation (hd- tdcs) in enhancing cognitive function in schizophrenia: a randomized, double-blind, 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 |
Dr Mohan Dhyani |
| Designation |
Head Of Department and Professor |
| Affiliation |
Sri Guru Ram Rai Institute Of Medical and Health Sciences |
| Address |
Room No. 91, South Block, Department of Psychiatry, Sri Guru Ram
Rai Institute of Medical and Health Sciences, Patel Nagar,
Dehradun, Uttarakhand 248001 India
Dehradun
UTTARANCHAL
248001
India
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9997688192 |
| Fax |
|
| Email |
dhyani.mohan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan Dhyani |
| Designation |
Head Of Department and Professor |
| Affiliation |
Sri Guru Ram Rai Institute Of Medical and Health Sciences |
| Address |
Room No. 91, South Block, Department of Psychiatry, Sri Guru Ram
Rai Institute of Medical and Health Sciences, Patel Nagar,
Dehradun, Uttarakhand 248001 India
Dehradun
UTTARANCHAL
248001
India
UTTARANCHAL
248001
India |
| Phone |
9997688192 |
| Fax |
|
| Email |
dhyani.mohan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhruv Khanna |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Sri Guru Ram Rai Institute Of Medical and Health Sciences |
| Address |
Room no 209, shiva apartment, patel nagar, dehradun, uttarakhand, 248001
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8219386692 |
| Fax |
|
| Email |
dhruvkhanna195@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ram
Rai Institute of Medical and Health Sciences, Patel Nagar,
Dehradun, Uttarakhand 248001 India |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Rai Institute of Medical and Health Sciences |
| Address |
SGRRIMHS (Sri Guru Ram Rai Institute of Medical and Health
Sciences), Patel Nagar, Dehradun, 248001 |
| Type of Sponsor |
Private 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 |
| Dhruv Khanna |
Shri Mahant Indiresh Hospital |
Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences (SGRRIM&HS), Dehradun, Uttarakhand, India.
Dehradun
UTTARANCHAL |
8219386692
dhruvkhanna195@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F200||Paranoid schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High-definition transcranial direct current stimulation (HD- tDCS) |
20 sessions (2 sessions per day, 45 minutes apart, 5 days/week for 2 weeks), administered in a controlled clinical setting.
Total duration of study willbe 18 months |
| Comparator Agent |
High-definition transcranial direct current stimulation (HD- tDCS) |
High-definition transcranial direct current stimulation (HD- tDCS) is a non-invasive neuromodulation technique that alters neuronal excitability by delivering low-intensity direct currents via scalp electrodes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Provided written informed consent.
2. Diagnosis of schizophrenia as per (DSM-5 criteria).
3. Age: 18–50 years.
4. Patient should be stable on same antipsychotic medication.
5. Hindi MOCA score of less than 26.
|
|
| ExclusionCriteria |
| Details |
1.History of seizures or neurological disorders.
2. Patients with implanted metallic devices
3. Substance dependence (except nicotine or caffeine) in the past 6 months.
4. Any other major mental disorders.
5. Patient is uncooperative for the procedure.
6. Patients with neurological disorders with history of epilepsy, organic brain damage or any neurological procedures
7. Patients with significant unstable medical conditions like uncontrolled hypertension, complicated diabetes mellitus, organic failures, etc.
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Hindi MoCA and SCoRS scores across T0, T1, and T2.
Analysis: Mixed-effects repeated-measures ANOVA with group (active vs. sham) as the between-subjects factor and time (T0, T1, T2) as the within-subjects factor, conducted separately for MoCA and SCoRS. |
baseline, 15 days, 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in PANSS, WHO-QOL, & CGI-S scores.
|
baseline, 15 days, 30 days |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
01/11/2025 |
| 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 Applicable |
| 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
|
Schizophrenia is a chronic, disabling psychiatric disorder that affects approximately 20 million people worldwide. It is characterized by positive symptoms (hallucinations, delusions), negative symptoms (emotional flattening, social withdrawal), and notably, cognitive impairments. These cognitive deficits—particularly in attention, working memory, executive function, and processing speed—are increasingly recognized as core features of the disorder. Unlike positive symptoms, cognitive dysfunction typically predates psychosis and persists throughout the illness Despite advancements in pharmacotherapy, especially with second-generation antipsychotics, medications offer limited efficacy for cognitive improvement. This highlights an urgent need for adjunctive non-pharmacological interventions. High-definition transcranial direct current stimulation (HD- tDCS) is a non-invasive neuromodulation technique that alters neuronal excitability by delivering low-intensity direct currents via scalp electrodes. Anodal stimulation enhances excitability, while cathodal stimulation reduces it. HD- tDCS is portable, low-cost, well-tolerated, and has shown promise for enhancing cognitive domains like working memory and executive functioning in schizophrenia. When targeted at the left dorsolateral prefrontal cortex (DLPFC), HD- tDCS has demonstrated measurable cognitive benefits. This study aims to investigate the effectiveness of HD- tDCS as a tool for cognitive enhancement in patients with schizophrenia, particularly in improving working memory, attention, and executive function.
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