RECRUITINGINTERVENTIONAL

Efficacy and Safety of tACS vs tDCS in Schizophrenia

Comparison of Efficacy and Safety of Transcranial Alternating Current Stimulation vs Transcranial Direct Current Stimulation on Psychopathology Measures and Neurocognition in Chronic Schizophrenia: A Randomized Double-blind Controlled Trial

About This Trial

This clinical trial aims to compare the efficacy and safety of transcranial Alternating current stimulation (tACS) vs. transcranial Direct current stimulation (tDCS) vs. sham stimulation in chronic schizophrenia. The main question it aims to answer is: • In comparison to tDCS, can tACS improve the clinical outcome of patients with chronic schizophrenia? Participants will be randomised into 3 groups receiving either tDCS, tACS or sham stimulation and changes in psychopathology and neuro-cognition with the interventions will be compared within and between the groups. The primary outcome measure is the Positive and Negative Syndrome Scale (PANSS), while secondary outcome measures are the Auditory Hallucination Rating Scale (AHRS), Brief Cognitive Assessment Tool for Schizophrenia (B-CATS), and Global Assessment of Functioning (GAF).

Who May Be Eligible (Plain English)

Who May Qualify: 1. Diagnosis of Schizophrenia as per ICD-10 DCR for more than 2 years 2. Moderate-severe symptoms (PANSS score \> 75 and/or CGI-SCH score\>4) \[24\] 3. On stable dosing of antipsychotic medications (no changes in medication or doses for 1 month prior to enrolment) 4. Both sexes; Age range: 18-60 years 5. Right-handed 6. Written willing to sign a consent form by the patient Who Should NOT Join This Trial: 1. Features suggestive of psychiatric emergency (for example: suicidal risk, catatonia, prolonged nutritional deprivation) or others (for example: aggression or excitement) 2. Any contraindication to tDCS procedure: Metal in the head, Implanted brain medical devices, Local lesion or injury in the scalp / head 3. Co-morbid neurological disease 4. Left Handed Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Diagnosis of Schizophrenia as per ICD-10 DCR for more than 2 years 2. Moderate-severe symptoms (PANSS score \> 75 and/or CGI-SCH score\>4) \[24\] 3. On stable dosing of antipsychotic medications (no changes in medication or doses for 1 month prior to enrolment) 4. Both sexes; Age range: 18-60 years 5. Right-handed 6. Written informed consent by the patient Exclusion Criteria: 1. Features suggestive of psychiatric emergency (for example: suicidal risk, catatonia, prolonged nutritional deprivation) or others (for example: aggression or excitement) 2. Any contraindication to tDCS procedure: Metal in the head, Implanted brain medical devices, Local lesion or injury in the scalp / head 3. Co-morbid neurological disease 4. Left Handed

Treatments Being Tested

DEVICE

transcranial Alternating current stimulation (tACS)

It is a non-invasive brain stimulation technique that uses small, pulsed alternating current (1mA) to modulate lasting cortical excitability, producing facilitatory or inhibitory effects upon a variety of behaviours, with proven efficacy in various neuropsychiatric disorders.

DEVICE

transcranial Direct current stimulation (tDCS)

It is a non-invasive brain stimulation technique that uses constant, low direct current to modulate lasting cortical excitability, producing facilitatory or inhibitory effects upon a variety of behaviours, with proven efficacy in various neuropsychiatric disorders.

DEVICE

Sham controlled

1mA current will be applied for the first 30 seconds to provide the initial sensation of real stimulation, and then the current will be stopped, thus minimizing the stimulatory effects. It is known to have no effect on psychopathology/neuro-cognition and means to mimic the tDCS/tACS (in order to help blinding of the participants).

Locations (1)

All India Institute of Medical Scinces - Bhubaneswar

Bhubaneswar, Odisha, India