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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
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).
The proposed double-blind RCT will be conducted over 3 years involving 2 centres among patients with chronic schizophrenia (moderate-severe symptoms) of either gender, aged between 18 and 60. Those with any psychiatric emergency or contraindications for tDCS will be excluded. At baseline, PANSS will be administered to assess the severity of symptom dimension, AHRS for auditory hallucinations, B-CATS for neurocognitive deficits and GAF for global functionality. Patients will be randomized equally to 3 treatment groups: tACS, tDCS, or sham stimulation (30 in each group). The intervention will involve Cathodal stimulation of left TPJ and Anodal stimulation of left DLPFC. The transcranial brain stimulations: tACS, tDCS, or sham stimulation, will be given 2 sessions per day for 10 days. Following the 5th day and after the last treatment session, PANSS, AHRS, B-CATS, and GAF will be readministered to observe for the changes in the various outcome parameters. Any new treatment-emergent serious adverse effect will be recorded.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
All India Institute of Medical Scinces - Bhubaneswar
Bhubaneswar, Odisha, India
Start Date
April 3, 2024
Primary Completion Date
April 1, 2026
Completion Date
June 1, 2026
Last Updated
July 10, 2024
90
ESTIMATED participants
transcranial Alternating current stimulation (tACS)
DEVICE
transcranial Direct current stimulation (tDCS)
DEVICE
Sham controlled
DEVICE
Lead Sponsor
All India Institute of Medical Sciences, Bhubaneswar
Collaborators
NCT07455929
NCT06740383
Data Source & Attribution
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