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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Diagnosis of Schizophrenia as per ICD-10 DCR for more than 2 years

• Moderate-severe symptoms (PANSS score \> 75 and/or CGI-SCH score\>4) \[24\]

• On stable dosing of antipsychotic medications (no changes in medication or doses for 1 month prior to enrolment)

• Both sexes; Age range: 18-60 years

• Right-handed

• Written informed consent by the patient

Locations
Other Locations
India
All India Institute of Medical Scinces - Bhubaneswar
RECRUITING
Bhubaneswar
Contact Information
Primary
Biswa R Mishra
brm1678@gmail.com
09438884220
Backup
Debadatta Mohapatra
psych_debadatta@aiimsbhubaneswar.edu.in
09438884221
Time Frame
Start Date: 2024-04-03
Estimated Completion Date: 2026-06
Participants
Target number of participants: 90
Treatments
Experimental: tACS group
10 Hz 2 mA peak-to-peak stimulation will be for 20 minutes, at zero-degree phase difference and zero offset current
Active_comparator: tDCS group
tDCS stimulation: 2 mA stimulation will be applied for 20 minutes
Sham_comparator: sham controlled group
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
Related Therapeutic Areas
Sponsors
Collaborators: Indian Council of Medical Research
Leads: All India Institute of Medical Sciences, Bhubaneswar

This content was sourced from clinicaltrials.gov