Efficacy and Safety of tACS vs tDCS in Schizophrenia

Not Applicable

Recruiting

• Conditions: Schizophrenia
• Interventions: Device: transcranial Direct current stimulation (tDCS); Device: transcranial Alternating current stimulation (tACS); Device: Sham controlled

• Registration Number: NCT06494124
• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar

Brief 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).

Detailed Description

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.

Study Timeline

• Study Start: 2024-04-03
• Study First Submitted: 2024-04-03
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Study First Posted: 2024-07-10
• Last Update Posted: 2024-07-10
• Primary Completion: 2026-04
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tDCS group	transcranial Direct current stimulation (tDCS)	tDCS stimulation: 2 mA stimulation will be applied for 20 minutes
tACS group	transcranial Alternating current stimulation (tACS)	10 Hz 2 mA peak-to-peak stimulation will be for 20 minutes, at zero-degree phase difference and zero offset current
sham controlled group	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

Primary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS)	Baseline, Day 5, Day 10	Measures psychopathology and illness severity in schizophrenia

Secondary Outcome Measures

Name	Time	Method
Auditory Hallucination Rating Scale (AHRS)	Baseline, Day 5, Day 10	Measures severity of auditory hallucinations in schizophrenia
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)	Baseline, Day 5, Day 10	Measures neurocognitive deficits in schizophrenia
Global Assessment of Functioning (GAF)	Baseline, Day 5, Day 10	Measures overall functioning of the patients with mental illness including schizophrenia

Trial Locations

Locations (1)

All India Institute of Medical Scinces - Bhubaneswar; 🇮🇳 Bhubaneswar, Odisha, India