Efficacy and Safety of tACS vs tDCS in Schizophrenia

NCT06494124 | Recruiting

• 1 other identifier: T/EMF/Psych/21/67
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Syndrome Scale (PANSS)

  Measures psychopathology and illness severity in schizophrenia

  Baseline, Day 5, Day 10

Secondary Outcomes (3)

• Auditory Hallucination Rating Scale (AHRS)

  Baseline, Day 5, Day 10

• Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)

  Baseline, Day 5, Day 10

• Global Assessment of Functioning (GAF)

  Baseline, Day 5, Day 10

Study Arms (3)

tACS group

EXPERIMENTAL

10 Hz 2 mA peak-to-peak stimulation will be for 20 minutes, at zero-degree phase difference and zero offset current

Device: transcranial Alternating current stimulation (tACS)

tDCS group

ACTIVE COMPARATOR

tDCS stimulation: 2 mA stimulation will be applied for 20 minutes

Device: transcranial Direct current stimulation (tDCS)

sham controlled group

SHAM COMPARATOR

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

Device: Sham controlled

Interventions

transcranial Alternating current stimulation (tACS) DEVICE

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.

tACS group

transcranial Direct current stimulation (tDCS) DEVICE

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.

tDCS group

Sham controlled DEVICE

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).

sham controlled group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Features suggestive of psychiatric emergency (for example: suicidal risk, catatonia, prolonged nutritional deprivation) or others (for example: aggression or excitement)
• Any contraindication to tDCS procedure: Metal in the head, Implanted brain medical devices, Local lesion or injury in the scalp / head
• Co-morbid neurological disease
• Left Handed

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead
• Indian Council of Medical Research: collaborator

Study Sites (1)

All India Institute of Medical Scinces - Bhubaneswar

Bhubaneswar, Odisha, 751019, India

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Biswa R Mishra

CONTACT

09438884220; brm1678@gmail.com

Debadatta Mohapatra

CONTACT

09438884221; psych_debadatta@aiimsbhubaneswar.edu.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Model Details: The intervention arms are Experimental (tACS), Active comparator (tDCS) and control comparator (sham). The patients in all 3 arms will continue to receive the ongoing antipsychotics.

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: July 10, 2024
• Study Start: April 3, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)