Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06494124

Efficacy and Safety of tACS vs tDCS in Schizophrenia

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

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).

Primary outcomes

  1. Positive and Negative Syndrome Scale (PANSS)

    Time frame: Baseline, Day 5, Day 10

    Measures psychopathology and illness severity in schizophrenia

Secondary outcomes

  1. Auditory Hallucination Rating Scale (AHRS)

    Time frame: Baseline, Day 5, Day 10

    Measures severity of auditory hallucinations in schizophrenia

  2. Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)

    Time frame: Baseline, Day 5, Day 10

    Measures neurocognitive deficits in schizophrenia

  3. Global Assessment of Functioning (GAF)

    Time frame: Baseline, Day 5, Day 10

    Measures overall functioning of the patients with mental illness including schizophrenia

Study contacts

Contact information is provided by the study sponsor or research team.

Biswa R Mishra

CONTACT

[email protected]

09438884220

Debadatta Mohapatra

CONTACT

[email protected]

09438884221

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Collaborators

  • Indian Council of Medical Research

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.