Efficacy and Safety of tACS vs tDCS in Schizophrenia
ConditionSchizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAll India Institute of Medical Sciences, Bhubaneswar
About this 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
transcranial Alternating current stimulation (tACS)
DeviceIt 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)
DeviceIt 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
Device1mA 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).
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: tACS groupExperimental treatment 1 intervention
Group B: tDCS groupActive comparator 1 intervention
Group C: sham controlled groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Positive and Negative Syndrome Scale (PANSS)
Measures psychopathology and illness severity in schizophrenia
Time frame
Baseline, Day 5, Day 10Secondary outcomes
1
Auditory Hallucination Rating Scale (AHRS)
Measures severity of auditory hallucinations in schizophrenia
Time frame
Baseline, Day 5, Day 102
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
Measures neurocognitive deficits in schizophrenia
Time frame
Baseline, Day 5, Day 103
Global Assessment of Functioning (GAF)
Measures overall functioning of the patients with mental illness including schizophrenia
Time frame
Baseline, Day 5, Day 10Sponsors and contacts
Click on the lead sponsor to view all of their trials.
All India Institute of Medical Sciences, Bhubaneswar
Lead sponsor
Indian Council of Medical Research
Collaborator
Source ClinicalTrials.gov