Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2024-04-03
2026-06-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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tACS group
10 Hz 2 mA peak-to-peak stimulation will be for 20 minutes, at zero-degree phase difference and zero offset current
transcranial Alternating current stimulation (tACS)
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.
tDCS group
tDCS stimulation: 2 mA stimulation will be applied for 20 minutes
transcranial Direct current stimulation (tDCS)
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 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
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. 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).
Interventions
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transcranial Alternating current stimulation (tACS)
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)
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
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).
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
60 Years
ALL
No
Sponsors
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Indian Council of Medical Research
OTHER_GOV
All India Institute of Medical Sciences, Bhubaneswar
OTHER
Responsible Party
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BISWA RANJAN MISHRA
Additional Professor
Locations
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All India Institute of Medical Scinces - Bhubaneswar
Bhubaneswar, Odisha, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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T/EMF/Psych/21/67
Identifier Type: -
Identifier Source: org_study_id
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