Schizophrenia
Conditions
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.
Interventions
DEVICEtranscranial 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.
DEVICEtranscranial 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.
DEVICESham 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).
Sponsors
Indian Council of Medical Research
All India Institute of Medical Sciences, Bhubaneswar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) | Baseline, Day 5, Day 10 | Measures psychopathology and illness severity in schizophrenia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
India
Contacts
Primary ContactBiswa R Mishra
Backup ContactDebadatta Mohapatra
Outcome results
None listed