Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Indian Council of Medical Research | OTHER_GOV |
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| tDCS group | Active Comparator | tDCS stimulation: 2 mA stimulation will be applied for 20 minutes |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) | Measures psychopathology and illness severity in schizophrenia | Baseline, Day 5, Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Auditory Hallucination Rating Scale (AHRS) | Measures severity of auditory hallucinations in schizophrenia | Baseline, Day 5, Day 10 |
| Brief Cognitive Assessment Tool for Schizophrenia (B-CATS) | Measures neurocognitive deficits in schizophrenia |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Biswa R Mishra | Contact | 09438884220 | brm1678@gmail.com | |
| Debadatta Mohapatra | Contact | 09438884221 | psych_debadatta@aiimsbhubaneswar.edu.in |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All India Institute of Medical Scinces - Bhubaneswar | Recruiting | Bhubaneswar | Odisha | 751019 | India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
|
| 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). |
|
| Baseline, Day 5, Day 10 |
| Global Assessment of Functioning (GAF) | Measures overall functioning of the patients with mental illness including schizophrenia | Baseline, Day 5, Day 10 |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |