Ignite Creation Date:
2024-07-17 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494124
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-04-03
Brief Title:
Efficacy and Safety of tACS vs tDCS in Schizophrenia
Sponsor:
All India Institute of Medical Sciences Bhubaneswar
Organization:
All India Institute of Medical Sciences Bhubaneswar
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None