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Effect of brain stimulation on self related information processing in schizophrenia patients hearing medication incurable voices: A study of brain cognition, physiology and imaging related to the disease

â??Effect of Neuromodulation on Ipseity Encoding in Schizophrenia Patients with Persistent Auditory Hallucinations: Neurocognitive, Neurophysiological & Neuroimaging Studiesâ??

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050442
Enrollment
44
Registered
2023-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F20- Schizophrenia

Interventions

Intervention1: Transcranial Magnetic Stimulation and transcranial direct current stimulation: TMS INTERVENTION: 1. Continuous theta burst stimulation TMS OVER left TPJ at 120 percent of RMT. 600 pulse
cathode over left TPJ and anode over left DLPFC. 2mA of current with 20 seconds fade in fade out phase- will be delivered for 20 minutes. 2. 2 sessions will be delivered 3 hours apart. 3. Correspond

Sponsors

DBT/Wellcome Trust India Alliance (India Alliance)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Schizophrenia Diagnosis according to the DSM-5 2. Age 18-45 years; 3. Any sex; 4. Right-Handedness using Edinburgh Handedness Inventory 5. Persistence of auditory hallucinations without remission despite treatment with at least one antipsychotic medication at an adequate dose for a minimum duration of six weeks. (Non-remission is defined as a score of moderate or high ( >2) on the Global Rating of Hallucinations in the scale for the assessment of positive symptoms (SAPS) 6. Capacity to consent for research studies as per the assessment using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) 7. Ability to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Psychiatric emergency necessitating electroconvulsive therapy; 2. Suicidal risk / any psychiatric emergency; 3. Score of > 6 on Calgary Depression Rating Scale (Addington et al.,1994); 4. Pregnancy / Post-Partum; 5. substance use disorder in last six months (except caffeine ornicotine); 6. Co-morbid neurological / medical disease that can affect the brain structure / function. 7. Any Contraindication for Magnetic Resonance Imaging; 8. Any Contraindication for Transcranial Magnetic Stimulation. 9. Any Contraindication for Transcranial Direct Current Stimulation. 10. Hearing impairment 11. History of significant head injury (loss of consciousness more than30 minutes or any permanent sequelae)

Design outcomes

Primary

MeasureTime frame
To assess the neuromodulatory effect of cTBS and tDCS (Neuromodulation) on ipseity encoding(measured by DIFFERENCE OF N100 amplitude between talk and listen condition) and source monitoring deficit(P300 amplitude measured during source monitoring task) in patients with persistent auditory hallucination with schizophrenia via specific event related potential(ERP) parametersTimepoint: The effect will be determined by assessing the ERP parameters at 2 time points: before neuromodulation treatment and after 15 days of neuromodulation treatment.

Secondary

MeasureTime frame
1.To compare the ipseity monitoring ERPs in schizophrenia patients with medicationresistant persistent auditory hallucination with that of matched healthy control. 2. To compare the relative improvement of ipseity monitoring ERPs in schizophrenia patients with medication-resistant persistent auditory hallucination after cTBS TMS and tDCS intervention. 3.To evaluate the resting-state fMRI correlates of ipseity monitoring deficit and its change with NIBS intervention in patients of schizophrenia with medication-resistant persistent auditory hallucination. 4. To correlate the change in neurophysiological(ERPs) and neuroimaging (resting state fMRI) data evaluating ipseity monitoring deficit and itsimprovement with NIBS intervention with that of psychopathological variables assessing the severity of auditory hallucination in patients of schizophrenia with medication resistant persistent auditory hallucination.related potential studies.Timepoint: 2 time points: before intervention and after intervention

Countries

India

Contacts

Public ContactDr Subham Samantaray

Central Institute of Psychiatry, Ranchi

psynishant@gmail.com9431171162

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026