Effect of non invasive brain stimulation using direct current treatment on auditory hallucinations in schizophrenia

Completed

• Conditions: Schizophrenia

• Registration Number: CTRI/2018/02/012061
• Lead Sponsor: National Institute of Mental health and Neurosciences

Brief Summary

This study is a randomized double blinded, placebo controlled trial which will explore auditory hallucination; one of the most fundamental symptoms of schizophrenia, occurring in majority of the total schizophrenia patients of which about 20 - 30% might be unresponsive to medications. This study seeks to understand the neural correlates of persistent auditory verbal hallucinations in schizophrenia patients in comparison with healthy controls and also the changes in neural activity, before and after brain stimulation using add-on HD-tDCS technique (wherein low intensity weak direct currents act on cortical areas, thus facilitating or inhibiting spontaneous neuronal activity). This study will also be able to comment on the usefulness and efficacy of add-on HD-tDCS as a treatment modality for patients suffering from persistent auditory verbal hallucinations in schizophrenia.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-03
• Study Completion: 2019-10-28
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 1. Diagnosis of schizophrenia / schizophreniform disorder as per DSM criteria (Diagnostic and Statistical Manual for Mental Disorders, American Psychiatric Association); 2) Persistent auditory hallucination despite adequate antipsychotic medication (atleast one antipsychotic trial) with unchanged dose at least for the past 4 weeks.
• 3. Clinically Significant Auditory Verbal Hallucinations as defined by a structured rating scale for assessing auditory hallucination; 4) Age range: 18 – 45 years; 5) Both sexes; 6) Right Handedness and 7) Having satisfactory capacity to consent.
• 8. Written informed consent.

Exclusion Criteria

1. Features suggestive of psychiatric emergency (for example: suicidal risk, aggression, excitement, catatonia, prolonged nutritional deprivation or any other status requiring intensive clinical care), 2) Any contraindication to HD-tDCS procedure – (i) metal in the head, (ii) implanted brain medical devices, (iii) local lesion or injury in the scalp / head, 3) Any concurrent co-morbid psychiatric diagnosis; 4) Pregnancy or post-partum status; 5) Any contraindication for MRI; and 6) Left Handedness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Severity of auditory hallucinations.	Twice. First day (Day 0), before the treatment with HD-tDCS is given. And second on the last day(day 5), after the second session of HD-tDCS treatment is over.
2. Change in the neural correlates involved in auditory hallucinations(Using brain imaging techniques like structural MRI, resting fMRI and DTI)	Twice. First day (Day 0), before the treatment with HD-tDCS is given. And second on the last day(day 5), after the second session of HD-tDCS treatment is over.

Secondary Outcome Measures

Name	Time	Method
Severity of positive and negative symptoms	Twice. First day (Day 0), before the treatment with HD-tDCS is given. And second on the last day(day 5), after the second session of HD-tDCS treatment is over.

Trial Locations

Locations (1)

National Institute of Mental Health And Neurosciences (NIMHANS); 🇮🇳 Bangalore, KARNATAKA, India

National Institute of Mental Health And Neurosciences (NIMHANS)

🇮🇳Bangalore, KARNATAKA, India

Dr Rujuta Parlikar

Principal investigator

08425881284

rujuta@parlikar.com