Examining Neuroplasticity Modulation as Mechanistic Basis of tDCS Treatment Effects on Auditory Verbal Hallucination in Schizophrenia

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Schizophrenia is a severe neuropsychiatric disorder of the brain and is also one of the top ten disabling diseases. A common symptom of schizophrenia (SCZ) is hearing voices inside one's heads which others do not. Despite adequate medication, SCZ patients may continue to hear voices that are often rude or unfriendly and cause distress to the patients. Transcranial direct current stimulation (tDCS) is a safe, non-invasive brain stimulation technique that reduces 'hearing voices'. However, how and why add-on tDCS works is unclear. The brain can change itself in response to its environment; this is called neuroplasticity. tDCS possibly changes the brain's environment and/or enhances the brain's ability to respond favourably to its environment. This theory will be examined here by studying changes in brain functions before and after giving tDCS to schizophrenia patients hearing voices. The aim of this study is to examine the brain's neuroplasticity potential as the biological phenomena driving treatment effects of tDCS in Schizophrenia patients with clinically significant and persistent auditory verbal hallucinations. The secondary aims are to answer whether the brain's neuroplasticity potential in schizophrenia patients can predict their responsivity to tDCS treatment for auditory verbal hallucinations, and if chronicity of illness effects tDCS treatment response. The brain's neuroplasticity potential will be examined using neuroimaging and neurophysiological techniques that give information about the integrity of the brain's signal processing efficiency, the chemical concentration of certain bio-molecules within it, and how well different areas of the brain communicate with each other. With this information, the potential role of the brain's neuroplasticity potential in facilitating treatment effects of tDCS can be better understood. With this knowledge, it could be possible personalize tDCS treatment, profile tDCS responders and non-responders based on demographic and biological factors, and prescribe tDCS at the appropriate time within the illness course for maximal benefit to the SCZ patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• Diagnosis of schizophrenia or schizoaffective disorder as per DSM-5 (American Psychiatric Association, 2013)

• Clinically Significant Auditory Verbal Hallucinations

• Right-handedness

• Written informed consent

Locations
Other Locations
India
Department of Psychiatry, National Institute of Mental Health And Neuro Sciences (NIMHANS), Bengaluru, Karnataka
RECRUITING
Bengaluru
Contact Information
Primary
Anushree Bose, PhD
anushree.cp@gmail.com
+91-8026995366
Backup
Ganesan Venkatasubramanian, MD, PhD
gvs@nimhans.ac.in
+91-8026995366
Time Frame
Start Date: 2024-04-02
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 72
Treatments
Experimental: Verum Accelerated Transcranial Direct Current Stimulation (acctDCS)
Each SCZ patient will receive five sessions daily for two days, a 10-session course of tDCS \[anode: left-DLPFC (at F3) and cathode: left-TPJ (midway between C3 and P3); electrode size: 35cm2\]. For the Verum-tDCS condition, 2-mA of constant current will be delivered for 20 minutes, with additional ramp-up and ramp-down of 30 seconds each.
Placebo_comparator: Sham Accelerated Transcranial Direct Current Stimulation (tDCS)
Each SCZ patient will receive five sessions daily for two days, a 10-session course of tDCS \[anode: left-DLPFC (at F3) and cathode: left-TPJ (midway between C3 and P3); electrode size: 35cm2\]. For Sham-tDCS, no current will be delivered beyond the initial ramp-up time.
Related Therapeutic Areas
Sponsors
Leads: National Institute of Mental Health and Neuro Sciences, India

This content was sourced from clinicaltrials.gov