Treatment of Refractory Auditory Verbal Hallucinations With tDCS in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to exploratively evaluate the efficacy and safety of transcranial direct current stimulation (tDCS) in patients with schizophrenia who experience persistent auditory verbal hallucinations after adequate antipsychotics therapy for over three months.

Official Title
-----------------
A Pilot Study for the Treatment of Refractory Auditory Verbal Hallucinations With Transcranial Direct Current Stimulation(tDCS) in Patients With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Device: tDCS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with schizophrenia by the Diagnostic and Statistical Manual of Mental Disorders, Fourth edition, Text Revision (DSM-IV-TR) Presence of auditory hallucination after three months' trial of antipsychotics of adequate dose The Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) score is at least 8 Exclusion Criteria: Significant brain pathology including head trauma, seizure, meningitis Intellectual disability (IQ < 70) Severe personality disorder Substance use disorder (except nicotine) Severe medical illness Disability in the sensory organs Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS<br>Patients with schizophrenia to receive tDCS treatment | Device: tDCS<br>* 2mA direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions<br>* Other names: YDT-201N;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Auditory hallucination change by changes in The Psychotic Symptom Rating Scales (PSYRATs) Auditory hallucinations subscale score | Auditory hallucination change by changes in the auditory hallucinations subscale from the Psychotic Symptom Rating Scales | approximately 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electroencephalography - resting | change in lagged phase synchronization value change in microstate connectivity value | approximately 2 weeks | 
| Electroencephalography - P300 peak | change in P300 peak amplitude during auditory oddball task change in P300 peak latency during auditory oddball task | approximately 2 weeks | 
| Electroencephalography - P300 source | change in P300 source strength during auditory oddball task change in P300 source location during auditory oddball task | approximately 2 weeks | 
| Electroencephalography - P50 | change in T/C ratio (testing stimulus/conditioning stimulus) during paired click test change in T/C difference (conditioning stimulus-testing stimulus) during paired click test change in T/C difference (testing stimulus - conditioning stimulus) during paired click test | approximately 2 weeks | 
| Electroencephalography - ERN (error-related negativity) peak | change in ERN peak amplitude during flanker task change in ERN peak latency during flanker task | approximately 2 weeks | 
| Electroencephalography - ERN (error-related negativity) source | change in ERN source strength during flanker task change in ERN source location during flanker task | approximately 2 weeks | 
| Electroencephalography - ERN (error-related negativity) frequency activity | change in ERN beta band activity during flanker task change in ERN theta band activity during flanker task change in ERN delta band activity during flanker task | approximately 2 weeks | 
| Brain Magnetic Resonance Image (MRI) - T1 Image grey matter thickness | change in grey matter thickness | approximately 2 weeks | 
| Brain Magnetic Resonance Image (MRI) - T1 Image grey matter volume | change in grey matter volume | approximately 2 weeks | 
| Brain MRI - functional MRI | change in Pearson's correlation coefficient of BOLD signals | approximately 2 weeks | 
| Brain MRI - Diffusion Tensor Image (DTI) functional anisotropy | change in fractional anisotropy | approximately 2 weeks | 
| Brain MRI - Diffusion Tensor Image (DTI) mean diffusivity | change in mean diffusivity | approximately 2 weeks | 
| Brain MRI - Diffusion Tensor Image (DTI) radial diffusivity | change in radial diffusivity | approximately 2 weeks | 
| Brain MRI - Diffusion Tensor Image (DTI) axial diffusivity | change in axial diffusivity | approximately 2 weeks | 
| Brain MRI - myelin image | change in myelin imaging intensity value | approximately 2 weeks | 
| Kicer values change with treatment in striatum assessed by 18F-DOPA Positron Emission Tomography (PET) | - Kicer values change with treatment in striatum | approximately 2 weeks | 
| Magnetic Resonance Spectroscopy (MRS) | - N-Acetyl Aspartate, Creatin, Choline, Myoinositol, Glutamate, Glutamine, GABA metabolite concentration change with treatment | approximately 2 weeks | 
| Auditory hallucination change by changes in the Auditory Hallucination Rating Scale (AHRS) score | Auditory hallucination change by changes in the Auditory Hallucination Rating Scale score | approximately 2 weeks | 
| Auditory hallucination change by changes in the Korean Version of Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) score | Auditory hallucination change by changes in the Korean Version of Hamilton Program for Schizophrenia Voices Questionnaire score | approximately 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Refractory auditory hallucination, tDCS