Clinical trial NCT02451371: Treatment of Refractory Auditory Verbal Hallucinations With tDCS in Schizophrenia
Official title: A Pilot Study for the Treatment of Refractory Auditory Verbal Hallucinations With Transcranial Direct Current Stimulation(tDCS) in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Refractory auditory hallucination
tDCS
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-05-22
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Auditory hallucination change by changes in The Psychotic Symptom Rating Scales (PSYRATs) Auditory hallucinations subscale score
timeFrame: approximately 2 weeks
Secondary outcomes:
measure: Electroencephalography - resting
timeFrame: approximately 2 weeks
measure: Electroencephalography - P300 peak
timeFrame: approximately 2 weeks
measure: Electroencephalography - P300 source
timeFrame: approximately 2 weeks
measure: Electroencephalography - P50
timeFrame: approximately 2 weeks
measure: Electroencephalography - ERN (error-related negativity) peak
timeFrame: approximately 2 weeks
measure: Electroencephalography - ERN (error-related negativity) source
timeFrame: approximately 2 weeks
measure: Electroencephalography - ERN (error-related negativity) frequency activity
timeFrame: approximately 2 weeks
measure: Brain Magnetic Resonance Image (MRI) - T1 Image grey matter thickness
timeFrame: approximately 2 weeks
measure: Brain Magnetic Resonance Image (MRI) - T1 Image grey matter volume
timeFrame: approximately 2 weeks
measure: Brain MRI - functional MRI
timeFrame: approximately 2 weeks
measure: Brain MRI - Diffusion Tensor Image (DTI) functional anisotropy
timeFrame: approximately 2 weeks
measure: Brain MRI - Diffusion Tensor Image (DTI) mean diffusivity
timeFrame: approximately 2 weeks
measure: Brain MRI - Diffusion Tensor Image (DTI) radial diffusivity
timeFrame: approximately 2 weeks
measure: Brain MRI - Diffusion Tensor Image (DTI) axial diffusivity
timeFrame: approximately 2 weeks
measure: Brain MRI - myelin image
timeFrame: approximately 2 weeks
measure: Kicer values change with treatment in striatum assessed by 18F-DOPA Positron Emission Tomography (PET)
timeFrame: approximately 2 weeks
measure: Magnetic Resonance Spectroscopy (MRS)
timeFrame: approximately 2 weeks
measure: Auditory hallucination change by changes in the Auditory Hallucination Rating Scale (AHRS) score
timeFrame: approximately 2 weeks
measure: Auditory hallucination change by changes in the Korean Version of Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) score
timeFrame: approximately 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jun Soo Kwon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: