Treatment of Refractory Auditory Verbal Hallucinations With tDCS in Schizophrenia

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Device: tDCS

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tDCS; Patients with schizophrenia to receive tDCS treatment	Device: tDCS; 2mA direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions; 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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jun Soo Kwon, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: May 18, 2015
• First Posted (Estimate): May 22, 2015

Study Record Updates

• Last Update Posted (Estimate): December 30, 2016
• Last Update Submitted That Met QC Criteria: December 28, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Schizophrenia; tDCS; Refractory auditory hallucination
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Perceptual Disorders; Schizophrenia; Hallucinations
• Other Study ID Numbers: 1501-022-638

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No