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Treatment of Refractory Auditory Verbal Hallucinations With tDCS in Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
tDCS
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Refractory auditory hallucination, tDCS

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tDCS

Arm Description

Patients with schizophrenia to receive tDCS treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Electroencephalography - resting
change in lagged phase synchronization value change in microstate connectivity value
Electroencephalography - P300 peak
change in P300 peak amplitude during auditory oddball task change in P300 peak latency during auditory oddball task
Electroencephalography - P300 source
change in P300 source strength during auditory oddball task change in P300 source location during auditory oddball task
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
Electroencephalography - ERN (error-related negativity) peak
change in ERN peak amplitude during flanker task change in ERN peak latency during flanker task
Electroencephalography - ERN (error-related negativity) source
change in ERN source strength during flanker task change in ERN source location during flanker task
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
Brain Magnetic Resonance Image (MRI) - T1 Image grey matter thickness
change in grey matter thickness
Brain Magnetic Resonance Image (MRI) - T1 Image grey matter volume
change in grey matter volume
Brain MRI - functional MRI
change in Pearson's correlation coefficient of BOLD signals
Brain MRI - Diffusion Tensor Image (DTI) functional anisotropy
change in fractional anisotropy
Brain MRI - Diffusion Tensor Image (DTI) mean diffusivity
change in mean diffusivity
Brain MRI - Diffusion Tensor Image (DTI) radial diffusivity
change in radial diffusivity
Brain MRI - Diffusion Tensor Image (DTI) axial diffusivity
change in axial diffusivity
Brain MRI - myelin image
change in myelin imaging intensity value
Kicer values change with treatment in striatum assessed by 18F-DOPA Positron Emission Tomography (PET)
- Kicer values change with treatment in striatum
Magnetic Resonance Spectroscopy (MRS)
- N-Acetyl Aspartate, Creatin, Choline, Myoinositol, Glutamate, Glutamine, GABA metabolite concentration change with treatment
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
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

Full Information

First Posted
April 27, 2015
Last Updated
December 28, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02451371
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Refractory auditory hallucination, tDCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS
Arm Type
Experimental
Arm Description
Patients with schizophrenia to receive tDCS treatment
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
YDT-201N
Intervention Description
2mA direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions
Primary Outcome Measure Information:
Title
Auditory hallucination change by changes in The Psychotic Symptom Rating Scales (PSYRATs) Auditory hallucinations subscale score
Description
Auditory hallucination change by changes in the auditory hallucinations subscale from the Psychotic Symptom Rating Scales
Time Frame
approximately 2 weeks
Secondary Outcome Measure Information:
Title
Electroencephalography - resting
Description
change in lagged phase synchronization value change in microstate connectivity value
Time Frame
approximately 2 weeks
Title
Electroencephalography - P300 peak
Description
change in P300 peak amplitude during auditory oddball task change in P300 peak latency during auditory oddball task
Time Frame
approximately 2 weeks
Title
Electroencephalography - P300 source
Description
change in P300 source strength during auditory oddball task change in P300 source location during auditory oddball task
Time Frame
approximately 2 weeks
Title
Electroencephalography - P50
Description
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
Time Frame
approximately 2 weeks
Title
Electroencephalography - ERN (error-related negativity) peak
Description
change in ERN peak amplitude during flanker task change in ERN peak latency during flanker task
Time Frame
approximately 2 weeks
Title
Electroencephalography - ERN (error-related negativity) source
Description
change in ERN source strength during flanker task change in ERN source location during flanker task
Time Frame
approximately 2 weeks
Title
Electroencephalography - ERN (error-related negativity) frequency activity
Description
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
Time Frame
approximately 2 weeks
Title
Brain Magnetic Resonance Image (MRI) - T1 Image grey matter thickness
Description
change in grey matter thickness
Time Frame
approximately 2 weeks
Title
Brain Magnetic Resonance Image (MRI) - T1 Image grey matter volume
Description
change in grey matter volume
Time Frame
approximately 2 weeks
Title
Brain MRI - functional MRI
Description
change in Pearson's correlation coefficient of BOLD signals
Time Frame
approximately 2 weeks
Title
Brain MRI - Diffusion Tensor Image (DTI) functional anisotropy
Description
change in fractional anisotropy
Time Frame
approximately 2 weeks
Title
Brain MRI - Diffusion Tensor Image (DTI) mean diffusivity
Description
change in mean diffusivity
Time Frame
approximately 2 weeks
Title
Brain MRI - Diffusion Tensor Image (DTI) radial diffusivity
Description
change in radial diffusivity
Time Frame
approximately 2 weeks
Title
Brain MRI - Diffusion Tensor Image (DTI) axial diffusivity
Description
change in axial diffusivity
Time Frame
approximately 2 weeks
Title
Brain MRI - myelin image
Description
change in myelin imaging intensity value
Time Frame
approximately 2 weeks
Title
Kicer values change with treatment in striatum assessed by 18F-DOPA Positron Emission Tomography (PET)
Description
- Kicer values change with treatment in striatum
Time Frame
approximately 2 weeks
Title
Magnetic Resonance Spectroscopy (MRS)
Description
- N-Acetyl Aspartate, Creatin, Choline, Myoinositol, Glutamate, Glutamine, GABA metabolite concentration change with treatment
Time Frame
approximately 2 weeks
Title
Auditory hallucination change by changes in the Auditory Hallucination Rating Scale (AHRS) score
Description
Auditory hallucination change by changes in the Auditory Hallucination Rating Scale score
Time Frame
approximately 2 weeks
Title
Auditory hallucination change by changes in the Korean Version of Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) score
Description
Auditory hallucination change by changes in the Korean Version of Hamilton Program for Schizophrenia Voices Questionnaire score
Time Frame
approximately 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Soo Kwon, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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Treatment of Refractory Auditory Verbal Hallucinations With tDCS in Schizophrenia

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