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Treatment of Refractory Auditory Verbal Hallucinations With tDCS in Schizophrenia

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ClinicalTrials.gov Identifier: NCT02451371
Recruitment Status : Completed
First Posted : May 22, 2015
Last Update Posted : December 30, 2016
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE April 27, 2015
First Posted Date  ICMJE May 22, 2015
Last Update Posted Date December 30, 2016
Study Start Date  ICMJE August 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2015)
Auditory hallucination change by changes in The Psychotic Symptom Rating Scales (PSYRATs) Auditory hallucinations subscale score [ Time Frame: approximately 2 weeks ]
Auditory hallucination change by changes in the auditory hallucinations subscale from the Psychotic Symptom Rating Scales
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02451371 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2015)
  • Electroencephalography - resting [ Time Frame: approximately 2 weeks ]
    • change in lagged phase synchronization value
    • change in microstate connectivity value
  • Electroencephalography - P300 peak [ Time Frame: approximately 2 weeks ]
    • change in P300 peak amplitude during auditory oddball task
    • change in P300 peak latency during auditory oddball task
  • Electroencephalography - P300 source [ Time Frame: approximately 2 weeks ]
    • change in P300 source strength during auditory oddball task
    • change in P300 source location during auditory oddball task
  • Electroencephalography - P50 [ Time Frame: approximately 2 weeks ]
    • 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 [ Time Frame: approximately 2 weeks ]
    • change in ERN peak amplitude during flanker task
    • change in ERN peak latency during flanker task
  • Electroencephalography - ERN (error-related negativity) source [ Time Frame: approximately 2 weeks ]
    • change in ERN source strength during flanker task
    • change in ERN source location during flanker task
  • Electroencephalography - ERN (error-related negativity) frequency activity [ Time Frame: approximately 2 weeks ]
    • 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 [ Time Frame: approximately 2 weeks ]
    change in grey matter thickness
  • Brain Magnetic Resonance Image (MRI) - T1 Image grey matter volume [ Time Frame: approximately 2 weeks ]
    change in grey matter volume
  • Brain MRI - functional MRI [ Time Frame: approximately 2 weeks ]
    change in Pearson's correlation coefficient of BOLD signals
  • Brain MRI - Diffusion Tensor Image (DTI) functional anisotropy [ Time Frame: approximately 2 weeks ]
    change in fractional anisotropy
  • Brain MRI - Diffusion Tensor Image (DTI) mean diffusivity [ Time Frame: approximately 2 weeks ]
    change in mean diffusivity
  • Brain MRI - Diffusion Tensor Image (DTI) radial diffusivity [ Time Frame: approximately 2 weeks ]
    change in radial diffusivity
  • Brain MRI - Diffusion Tensor Image (DTI) axial diffusivity [ Time Frame: approximately 2 weeks ]
    change in axial diffusivity
  • Brain MRI - myelin image [ Time Frame: approximately 2 weeks ]
    change in myelin imaging intensity value
  • Kicer values change with treatment in striatum assessed by 18F-DOPA Positron Emission Tomography (PET) [ Time Frame: approximately 2 weeks ]
    - Kicer values change with treatment in striatum
  • Magnetic Resonance Spectroscopy (MRS) [ Time Frame: approximately 2 weeks ]
    - 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 [ Time Frame: approximately 2 weeks ]
    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 [ Time Frame: approximately 2 weeks ]
    Auditory hallucination change by changes in the Korean Version of Hamilton Program for Schizophrenia Voices Questionnaire score
Original Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2015)
  • Electroencephalography - resting [ Time Frame: approximately 2 weeks ]
    change in lagged phase synchronization value
  • Electroencephalography - P300 peak amplitude [ Time Frame: approximately 2 weeks ]
    change in P300 peak amplitude during auditory oddball task
    • T/C ratio(testing stimulus/conditioning stimulus)
    • T/C difference(testing stimulus - conditioning stimulus)
  • Electroencephalography - P300 peak latency [ Time Frame: approximately 2 weeks ]
    change in P300 peak latency during auditory oddball task
    • T/C ratio(testing stimulus/conditioning stimulus)
    • T/C difference(testing stimulus - conditioning stimulus)
  • Electroencephalography - P50 [ Time Frame: approximately 2 weeks ]
    • change in T/C ratio (testing stimulus/conditioning stimulus) during paired click test
    • change in T/C difference (testing stimulus - conditioning stimulus) during paired click test
  • Brain Magnetic Resonance Image (MRI) - T1 Image grey matter thickness [ Time Frame: approximately 2 weeks ]
    change in grey matter thickness
  • Brain Magnetic Resonance Image (MRI) - T1 Image grey matter volume [ Time Frame: approximately 2 weeks ]
    change in grey matter volume
  • Brain MRI - functional MRI [ Time Frame: approximately 2 weeks ]
    change in Pearson's correlation coefficient of BOLD signals
  • Brain MRI - Diffusion Tensor Image (DTI) functional anisotropy [ Time Frame: approximately 2 weeks ]
    change in fractional anisotropy
  • Brain MRI - Diffusion Tensor Image (DTI) mean diffusivity [ Time Frame: approximately 2 weeks ]
    change in mean diffusivity
  • Brain MRI - Diffusion Tensor Image (DTI) radial diffusivity [ Time Frame: approximately 2 weeks ]
    change in radial diffusivity
  • Brain MRI - Diffusion Tensor Image (DTI) axial diffusivity [ Time Frame: approximately 2 weeks ]
    change in axial diffusivity
  • Brain MRI - myelin image [ Time Frame: approximately 2 weeks ]
    change in myelin imaging intensity value
  • Kicer values change with treatment in striatum assessed by 18F-DOPA Positron Emission Tomography (PET) [ Time Frame: approximately 2 weeks ]
    - Kicer values change with treatment in striatum
  • Magnetic Resonance Spectroscopy (MRS) [ Time Frame: approximately 2 weeks ]
    - 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 [ Time Frame: approximately 2 weeks ]
    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 [ Time Frame: approximately 2 weeks ]
    Auditory hallucination change by changes in the Korean Version of Hamilton Program for Schizophrenia Voices Questionnaire score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Refractory Auditory Verbal Hallucinations With tDCS in Schizophrenia
Official Title  ICMJE A Pilot Study for the Treatment of Refractory Auditory Verbal Hallucinations With Transcranial Direct Current Stimulation(tDCS) in Patients With Schizophrenia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE 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 Name: YDT-201N
Study Arms  ICMJE Experimental: tDCS
Patients with schizophrenia to receive tDCS treatment
Intervention: Device: tDCS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02451371
Other Study ID Numbers  ICMJE 1501-022-638
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jun Soo Kwon, MD, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP