Skip to main content
OpenTrials
Completed

NCT Number: NCT02451371

Treatment of Refractory Auditory Verbal Hallucinations With tDCS in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Hallucinations Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Electroencephalography - resting

    Time frame: approximately 2 weeks

    • change in lagged phase synchronization value
    • change in microstate connectivity value

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Brain Magnetic Resonance Image (MRI) - T1 Image grey matter thickness

    Time frame: approximately 2 weeks

    change in grey matter thickness

  9. Brain Magnetic Resonance Image (MRI) - T1 Image grey matter volume

    Time frame: approximately 2 weeks

    change in grey matter volume

  10. Brain MRI - functional MRI

    Time frame: approximately 2 weeks

    change in Pearson's correlation coefficient of BOLD signals

  11. Brain MRI - Diffusion Tensor Image (DTI) functional anisotropy

    Time frame: approximately 2 weeks

    change in fractional anisotropy

  12. Brain MRI - Diffusion Tensor Image (DTI) mean diffusivity

    Time frame: approximately 2 weeks

    change in mean diffusivity

  13. Brain MRI - Diffusion Tensor Image (DTI) radial diffusivity

    Time frame: approximately 2 weeks

    change in radial diffusivity

  14. Brain MRI - Diffusion Tensor Image (DTI) axial diffusivity

    Time frame: approximately 2 weeks

    change in axial diffusivity

  15. Brain MRI - myelin image

    Time frame: approximately 2 weeks

    change in myelin imaging intensity value

  16. 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

  17. Magnetic Resonance Spectroscopy (MRS)

    Time frame: approximately 2 weeks

    • N-Acetyl Aspartate, Creatin, Choline, Myoinositol, Glutamate, Glutamine, GABA metabolite concentration change with treatment

  18. 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

  19. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 22, 2015
Registry last updated
Dec 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.