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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

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Device: tDCS Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study for the Treatment of Refractory Auditory Verbal Hallucinations With Transcranial Direct Current Stimulation(tDCS) in Patients With Schizophrenia
Study Start Date : August 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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 Name: YDT-201N




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451371


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jun Soo Kwon, MD, PhD Seoul National University Hospital

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02451371     History of Changes
Other Study ID Numbers: 1501-022-638
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: August 2016
Keywords provided by Seoul National University Hospital:
Schizophrenia
Refractory auditory hallucination
tDCS
Additional relevant MeSH terms:
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Hallucinations
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms