Treatment of Refractory Auditory Verbal Hallucinations With tDCS in Schizophrenia

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Device: tDCS

• Registration Number: NCT02451371
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-27
• Study First Submitted QC: 2015-05-18
• Study First Posted: 2015-05-22
• Status Verified: 2016-08
• Study Start: 2016-08
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-28
• Last Update Posted: 2016-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tDCS	tDCS	Patients with schizophrenia to receive tDCS treatment

Primary Outcome Measures

Name	Time	Method
Auditory hallucination change by changes in The Psychotic Symptom Rating Scales (PSYRATs) Auditory hallucinations subscale score	approximately 2 weeks	Auditory hallucination change by changes in the auditory hallucinations subscale from the Psychotic Symptom Rating Scales

Secondary Outcome Measures

Name	Time	Method
Brain Magnetic Resonance Image (MRI) - T1 Image grey matter volume	approximately 2 weeks	change in grey matter volume
Electroencephalography - resting	approximately 2 weeks	* change in lagged phase synchronization value; * change in microstate connectivity value
Electroencephalography - P300 peak	approximately 2 weeks	* change in P300 peak amplitude during auditory oddball task; * change in P300 peak latency during auditory oddball task
Electroencephalography - P300 source	approximately 2 weeks	* change in P300 source strength during auditory oddball task; * change in P300 source location during auditory oddball task
Electroencephalography - P50	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
Brain MRI - functional MRI	approximately 2 weeks	change in Pearson's correlation coefficient of BOLD signals
Brain MRI - Diffusion Tensor Image (DTI) functional anisotropy	approximately 2 weeks	change in fractional anisotropy
Electroencephalography - ERN (error-related negativity) peak	approximately 2 weeks	* change in ERN peak amplitude during flanker task; * change in ERN peak latency during flanker task
Electroencephalography - ERN (error-related negativity) frequency activity	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	approximately 2 weeks	change in grey matter thickness
Electroencephalography - ERN (error-related negativity) source	approximately 2 weeks	* change in ERN source strength during flanker task; * change in ERN source location during flanker task
Brain MRI - Diffusion Tensor Image (DTI) mean diffusivity	approximately 2 weeks	change in mean diffusivity
Brain MRI - Diffusion Tensor Image (DTI) axial diffusivity	approximately 2 weeks	change in axial diffusivity
Brain MRI - Diffusion Tensor Image (DTI) radial diffusivity	approximately 2 weeks	change in radial diffusivity
Brain MRI - myelin image	approximately 2 weeks	change in myelin imaging intensity value
Kicer values change with treatment in striatum assessed by 18F-DOPA Positron Emission Tomography (PET)	approximately 2 weeks	- Kicer values change with treatment in striatum
Auditory hallucination change by changes in the Korean Version of Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ) score	approximately 2 weeks	Auditory hallucination change by changes in the Korean Version of Hamilton Program for Schizophrenia Voices Questionnaire score
Magnetic Resonance Spectroscopy (MRS)	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	approximately 2 weeks	Auditory hallucination change by changes in the Auditory Hallucination Rating Scale score

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of