Treatment of Refractory Auditory Verbal Hallucinations With tDCS in Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02451371
• Other study ID #: 1501-022-638
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 27, 2015
• Last updated: December 28, 2016
• Start date: August 2016
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 50 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hallucinations
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	approximately 2 weeks	No
Secondary	Electroencephalography - resting	change in lagged phase synchronization value; change in microstate connectivity value	approximately 2 weeks	No
Secondary	Electroencephalography - P300 peak	change in P300 peak amplitude during auditory oddball task; change in P300 peak latency during auditory oddball task	approximately 2 weeks	No
Secondary	Electroencephalography - P300 source	change in P300 source strength during auditory oddball task; change in P300 source location during auditory oddball task	approximately 2 weeks	No
Secondary	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	approximately 2 weeks	No
Secondary	Electroencephalography - ERN (error-related negativity) peak	change in ERN peak amplitude during flanker task; change in ERN peak latency during flanker task	approximately 2 weeks	No
Secondary	Electroencephalography - ERN (error-related negativity) source	change in ERN source strength during flanker task; change in ERN source location during flanker task	approximately 2 weeks	No
Secondary	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	approximately 2 weeks	No
Secondary	Brain Magnetic Resonance Image (MRI) - T1 Image grey matter thickness	change in grey matter thickness	approximately 2 weeks	No
Secondary	Brain Magnetic Resonance Image (MRI) - T1 Image grey matter volume	change in grey matter volume	approximately 2 weeks	No
Secondary	Brain MRI - functional MRI	change in Pearson's correlation coefficient of BOLD signals	approximately 2 weeks	No
Secondary	Brain MRI - Diffusion Tensor Image (DTI) functional anisotropy	change in fractional anisotropy	approximately 2 weeks	No
Secondary	Brain MRI - Diffusion Tensor Image (DTI) mean diffusivity	change in mean diffusivity	approximately 2 weeks	No
Secondary	Brain MRI - Diffusion Tensor Image (DTI) radial diffusivity	change in radial diffusivity	approximately 2 weeks	No
Secondary	Brain MRI - Diffusion Tensor Image (DTI) axial diffusivity	change in axial diffusivity	approximately 2 weeks	No
Secondary	Brain MRI - myelin image	change in myelin imaging intensity value	approximately 2 weeks	No
Secondary	Kicer values change with treatment in striatum assessed by 18F-DOPA Positron Emission Tomography (PET)	- Kicer values change with treatment in striatum	approximately 2 weeks	No
Secondary	Magnetic Resonance Spectroscopy (MRS)	- N-Acetyl Aspartate, Creatin, Choline, Myoinositol, Glutamate, Glutamine, GABA metabolite concentration change with treatment	approximately 2 weeks	No
Secondary	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	approximately 2 weeks	No
Secondary	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	approximately 2 weeks	No