Clinical trial NCT03729791: The Effect of tDCS on Schizophrenia With Negative Symptoms
Official title: Clinical Trials for Neuroimaging and Electrophysiology in Schizophrenic Patients With Negative Symptoms Using Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
tDCS
negative symptoms
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial

1 arm is active tDCS and 1 arm is sham tDCS
Primary purpose: TREATMENT

Brief summary: The investigators conducted a randomized controlled trial to reveal the effect of tDCS on negative symptoms in patients with schizophrenia and its underlying mechanism using the neuroimaging and electrophysiology.

Detailed description: The project will investigate the use of a novel technique, transcranial direct current stimulation (tDCS) in the treatment of patients with schizophrenia. tDCS permit the application of an extremely weak continuous electrical current to the brain through an anode and a cathode applied on the scalp. Anodal stimulation appears to increase brain activity whereas cathodal stimulation has the opposite effect.

Using anodal and cathodal tDCS the investigators aimed to treat negative symptoms of schizophrenia. The investigators plan to apply tDCS such that it can simultaneously increased activity in the frontal brain areas and reduce activity over temporoparietal cortex, 2 areas involved in the physiopathology of the disease. Real active stimulation will be compare to a sham condition in 44 patients (22 in each group). 44 patients will be included in Seoul National University Hospital

Eligibility criteria: Inclusion Criteria:

* DSM-IV Schizophrenia
* 1 or more items of Negative symptom score in PANSS \> 5

Exclusion Criteria:

* presences of neurological disorder or history
* IQ \< 70
* presence of severe personality disorders
* presence of substance use disorder (except nicotin)
* pregnancy
* presence of severe medical condition or disorders

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
Secondary outcomes:
measure: The Clinical Assessment Interview for Negative Symptoms (CAINS)
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
measure: Electroencephalography - resting
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
measure: Electroencephalography - P300
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
measure: Electroencephalography - MMN
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
measure: Electroencephalography - ERN
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
measure: MRI - grey matter volume
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
measure: MRI - cortical thickness
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
measure: MRI - cortical surface area
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
measure: MRI - cortical gyrification
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
measure: DTI - mean diffusivity (MD)
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
measure: DTI - axial diffusivity (AD)
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
measure: DTI - radial diffusivity (RD)
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
measure: DTI - fractional anisotropy (FA)
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
measure: MRI - rsfMRI
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
measure: MRI - MRS
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
measure: fNIRS
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
measure: Korean Wechsler Adult Intelligence Scale (K-WAIS)
timeFrame: baseline
measure: Spatial Working Memory
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
measure: California Verbal Learning Test
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
measure: Letter/Category fluency test
timeFrame: approximately 2 weeks (baseline and 2 weeks followups)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Tae Young Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: