The Effect of tDCS on Schizophrenia With Negative Symptoms
- Conditions
- Schizophrenia
- Interventions
- Device: tDCS
- Registration Number
- NCT03729791
- Lead Sponsor
- Seoul National University Hospital
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 44
- DSM-IV Schizophrenia
- 1 or more items of Negative symptom score in PANSS > 5
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sham tDCS tDCS sham direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions actual tDCS 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
- Primary Outcome Measures
Name Time Method Positive and Negative Syndrome Scale (PANSS) approximately 2 weeks (baseline and 2 weeks followups) changes in psychopathology To assess a patient using PANSS, an approximately 45-minute clinical interview is conducted. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers
- Secondary Outcome Measures
Name Time Method Letter/Category fluency test approximately 2 weeks (baseline and 2 weeks followups) changes in fluency ability
The Clinical Assessment Interview for Negative Symptoms (CAINS) approximately 2 weeks (baseline and 2 weeks followups) changes in psychopathology The CAINS is a clinical rating scale for negative symptoms with potent and clear treatment targets for the next generation of pharmacological and psychosocial treatments. It rangs between 0 to 52
DTI - radial diffusivity (RD) approximately 2 weeks (baseline and 2 weeks followups) changes in RD
DTI - fractional anisotropy (FA) approximately 2 weeks (baseline and 2 weeks followups) changes in FA
MRI - MRS approximately 2 weeks (baseline and 2 weeks followups) Changes in concentration of N-Acetyl Aspartate, Creatin, Choline, Myoinositol, Glutamate, Glutamine, GABA metabolite concentration change with treatment
MRI - cortical thickness approximately 2 weeks (baseline and 2 weeks followups) change in cortical thickness
MRI - cortical gyrification approximately 2 weeks (baseline and 2 weeks followups) changes in cortical gyrification
Electroencephalography - MMN approximately 2 weeks (baseline and 2 weeks followups) changes in MMN
Electroencephalography - ERN approximately 2 weeks (baseline and 2 weeks followups) changes in ERN
MRI - cortical surface area approximately 2 weeks (baseline and 2 weeks followups) changes in MRI - cortical thickness
DTI - axial diffusivity (AD) approximately 2 weeks (baseline and 2 weeks followups) changes in AD
Electroencephalography - P300 approximately 2 weeks (baseline and 2 weeks followups) changes in P300
MRI - grey matter volume approximately 2 weeks (baseline and 2 weeks followups) change in grey matter volume
Korean Wechsler Adult Intelligence Scale (K-WAIS) baseline baseline total Intelligence quotient value
Spatial Working Memory approximately 2 weeks (baseline and 2 weeks followups) changes in the spatial working memory ability
California Verbal Learning Test approximately 2 weeks (baseline and 2 weeks followups) changes in verbal learning ability
Electroencephalography - resting approximately 2 weeks (baseline and 2 weeks followups) changes in lagged phase synchronization and microstate connectivity
DTI - mean diffusivity (MD) approximately 2 weeks (baseline and 2 weeks followups) changes in MD
MRI - rsfMRI approximately 2 weeks (baseline and 2 weeks followups) change in BOLD signals
fNIRS approximately 2 weeks (baseline and 2 weeks followups) change in level of the Oxy-Hemoglobin
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of