Clinical Trials for Neuroimaging and Electrophysiology in Schizophrenic Patients With Negative Symptoms Using Transcranial Direct Current Stimulation
Overview
- Phase
- N/A
- Intervention
- tDCS
- Conditions
- Schizophrenia
- Sponsor
- Seoul National University Hospital
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Positive and Negative Syndrome Scale (PANSS)
- Status
- Withdrawn
- Last Updated
- 8 days ago
Overview
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
Investigators
Tae Young Lee, MD
Research Professor
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
- •presence of severe personality disorders
- •presence of substance use disorder (except nicotin)
- •pregnancy
- •presence of severe medical condition or disorders
Arms & Interventions
actual 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
Intervention: tDCS
sham 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
Intervention: tDCS
Outcomes
Primary Outcomes
Positive and Negative Syndrome Scale (PANSS)
Time Frame: 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 Outcomes
- The Clinical Assessment Interview for Negative Symptoms (CAINS)(approximately 2 weeks (baseline and 2 weeks followups))
- DTI - radial diffusivity (RD)(approximately 2 weeks (baseline and 2 weeks followups))
- DTI - fractional anisotropy (FA)(approximately 2 weeks (baseline and 2 weeks followups))
- MRI - MRS(approximately 2 weeks (baseline and 2 weeks followups))
- Letter/Category fluency test(approximately 2 weeks (baseline and 2 weeks followups))
- MRI - cortical thickness(approximately 2 weeks (baseline and 2 weeks followups))
- MRI - cortical gyrification(approximately 2 weeks (baseline and 2 weeks followups))
- Electroencephalography - MMN(approximately 2 weeks (baseline and 2 weeks followups))
- Electroencephalography - ERN(approximately 2 weeks (baseline and 2 weeks followups))
- MRI - cortical surface area(approximately 2 weeks (baseline and 2 weeks followups))
- DTI - axial diffusivity (AD)(approximately 2 weeks (baseline and 2 weeks followups))
- Electroencephalography - P300(approximately 2 weeks (baseline and 2 weeks followups))
- MRI - grey matter volume(approximately 2 weeks (baseline and 2 weeks followups))
- Korean Wechsler Adult Intelligence Scale (K-WAIS)(baseline)
- Spatial Working Memory(approximately 2 weeks (baseline and 2 weeks followups))
- California Verbal Learning Test(approximately 2 weeks (baseline and 2 weeks followups))
- Electroencephalography - resting(approximately 2 weeks (baseline and 2 weeks followups))
- DTI - mean diffusivity (MD)(approximately 2 weeks (baseline and 2 weeks followups))
- MRI - rsfMRI(approximately 2 weeks (baseline and 2 weeks followups))
- fNIRS(approximately 2 weeks (baseline and 2 weeks followups))