Not provided
Not provided
Not provided
Not provided
Not provided
Cancelled
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| actual tDCS | Experimental | 2mA direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions |
|
| sham tDCS | Active Comparator | sham direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | Transcranial direct current stimulation (tDCS) is a form of neurostimulation that uses constant, low direct current delivered via electrodes on the head. It can be contrasted with cranial electrotherapy stimulation, which generally uses alternating current the same way |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) | 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 | approximately 2 weeks (baseline and 2 weeks followups) |
| Measure | Description | Time Frame |
|---|---|---|
| The Clinical Assessment Interview for Negative Symptoms (CAINS) | 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 | approximately 2 weeks (baseline and 2 weeks followups) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tae Young Lee, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
Randomized controlled trial
1 arm is active tDCS and 1 arm is sham tDCS
Not provided
Not provided
All researchers will conduct research with only the encrypted subject number. A separate third-party researcher will participate to encrypt the subject and adjust the active/sham direction of the tDCS device during the actual research.
|
| Electroencephalography - resting | changes in lagged phase synchronization and microstate connectivity | approximately 2 weeks (baseline and 2 weeks followups) |
| Electroencephalography - P300 | changes in P300 | approximately 2 weeks (baseline and 2 weeks followups) |
| Electroencephalography - MMN | changes in MMN | approximately 2 weeks (baseline and 2 weeks followups) |
| Electroencephalography - ERN | changes in ERN | approximately 2 weeks (baseline and 2 weeks followups) |
| MRI - grey matter volume | change in grey matter volume | approximately 2 weeks (baseline and 2 weeks followups) |
| MRI - cortical thickness | change in cortical thickness | approximately 2 weeks (baseline and 2 weeks followups) |
| MRI - cortical surface area | changes in MRI - cortical thickness | approximately 2 weeks (baseline and 2 weeks followups) |
| MRI - cortical gyrification | changes in cortical gyrification | approximately 2 weeks (baseline and 2 weeks followups) |
| DTI - mean diffusivity (MD) | changes in MD | approximately 2 weeks (baseline and 2 weeks followups) |
| DTI - axial diffusivity (AD) | changes in AD | approximately 2 weeks (baseline and 2 weeks followups) |
| DTI - radial diffusivity (RD) | changes in RD | approximately 2 weeks (baseline and 2 weeks followups) |
| DTI - fractional anisotropy (FA) | changes in FA | approximately 2 weeks (baseline and 2 weeks followups) |
| MRI - rsfMRI | change in BOLD signals | approximately 2 weeks (baseline and 2 weeks followups) |
| MRI - MRS | Changes in concentration of N-Acetyl Aspartate, Creatin, Choline, Myoinositol, Glutamate, Glutamine, GABA metabolite concentration change with treatment | approximately 2 weeks (baseline and 2 weeks followups) |
| fNIRS | change in level of the Oxy-Hemoglobin | approximately 2 weeks (baseline and 2 weeks followups) |
| Korean Wechsler Adult Intelligence Scale (K-WAIS) | baseline total Intelligence quotient value | baseline |
| Spatial Working Memory | changes in the spatial working memory ability | approximately 2 weeks (baseline and 2 weeks followups) |
| California Verbal Learning Test | changes in verbal learning ability | approximately 2 weeks (baseline and 2 weeks followups) |
| Letter/Category fluency test | changes in fluency ability | approximately 2 weeks (baseline and 2 weeks followups) |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |