Schizophrenia
Conditions
Keywords
Schizophrenia, tDCS, negative symptoms
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
Interventions
DEVICEtDCS
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
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Randomized controlled trial 1 arm is active tDCS and 1 arm is sham tDCS
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Electroencephalography - resting | approximately 2 weeks (baseline and 2 weeks followups) | changes in lagged phase synchronization and microstate connectivity |
| Electroencephalography - P300 | approximately 2 weeks (baseline and 2 weeks followups) | changes in P300 |
| 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 - grey matter volume | approximately 2 weeks (baseline and 2 weeks followups) | change in grey matter volume |
| MRI - cortical thickness | approximately 2 weeks (baseline and 2 weeks followups) | change in cortical thickness |
| MRI - cortical surface area | approximately 2 weeks (baseline and 2 weeks followups) | changes in MRI - cortical thickness |
| MRI - cortical gyrification | approximately 2 weeks (baseline and 2 weeks followups) | changes in cortical gyrification |
| DTI - mean diffusivity (MD) | approximately 2 weeks (baseline and 2 weeks followups) | changes in MD |
| DTI - axial diffusivity (AD) | approximately 2 weeks (baseline and 2 weeks followups) | changes in AD |
| 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 - rsfMRI | approximately 2 weeks (baseline and 2 weeks followups) | change in BOLD signals |
| 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 |
| fNIRS | approximately 2 weeks (baseline and 2 weeks followups) | change in level of the Oxy-Hemoglobin |
| 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 |
| Letter/Category fluency test | approximately 2 weeks (baseline and 2 weeks followups) | changes in fluency ability |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORTae Young Lee, MD
Seoul National University Hospital
Outcome results
None listed