The Effect of tDCS on Schizophrenia With Negative Symptoms

Schizophrenia Clinical Trial

Official title:

Clinical Trials for Neuroimaging and Electrophysiology in Schizophrenic Patients With Negative Symptoms Using Transcranial Direct Current Stimulation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03729791
• Other study ID #: 1.001
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: October 2019
• Source: Seoul National University Hospital
• Contact: Tae Young Lee, MD
• Phone: 82236687663
• Email: leetaey[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Device:
• tDCS
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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	Electroencephalography - resting	changes in lagged phase synchronization and microstate connectivity	approximately 2 weeks (baseline and 2 weeks followups)
Secondary	Electroencephalography - P300	changes in P300	approximately 2 weeks (baseline and 2 weeks followups)
Secondary	Electroencephalography - MMN	changes in MMN	approximately 2 weeks (baseline and 2 weeks followups)
Secondary	Electroencephalography - ERN	changes in ERN	approximately 2 weeks (baseline and 2 weeks followups)
Secondary	MRI - grey matter volume	change in grey matter volume	approximately 2 weeks (baseline and 2 weeks followups)
Secondary	MRI - cortical thickness	change in cortical thickness	approximately 2 weeks (baseline and 2 weeks followups)
Secondary	MRI - cortical surface area	changes in MRI - cortical thickness	approximately 2 weeks (baseline and 2 weeks followups)
Secondary	MRI - cortical gyrification	changes in cortical gyrification	approximately 2 weeks (baseline and 2 weeks followups)
Secondary	DTI - mean diffusivity (MD)	changes in MD	approximately 2 weeks (baseline and 2 weeks followups)
Secondary	DTI - axial diffusivity (AD)	changes in AD	approximately 2 weeks (baseline and 2 weeks followups)
Secondary	DTI - radial diffusivity (RD)	changes in RD	approximately 2 weeks (baseline and 2 weeks followups)
Secondary	DTI - fractional anisotropy (FA)	changes in FA	approximately 2 weeks (baseline and 2 weeks followups)
Secondary	MRI - rsfMRI	change in BOLD signals	approximately 2 weeks (baseline and 2 weeks followups)
Secondary	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)
Secondary	fNIRS	change in level of the Oxy-Hemoglobin	approximately 2 weeks (baseline and 2 weeks followups)
Secondary	Korean Wechsler Adult Intelligence Scale (K-WAIS)	baseline total Intelligence quotient value	baseline
Secondary	Spatial Working Memory	changes in the spatial working memory ability	approximately 2 weeks (baseline and 2 weeks followups)
Secondary	California Verbal Learning Test	changes in verbal learning ability	approximately 2 weeks (baseline and 2 weeks followups)
Secondary	Letter/Category fluency test	changes in fluency ability	approximately 2 weeks (baseline and 2 weeks followups)