The Effect of tDCS on Schizophrenia With Negative Symptoms

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Schizophrenia
• Intervention / Treatment: Device: tDCS

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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Tae Young Lee, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2019
• Primary Completion (Estimated): December 1, 2020
• Study Completion (Estimated): December 1, 2020

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Schizophrenia; tDCS; negative symptoms
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; Therapeutics; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Transcranial Direct Current Stimulation
• Other Study ID Numbers: 1.001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No