The Effect of tDCS on Schizophrenia With Negative Symptoms

NCT03729791 | Withdrawn

• 1 other identifier: 1.001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; tDCS; negative symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• The Clinical Assessment Interview for Negative Symptoms (CAINS)

  approximately 2 weeks (baseline and 2 weeks followups)

• Electroencephalography - resting

  approximately 2 weeks (baseline and 2 weeks followups)

• Electroencephalography - P300

  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)

Study Arms (2)

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

Device: tDCS

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

Device: tDCS

Interventions

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

actual tDCS; sham tDCS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• DSM-IV Schizophrenia
• or more items of Negative symptom score in PANSS \> 5

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Tae Young Lee, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Model Details: Randomized controlled trial 1 arm is active tDCS and 1 arm is sham tDCS

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 5, 2018
• Study Start: December 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)