SchizophreniaNCT03729791
The Effect of tDCS on Schizophrenia With Negative Symptoms
A study testing tDCS in people with Schizophrenia, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- DSM-IV Schizophrenia
- 1 or more items of Negative symptom score in PANSS > 5
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Schizophrenia
- Being tested
- tDCS
- Keywords
- Schizophrenia, tDCS, negative symptoms
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: approximately 2 weeks (baseline and 2 weeks followups)
Secondary outcomes (20)
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
Measured: approximately 2 weeks (baseline and 2 weeks followups)
Electroencephalography - resting
changes in lagged phase synchronization and microstate connectivity
Measured: approximately 2 weeks (baseline and 2 weeks followups)
Electroencephalography - P300
changes in P300
Measured: approximately 2 weeks (baseline and 2 weeks followups)
Electroencephalography - MMN
changes in MMN
Measured: approximately 2 weeks (baseline and 2 weeks followups)
Electroencephalography - ERN
changes in ERN
Measured: approximately 2 weeks (baseline and 2 weeks followups)
MRI - grey matter volume
change in grey matter volume
Measured: approximately 2 weeks (baseline and 2 weeks followups)
MRI - cortical thickness
change in cortical thickness
Measured: approximately 2 weeks (baseline and 2 weeks followups)
MRI - cortical surface area
changes in MRI - cortical thickness
Measured: approximately 2 weeks (baseline and 2 weeks followups)
MRI - cortical gyrification
changes in cortical gyrification
Measured: approximately 2 weeks (baseline and 2 weeks followups)
DTI - mean diffusivity (MD)
changes in MD
Measured: approximately 2 weeks (baseline and 2 weeks followups)
DTI - axial diffusivity (AD)
changes in AD
Measured: approximately 2 weeks (baseline and 2 weeks followups)
DTI - radial diffusivity (RD)
changes in RD
Measured: approximately 2 weeks (baseline and 2 weeks followups)
DTI - fractional anisotropy (FA)
changes in FA
Measured: approximately 2 weeks (baseline and 2 weeks followups)
MRI - rsfMRI
change in BOLD signals
Measured: 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
Measured: approximately 2 weeks (baseline and 2 weeks followups)
fNIRS
change in level of the Oxy-Hemoglobin
Measured: approximately 2 weeks (baseline and 2 weeks followups)
Korean Wechsler Adult Intelligence Scale (K-WAIS)
baseline total Intelligence quotient value
Measured: baseline
Spatial Working Memory
changes in the spatial working memory ability
Measured: approximately 2 weeks (baseline and 2 weeks followups)
California Verbal Learning Test
changes in verbal learning ability
Measured: approximately 2 weeks (baseline and 2 weeks followups)
Letter/Category fluency test
changes in fluency ability
Measured: approximately 2 weeks (baseline and 2 weeks followups)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start1 Dec 2019 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Why it stopped: Cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial 1 arm is active tDCS and 1 arm is sham tDCS
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Young Lee, MD, Seoul National University Hospital
- Investigators
- Tae Young Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729791
- Sponsor's protocol ID
- 1.001
- Status last verified
- Apr 2026
- First submitted
- 30 Oct 2018
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trials for Neuroimaging and Electrophysiology in Schizophrenic Patients With Negative Symptoms Using Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT03729791
- Acronym / sponsor ID
- 1.001
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, tDCS, negative symptoms
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial 1 arm is active tDCS and 1 arm is sham tDCS
| Arm | Type | Receives |
|---|---|---|
| actual tDCS | Experimental | Device: tDCS2mA 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 | Device: tDCSsham direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- DSM-IV Schizophrenia
- 1 or more items of Negative symptom score in PANSS > 5
Key exclusion criteria (6 listed)
- presences of neurological disorder or history
- IQ < 70
- presence of severe personality disorders
- presence of substance use disorder (except nicotin)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSTranscranial 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 | Device | actual tDCS, sham tDCS |
Primary outcome
Positive and Negative Syndrome Scale (PANSS)
Time frame: 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
20 secondary outcomes
The Clinical Assessment Interview for Negative Symptoms (CAINS)
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
Electroencephalography - resting
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
Electroencephalography - P300
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
Electroencephalography - MMN
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
Electroencephalography - ERN
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
MRI - grey matter volume
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
MRI - cortical thickness
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
MRI - cortical surface area
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
MRI - cortical gyrification
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
DTI - mean diffusivity (MD)
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
DTI - axial diffusivity (AD)
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
DTI - radial diffusivity (RD)
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
DTI - fractional anisotropy (FA)
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
MRI - rsfMRI
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
MRI - MRS
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
fNIRS
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
Korean Wechsler Adult Intelligence Scale (K-WAIS)
Time frame: baseline
Spatial Working Memory
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
California Verbal Learning Test
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
Letter/Category fluency test
Time frame: approximately 2 weeks (baseline and 2 weeks followups)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tae Young Lee, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Schizophrenia, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (PANSS) (time frame: approximately 2 weeks (baseline and 2 weeks followups)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.