The Effect of tDCS on Schizophrenia With Negative Symptoms

NCT ID: NCT03729791

Last Updated: 2019-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-12-01

Brief Summary

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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

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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

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

1 arm is active tDCS and 1 arm is sham tDCS
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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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

Group Type EXPERIMENTAL

tDCS

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

tDCS

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tae Young Lee, MD

Research Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae Young Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Tae Young Lee, MD

Role: CONTACT

82236687663

Facility Contacts

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Tae Young Lee, MD

Role: primary

82236687663

Other Identifiers

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1.001

Identifier Type: -

Identifier Source: org_study_id

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