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The Effect of tDCS on Schizophrenia With Negative Symptoms

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
tDCS
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, tDCS, negative symptoms

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

actual tDCS

sham tDCS

Arm Description

2mA direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions

sham direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Electroencephalography - resting
changes in lagged phase synchronization and microstate connectivity
Electroencephalography - P300
changes in P300
Electroencephalography - MMN
changes in MMN
Electroencephalography - ERN
changes in ERN
MRI - grey matter volume
change in grey matter volume
MRI - cortical thickness
change in cortical thickness
MRI - cortical surface area
changes in MRI - cortical thickness
MRI - cortical gyrification
changes in cortical gyrification
DTI - mean diffusivity (MD)
changes in MD
DTI - axial diffusivity (AD)
changes in AD
DTI - radial diffusivity (RD)
changes in RD
DTI - fractional anisotropy (FA)
changes in FA
MRI - rsfMRI
change in BOLD signals
MRI - MRS
Changes in concentration of N-Acetyl Aspartate, Creatin, Choline, Myoinositol, Glutamate, Glutamine, GABA metabolite concentration change with treatment
fNIRS
change in level of the Oxy-Hemoglobin
Korean Wechsler Adult Intelligence Scale (K-WAIS)
baseline total Intelligence quotient value
Spatial Working Memory
changes in the spatial working memory ability
California Verbal Learning Test
changes in verbal learning ability
Letter/Category fluency test
changes in fluency ability

Full Information

First Posted
October 30, 2018
Last Updated
October 2, 2019
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03729791
Brief Title
The Effect of tDCS on Schizophrenia With Negative Symptoms
Official Title
Clinical Trials for Neuroimaging and Electrophysiology in Schizophrenic Patients With Negative Symptoms Using Transcranial Direct Current Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, tDCS, negative symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial 1 arm is active tDCS and 1 arm is sham tDCS
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
actual tDCS
Arm Type
Experimental
Arm Description
2mA direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions
Arm Title
sham tDCS
Arm Type
Active Comparator
Arm Description
sham direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
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
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)
Description
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
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Secondary Outcome Measure Information:
Title
The Clinical Assessment Interview for Negative Symptoms (CAINS)
Description
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
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Title
Electroencephalography - resting
Description
changes in lagged phase synchronization and microstate connectivity
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Title
Electroencephalography - P300
Description
changes in P300
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Title
Electroencephalography - MMN
Description
changes in MMN
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Title
Electroencephalography - ERN
Description
changes in ERN
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Title
MRI - grey matter volume
Description
change in grey matter volume
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Title
MRI - cortical thickness
Description
change in cortical thickness
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Title
MRI - cortical surface area
Description
changes in MRI - cortical thickness
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Title
MRI - cortical gyrification
Description
changes in cortical gyrification
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Title
DTI - mean diffusivity (MD)
Description
changes in MD
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Title
DTI - axial diffusivity (AD)
Description
changes in AD
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Title
DTI - radial diffusivity (RD)
Description
changes in RD
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Title
DTI - fractional anisotropy (FA)
Description
changes in FA
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Title
MRI - rsfMRI
Description
change in BOLD signals
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Title
MRI - MRS
Description
Changes in concentration of N-Acetyl Aspartate, Creatin, Choline, Myoinositol, Glutamate, Glutamine, GABA metabolite concentration change with treatment
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Title
fNIRS
Description
change in level of the Oxy-Hemoglobin
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Title
Korean Wechsler Adult Intelligence Scale (K-WAIS)
Description
baseline total Intelligence quotient value
Time Frame
baseline
Title
Spatial Working Memory
Description
changes in the spatial working memory ability
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Title
California Verbal Learning Test
Description
changes in verbal learning ability
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)
Title
Letter/Category fluency test
Description
changes in fluency ability
Time Frame
approximately 2 weeks (baseline and 2 weeks followups)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae Young Lee, MD
Phone
82236687663
Email
leetaey@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae Young Lee, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Young Lee, MD
Phone
82236687663
Email
leetaey@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of tDCS on Schizophrenia With Negative Symptoms

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