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The Effect of tDCS on Schizophrenia With Negative Symptoms

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ClinicalTrials.gov Identifier: NCT03729791
Recruitment Status : Unknown
Verified October 2019 by Tae Young Lee, MD, Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 5, 2018
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Tae Young Lee, MD, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE October 30, 2018
First Posted Date  ICMJE November 5, 2018
Last Update Posted Date October 3, 2019
Estimated Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2018)
  • The Clinical Assessment Interview for Negative Symptoms (CAINS) [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    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 [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in lagged phase synchronization and microstate connectivity
  • Electroencephalography - P300 [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in P300
  • Electroencephalography - MMN [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in MMN
  • Electroencephalography - ERN [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in ERN
  • MRI - grey matter volume [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    change in grey matter volume
  • MRI - cortical thickness [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    change in cortical thickness
  • MRI - cortical surface area [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in MRI - cortical thickness
  • MRI - cortical gyrification [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in cortical gyrification
  • DTI - mean diffusivity (MD) [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in MD
  • DTI - axial diffusivity (AD) [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in AD
  • DTI - radial diffusivity (RD) [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in RD
  • DTI - fractional anisotropy (FA) [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in FA
  • MRI - rsfMRI [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    change in BOLD signals
  • MRI - MRS [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    Changes in concentration of N-Acetyl Aspartate, Creatin, Choline, Myoinositol, Glutamate, Glutamine, GABA metabolite concentration change with treatment
  • fNIRS [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    change in level of the Oxy-Hemoglobin
  • Korean Wechsler Adult Intelligence Scale (K-WAIS) [ Time Frame: baseline ]
    baseline total Intelligence quotient value
  • Spatial Working Memory [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in the spatial working memory ability
  • California Verbal Learning Test [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in verbal learning ability
  • Letter/Category fluency test [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in fluency ability
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • The Clinical Assessment Interview for Negative Symptoms (CAINS) [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    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 [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in lagged phase synchronization and microstate connectivity
  • Electroencephalography - P300 [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in P300
  • Electroencephalography - MMN [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in MMN
  • Electroencephalography - ERN [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in ERN
  • MRI - grey matter volume [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    change in grey matter volume
  • MRI - cortical thickness [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    change in cortical thickness
  • MRI - cortical surface area [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in MRI - cortical thickness
  • MRI - cortical gyrification [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in cortical gyrification
  • DTI - mean diffusivity (MD) [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in MD
  • DTI - axial diffusivity (AD) [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in AD
  • DTI - radial diffusivity (RD) [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in RD
  • DTI - fractional anisotropy (FA) [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in FA
  • MRI - rsfMRI [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    change in BOLD signals
  • MRI - MRS [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    Changes in concentration of N-Acetyl Aspartate, Creatin, Choline, Myoinositol, Glutamate, Glutamine, GABA metabolite concentration change with treatment
  • fNIRS [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    change in BOLD signals
  • Korean Wechsler Adult Intelligence Scale (K-WAIS) [ Time Frame: baseline ]
    baseline total IQ
  • Spatial Working Memory [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in spatial working memory
  • California Verbal Learning Test [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in verbal learning ability
  • Letter/Category fluency test [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in fluency ability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of tDCS on Schizophrenia With Negative Symptoms
Official Title  ICMJE Clinical Trials for Neuroimaging and Electrophysiology in Schizophrenic Patients With Negative Symptoms Using Transcranial Direct Current Stimulation
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized controlled trial

1 arm is active tDCS and 1 arm is sham tDCS

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Device: tDCS
  • 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
    Intervention: Device: tDCS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03729791
Other Study ID Numbers  ICMJE 1.001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tae Young Lee, MD, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tae Young Lee, MD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP