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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

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Device: tDCS Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
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
Official Title: Clinical Trials for Neuroimaging and Electrophysiology in Schizophrenic Patients With Negative Symptoms Using Transcranial Direct Current Stimulation
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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
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

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
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Electroencephalography - resting [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in lagged phase synchronization and microstate connectivity

  3. Electroencephalography - P300 [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in P300

  4. Electroencephalography - MMN [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in MMN

  5. Electroencephalography - ERN [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in ERN

  6. MRI - grey matter volume [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    change in grey matter volume

  7. MRI - cortical thickness [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    change in cortical thickness

  8. MRI - cortical surface area [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in MRI - cortical thickness

  9. MRI - cortical gyrification [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in cortical gyrification

  10. DTI - mean diffusivity (MD) [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in MD

  11. DTI - axial diffusivity (AD) [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in AD

  12. DTI - radial diffusivity (RD) [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in RD

  13. DTI - fractional anisotropy (FA) [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in FA

  14. MRI - rsfMRI [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    change in BOLD signals

  15. 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

  16. fNIRS [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    change in level of the Oxy-Hemoglobin

  17. Korean Wechsler Adult Intelligence Scale (K-WAIS) [ Time Frame: baseline ]
    baseline total Intelligence quotient value

  18. Spatial Working Memory [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in the spatial working memory ability

  19. California Verbal Learning Test [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in verbal learning ability

  20. Letter/Category fluency test [ Time Frame: approximately 2 weeks (baseline and 2 weeks followups) ]
    changes in fluency ability



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729791


Contacts
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Contact: Tae Young Lee, MD 82236687663 leetaey@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Contact: Tae Young Lee, MD    82236687663    leetaey@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Tae Young Lee, MD Seoul National University Hospital
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Responsible Party: Tae Young Lee, MD, Research Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03729791    
Other Study ID Numbers: 1.001
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tae Young Lee, MD, Seoul National University Hospital:
Schizophrenia
tDCS
negative symptoms
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders