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The Effect of tDCS on Schizophrenia With Negative Symptoms

2. oktober 2019 oppdatert av: Tae Young Lee, MD, Seoul National University Hospital

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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Forventet)

44

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 50 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Enhet: 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
Aktiv komparator: 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
Enhet: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Positive and Negative Syndrome Scale (PANSS)
Tidsramme: 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
approximately 2 weeks (baseline and 2 weeks followups)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Clinical Assessment Interview for Negative Symptoms (CAINS)
Tidsramme: 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
approximately 2 weeks (baseline and 2 weeks followups)
Electroencephalography - resting
Tidsramme: approximately 2 weeks (baseline and 2 weeks followups)
changes in lagged phase synchronization and microstate connectivity
approximately 2 weeks (baseline and 2 weeks followups)
Electroencephalography - P300
Tidsramme: approximately 2 weeks (baseline and 2 weeks followups)
changes in P300
approximately 2 weeks (baseline and 2 weeks followups)
Electroencephalography - MMN
Tidsramme: approximately 2 weeks (baseline and 2 weeks followups)
changes in MMN
approximately 2 weeks (baseline and 2 weeks followups)
Electroencephalography - ERN
Tidsramme: approximately 2 weeks (baseline and 2 weeks followups)
changes in ERN
approximately 2 weeks (baseline and 2 weeks followups)
MRI - grey matter volume
Tidsramme: approximately 2 weeks (baseline and 2 weeks followups)
change in grey matter volume
approximately 2 weeks (baseline and 2 weeks followups)
MRI - cortical thickness
Tidsramme: approximately 2 weeks (baseline and 2 weeks followups)
change in cortical thickness
approximately 2 weeks (baseline and 2 weeks followups)
MRI - cortical surface area
Tidsramme: approximately 2 weeks (baseline and 2 weeks followups)
changes in MRI - cortical thickness
approximately 2 weeks (baseline and 2 weeks followups)
MRI - cortical gyrification
Tidsramme: approximately 2 weeks (baseline and 2 weeks followups)
changes in cortical gyrification
approximately 2 weeks (baseline and 2 weeks followups)
DTI - mean diffusivity (MD)
Tidsramme: approximately 2 weeks (baseline and 2 weeks followups)
changes in MD
approximately 2 weeks (baseline and 2 weeks followups)
DTI - axial diffusivity (AD)
Tidsramme: approximately 2 weeks (baseline and 2 weeks followups)
changes in AD
approximately 2 weeks (baseline and 2 weeks followups)
DTI - radial diffusivity (RD)
Tidsramme: approximately 2 weeks (baseline and 2 weeks followups)
changes in RD
approximately 2 weeks (baseline and 2 weeks followups)
DTI - fractional anisotropy (FA)
Tidsramme: approximately 2 weeks (baseline and 2 weeks followups)
changes in FA
approximately 2 weeks (baseline and 2 weeks followups)
MRI - rsfMRI
Tidsramme: approximately 2 weeks (baseline and 2 weeks followups)
change in BOLD signals
approximately 2 weeks (baseline and 2 weeks followups)
MRI - MRS
Tidsramme: 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
approximately 2 weeks (baseline and 2 weeks followups)
fNIRS
Tidsramme: approximately 2 weeks (baseline and 2 weeks followups)
change in level of the Oxy-Hemoglobin
approximately 2 weeks (baseline and 2 weeks followups)
Korean Wechsler Adult Intelligence Scale (K-WAIS)
Tidsramme: baseline
baseline total Intelligence quotient value
baseline
Spatial Working Memory
Tidsramme: approximately 2 weeks (baseline and 2 weeks followups)
changes in the spatial working memory ability
approximately 2 weeks (baseline and 2 weeks followups)
California Verbal Learning Test
Tidsramme: approximately 2 weeks (baseline and 2 weeks followups)
changes in verbal learning ability
approximately 2 weeks (baseline and 2 weeks followups)
Letter/Category fluency test
Tidsramme: approximately 2 weeks (baseline and 2 weeks followups)
changes in fluency ability
approximately 2 weeks (baseline and 2 weeks followups)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Seoul National University Hospital

Etterforskere

  • Hovedetterforsker: Tae Young Lee, MD, Seoul National University Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. desember 2019

Primær fullføring (Forventet)

1. desember 2020

Studiet fullført (Forventet)

1. desember 2020

Datoer for studieregistrering

Først innsendt

30. oktober 2018

Først innsendt som oppfylte QC-kriteriene

31. oktober 2018

Først lagt ut (Faktiske)

5. november 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. oktober 2019

Sist bekreftet

1. oktober 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1.001

Plan for individuelle deltakerdata (IPD)

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Nei

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produkt produsert i og eksportert fra USA

Nei

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