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Efficacy and Mechanisms of Transcranial Direct Current Stimulation (tDCS) - Effects on Working Memory in Schizophrenia

27. april 2021 opdateret af: Christian Plewnia, MD, University Hospital Tuebingen

Impairments of cognition are a core, severely disabling feature of schizophrenia leading to poor long-term outcome with no established treatment available.

Particularly impaired executive functions (e.g working memory) are frequently observed and are consistently associated with reduced activation of the dorsolateral prefrontal cortex (dlPFC). Deficits in those functions have been shown to be closely related to negative symptoms, thought disorder, and functional outcome in schizophrenia leading to the notion that frontal lobe dysfunction is crucially important in schizophrenic psychopathology.

Noninvasive brain stimulation like tDCS can enhance executive functions like working memory in healthy subjects as well as in patients. To identify the optimal parameters for this intervention in patients with schizophrenia, the investigators first test the effects of different polarities (anodal, cathodal), stimulation intensities (1mA, 2mA) and laterality (left, right) on working-memory performance (nback task) in a sham-controlled cross-over design (n=128). To elucidate mechanisms of action, oscillatory brain activity will be registered with electroencephalography (EEG).

These experiments will provide reliable data for an evidence-based development of new clinical interventions to improve treatment of cognitive deficits in patients with schizophrenia and thus enhance schizophrenia prevention and recovery.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  1. Working hypothesis:

    In patients with subacute schizophrenia, transcranial direct current stimulation (tDCS) to the dorsolateral prefrontal cortex (dlPFC) exerts lasting beneficial effects on working-memory performance.

  2. Research question(s):

    In patients with remitted early phase schizophrenia, this research project aims at providing evidence for:

    i) immediate improvement of working-memory performance by application of tDCS to the dlPFC in patients with schizophrenia; ii) determination of the optimal stimulation polarity, dosage and localization; iii) neurophysiological mechanisms (modulation in oscillatory activity and functional connectivity) and predictors of tDCS effects; iv) modulating effect of gender on the malleability of executive functions with tDCS.

  3. Previous work of the investigators:

    The investigators have provided proof-of principle evidence for persisting improvement of cognitive planning by a polarity-specific learning-stage dependent coupling of training and stimulation. The investigators have demonstrated that working memory and deficient cognitive control can be enhanced with anodal tDCS in depression and that the effects of tDCS are modulated by genetic polymorphisms. The investigators were the first to show impaired cortical plasticity following tDCS in schizophrenia patients at different disease states. Finally, the investigators have just successfully finished the world-wide largest clinical trial investigating the efficacy of non-invasive brain stimulation (rTMS) on negative symptoms in schizophrenia (DFG 241/10-1, Falkai, Hasan).

  4. Aims and work plan:

To examine the potential of tDCS for the improvement of working memory with remitted schizophrenia the investigators are following this work plan:

I) Immediate effects on performance:

Assessment of efficacy of tDCS polarity (anodal, cathodal), dosage (1mA, 2mA) and laterality (left and right dlPFC) on working memory (adaptive n-back(6)) in patients (n=2x2x2x16=128). In a two-session cross-over design, stimulation (tDCS and sham) will be applied to the dlPFC (left or right) for 20min (during task performance).

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

128

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyskland
      • Muenchen, Tyskland
        • Rekruttering
        • LMU Muenchen, Department of Psychiatry and Psychotherapy
        • Kontakt:
          • Alkomiet Hasan, MD
      • Tuebingen, Tyskland, 72076
        • Rekruttering
        • University Hospital Tuebigen, Department of Psychiatry and Psychotherapy
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • diagnosed schizophrenia (DSM-V)
  • age (18 - 60 years)
  • right handedness
  • stable medication during 1 week of treatment and 1 week before

Exclusion Criteria:

  • history of seizures
  • metal device throughout the body
  • pregnancy
  • use of anticonvulsive medication
  • use of benzodiazepines more than 1 mg of Lorazepam equivalent
  • current substance abuse (nicotine excluded)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Transcranial direct current stimulation
tDCS with varying intensity, location and polarity
Procedure: Transcranial direct current stimulation
Andre navne:
  • tDCS
Placebo komparator: Sham stimulation
Double blind sham stimulation with sham mode of neuroConn device
Procedure: Transcranial direct current stimulation
Andre navne:
  • tDCS

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change of dprime
Tidsramme: Assessment during stimulation in a n-back task at three specific timepoints during one week
dprime provides the separation between the means of the signal and the noise distributions, compared against the standard deviation of the signal plus noise distributions
Assessment during stimulation in a n-back task at three specific timepoints during one week

Sekundære resultatmål

Resultatmål
Tidsramme
Change of reaction time in n-back task
Tidsramme: Assessment during stimulation in a n-back task at three specific timepoints during one week
Assessment during stimulation in a n-back task at three specific timepoints during one week

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital Tuebingen

Samarbejdspartnere

University Hospital Munich

Efterforskere

  • Ledende efterforsker: Christian Plewnia, Prof., MD, University Hospital Tuebingen, Department of Psychiatry and Psychotherapy

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2015

Primær færdiggørelse (Forventet)

1. august 2022

Studieafslutning (Forventet)

1. oktober 2022

Datoer for studieregistrering

Først indsendt

20. juni 2016

Først indsendt, der opfyldte QC-kriterier

30. juni 2016

Først opslået (Skøn)

6. juli 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 01EE1407H

Plan for individuelle deltagerdata (IPD)

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