Supporting Cognitive Control Training With tDCS
27. september 2019 opdateret af: Christian Plewnia, MD, University Hospital Tuebingen
Lasting Amelioration of Deficient Cognitive Control by Transcranial Direct Current Stimulation (tDCS)-Enhanced Training
Cognitive control (CC) is an important prerequisite for goal-directed behaviour and often associated with dysfunctional prefrontal activity within the cortex.
This can be ameliorated by non-invasive brain stimulation.
In this randomised single-blind study we compare effects of transcranial direct current stimulation (tDCS) on CC in healthy subjects.
The study includes 162 subjects who undergo a two-week (six sessions) training of cognitive control (adaptive paced auditory serial addition task, PASAT) supported by tDCS.
Subjects are randomised to receive either concurrent anodal, cathodal, or sham tDCS with an intensity of 1 mA or 2 mA of their left (F3) or right (F4) PFC, resulting in eight stimulation groups.
Stimulation effects on performance changes are compared to a sham control group.Changes in Affective state are measured by the positive and negative affect schedule (PANAS), possible transfer effects are assessed by the Eriksen Flanker task.
Stability of effects is measured up to three months after the last intervention.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
173
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Tübingen, Tyskland, 72074
- University of Tübingen, Department of Psychiatry and Psychotherapy
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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 40 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy subjects
- Right-handed (assessed by Edinburgh Handedness Inventory)
- No other concurrent brain stimulation during participation
- Proficient in German (min. CEFR level B)
- Ability to strictly adhere to study timeline
Exclusion Criteria:
- Diagnosed neurological illnesses
- Diagnosed psychiatric disorders
- Achromatopsia
- Metallic implants / tattoos on or near electrode sites
- Consumption of tobacco to an equivalent of ten or more cigarettes per day
- Prior participation in experiments involving the PASAT
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: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Sham-komparator: Sham
Sham tDCS (ramp up and ramp down of electrical current before as well as after task performance to elicit physical sensations similar to verum tDCS)
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Added verum or sham tDCS while working on a cognitive control task.
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Aktiv komparator: L1A
Active tDCS
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Added verum or sham tDCS while working on a cognitive control task.
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Aktiv komparator: R1A
Active tDCS
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Added verum or sham tDCS while working on a cognitive control task.
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Aktiv komparator: L2A
Active tDCS
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Added verum or sham tDCS while working on a cognitive control task.
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Aktiv komparator: R2A
Active tDCS
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Added verum or sham tDCS while working on a cognitive control task.
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Aktiv komparator: L1C
Active tDCS
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Added verum or sham tDCS while working on a cognitive control task.
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Aktiv komparator: R1C
Active tDCS
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Added verum or sham tDCS while working on a cognitive control task.
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Aktiv komparator: L2C
Active tDCS
|
Added verum or sham tDCS while working on a cognitive control task.
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Aktiv komparator: R2C
Active tDCS
|
Added verum or sham tDCS while working on a cognitive control task.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Cognitive performance
Tidsramme: 2 to 14 weeks
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Changes in performance in the PASAT (as assessed by number of correct trials within each PASAT session) due to the various tDCS interventions.
All eight interventions will be compared to the sham group.
Cognitive performance is modified by tDCS, which is applied through a multi-channel stimulator (DC-Stimulator MC, NeuroConn GmbH, Ilmenau, Germany; software version 1.3.8;
two rectangular rubber electrodes (5 x 7 cm)).
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2 to 14 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Affective state
Tidsramme: 2 weeks
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Changes in affective state over the course of the experiment (assessed by the positive and negative affect schedule (PANAS) questionnaire).
Scores are calculated for negative and positive affect separately, by summing up the respective answers.
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2 weeks
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Transfer effect
Tidsramme: 3 weeks
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Transfer effects in the Eriksen Flanker task (assessed through mean reaction times).
Means are calculated for congruent, incongruent, and neutral trials respectively.
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3 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Christian Plewnia, MD, University of Tübingen, Department of Psychiatry and Psychotherapy
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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 (Faktiske)
15. april 2016
Primær færdiggørelse (Faktiske)
26. marts 2018
Studieafslutning (Faktiske)
26. marts 2018
Datoer for studieregistrering
Først indsendt
17. september 2019
Først indsendt, der opfyldte QC-kriterier
27. september 2019
Først opslået (Faktiske)
30. september 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. september 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. september 2019
Sidst verificeret
1. september 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- GCBS-WP4
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Uafklaret
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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