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Augmenting rTMS With Cognitive Control Training in Major Depressive Disorder

5. april 2021 opdateret af: Stephan F. Taylor, University of Michigan

Augmenting Repetitive Transcranial Magnetic Stimulation (rTMS) With Cognitive Control Training in Major Depressive Disorder (MDD)

Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for MDD, but the overall effect sized of the treatment is equivalent to antidepressant pharmacotherapy, and responses are highly variable. Given that rTMS is usually given to patients who have failed pharmacotherapy, a more effective alternative is needed.

Therefore, this study will combine computerized cognitive training (CCT) during standard rTMS treatments and assess its feasibility, tolerability, and changes in cognitive control performance and depression symptoms.

Participants that agree to the study and meet eligibility will receive standard rTMS (generally 25-36 daily treatments) along with CCT (starting on day 5 of treatment until the pre-taper treatment). In addition, to CCT participants will be asked to complete assessments before and after treatment

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This project will also have a registry for participants that are approached to be in the clinical trial with the CCT but don't wish to be enrolled. Although the registry will be available for these participants, the information entered into this ClinicalTrials.gov registration will reflect the clinical trial portion of this project.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

4

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan

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 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosis of major depressive disorder
  • Eligible to receive and recommended for rTMS for depression
  • Willingness to complete computerized cognitive training and undergo brain stimulation procedures
  • Must be enrolled as a Michigan Medicine patient and currently receiving TMS treatment as part of your clinical care.

Exclusion Criteria:

  • History of serious neurological illness or brain injury (e.g., stroke)
  • Poor visual acuity impairing performance on the computerized tasks (eyeglasses must be removed for rTMS treatment, but contacts are permissible)
  • Diagnosed intellectual disability
  • Inability to manipulate a tablet device while seated in the rTMS chair

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Computerized Cognitive Training (CCT)
The patients will receive CCT during their standard rTMS treatments (after having 5 days of treatment until the pre-taper treatment).
Andet: Computerized Cognitive Training (CCT)
After having four rTMS sessions without CCT, the patients will perform CCT (starting day 5) during the rTMS session, which typically last from 20-40 minutes. A course of rTMS therapy includes from 25-36 treatments, given daily, until the last 5-6 treatments, given as a 'taper' over 2 weeks. CCT will be paired with rTMS up until the taper begins. In addition, they will have assessments prior to and after the therapy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility assessed by percentage of CCT sessions completed during rTMS
Tidsramme: approximately 30 days (usually 20-30 sessions)
Percentage CCT sessions completed: (number of sessions completed/number of sessions assigned) X 100
approximately 30 days (usually 20-30 sessions)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time on task during treatment
Tidsramme: For each day: 45 min; for entire treatment: approx 30 days
Percentage time on task: (Time engaged with task/total time of task assigned)X100, averaged over all active sessions
For each day: 45 min; for entire treatment: approx 30 days
Acceptability of CCT
Tidsramme: through study completion date, up to 2 years
Percentage: (Number of eligible patients accepting CCT/number of patients approached but not accepting CCT) x 100
through study completion date, up to 2 years
Cognitive Control Performance change over course of treatment
Tidsramme: Approximately 30 days (usually 20-30 sessions)
Average percentage correct trials on n-back working memory task for first 2 sessions minus average percentage correct trials for last 2 sessions.
Approximately 30 days (usually 20-30 sessions)

Samarbejdspartnere og efterforskere

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

Sponsor

University of Michigan

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)

27. august 2019

Primær færdiggørelse (Faktiske)

1. april 2021

Studieafslutning (Faktiske)

1. april 2021

Datoer for studieregistrering

Først indsendt

19. marts 2020

Først indsendt, der opfyldte QC-kriterier

19. marts 2020

Først opslået (Faktiske)

23. marts 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HUM00161598

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

Kliniske forsøg med Større depressiv lidelse

Kliniske forsøg med Computerized Cognitive Training (CCT)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Iran

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner