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Hjemmebaseret hjernestimuleringsbehandling for postakutte følgesygdomme af COVID-19 (PASC)

9. april 2026 opdateret af: Hamdi Eryilmaz, PhD, Massachusetts General Hospital

Hjemmebaseret transkraniel jævnstrømsstimulering (tDCS) til behandling af kognitive postakutte følgesygdomme af COVID-19 (PASC)

Hovedmålet med denne undersøgelse er at forbedre dyseksekutive symptomer (f.eks. vedvarende opmærksomhed, behandlingshastighed) hos patienter, der udviser postakutte følgesygdomme af COVID-19 (PASC) gennem hjemmebaseret transkraniel jævnstrømsstimulering (tDCS), en ikke-invasiv metode, der bruger lavintensive elektriske strømme leveret til hjernen gennem stimuleringselektroder i hovedbunden.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

31

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
    • Massachusetts
      • Charlestown, Massachusetts, Forenede Stater, 02129
        • Massachusetts General Hospital

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Evne til at give informeret samtykke
  • En diagnose af PASC som indikeret af tidligere COVID-19-infektion og vedvarende symptomer, herunder 'hjernetåge', forvirring, korttidshukommelsessvigt, koncentrationsbesvær, delirium, vanskeligheder med multitasking.

Ekskluderingskriterier:

  • Epilepsis historie
  • Metalliske implantater i hoved og nakke,
  • Hjernestimulatorer
  • Pacemakere
  • Graviditet
  • Afhængighed af aktivt stof (undtagen tobak)
  • Præmorbid større neurologisk sygdom
  • Alvorlig psykisk sygdom (f.eks. bipolar lidelse, skizofreni)
  • Attention Deficit Hyperactivity Disorder

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Aktiv tDCS
Denne gruppe vil modtage daglig aktiv stimulation (2 mA) til venstre dorsolaterale præfrontale cortex i 4 uger gennem en hjemmebaseret tDCS-enhed i fjernovervågede 30-minutters sessioner.
Enhed: Aktiv tDCS
2 mA anodal stimulation vil blive påført den venstre præfrontale cortex over F3-elektroden baseret på det internationale 10-10 EEG-system.
Sham-komparator: Sham tDCS
Denne gruppe vil modtage daglig simuleret stimulation til venstre dorsolaterale præfrontale cortex i 4 uger gennem en hjemmebaseret tDCS-enhed i fjernovervågede 30-minutters sessioner.
Enhed: Sham tDCS
Sham-stimulering vil blive påført den venstre præfrontale cortex over F3-elektroden.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Inhibitory Control
Tidsramme: Baseline
Performance during the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention). The performance is quantified as the ratio of correct responses to all responses. For example, a score of 0.70 indicates that the participant responded to 70% of the trials correctly.
Baseline
Inhibitory Control
Tidsramme: Posttreatment (1 month follow-up)
Performance during the incongruent trials of the Eriksen Flanker Task were assessed approximately approximately 4-weeks after baseline. The performance is quantified as the ratio of correct responses to all responses. For example, a score of 0.70 indicates that the participant responded to 70% of the trials correctly.
Posttreatment (1 month follow-up)
Processing Speed
Tidsramme: Baseline
Reaction time during the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention)
Baseline
Processing Speed
Tidsramme: Posttreatment (1 month follow-up)
Reaction time during the incongruent trials of the Eriksen Flanker Task were assessed approximately 4-weeks after baseline.
Posttreatment (1 month follow-up)
EEG P300 Event-related Potential
Tidsramme: Baseline
EEG P300 amplitudes time-locked to the incongruent trials of the Eriksen Flanker Task were assessed at baseline (before the beginning of the 4-week home tDCS intervention). EEG event-related potential amplitudes (measured in microvolts, µV) were normalized across EEG channels using a scaling procedure, in which each channel was rescaled to reduce variability in signal magnitude among electrodes while preserving temporal and spectral characteristics. While larger P300 amplitudes are typically associated with better cognitive outcomes, this can vary among study populations.
Baseline
EEG P300 Event-related Potential
Tidsramme: Posttreatment (1 month follow-up)
EEG P300 amplitudes time-locked to the incongruent trials of the Eriksen Flanker Task were assessed approximately 4-weeks after baseline. EEG event-related potential amplitudes (measured in microvolts, µV) were normalized across EEG channels using a scaling procedure, in which each channel was rescaled to reduce variability in signal magnitude among electrodes while preserving temporal and spectral characteristics. While larger P300 amplitudes are typically associated with better cognitive outcomes, this can vary among study populations.
Posttreatment (1 month follow-up)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cognitive Flexibility
Tidsramme: Baseline
Performance on the NIH Toolbox Dimensional Change Card Sort Test, a computerized measure of executive function assessing cognitive flexibility, attention, and set-shifting. Participants match target stimuli based on changing rules (e.g., color or shape). Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better cognitive flexibility and executive control.
Baseline
Cognitive Flexibility
Tidsramme: Posttreatment (1 month follow-up)
Performance on the NIH Toolbox Dimensional Change Card Sort Test, a computerized measure of executive function assessing cognitive flexibility, attention, and set-shifting. Participants match target stimuli based on changing rules (e.g., color or shape). Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better cognitive flexibility and executive control.
Posttreatment (1 month follow-up)
Working Memory
Tidsramme: Baseline
Performance on the NIH Toolbox List Sorting Working Memory Test, which assesses working memory capacity through sequencing and recall of visually and verbally presented stimuli in size order. The task requires temporary storage and manipulation of information across increasing list lengths. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better working memory performance.
Baseline
Working Memory
Tidsramme: Posttreatment (1 month follow-up)
Performance on the NIH Toolbox List Sorting Working Memory Test, which assesses working memory capacity through sequencing and recall of visually and verbally presented stimuli in size order. The task requires temporary storage and manipulation of information across increasing list lengths. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better working memory performance.
Posttreatment (1 month follow-up)
Episodic Memory
Tidsramme: Baseline
Performance on the NIH Toolbox Picture Sequence Memory Test, a measure of episodic memory in which participants reproduce the order of a sequence of visually presented pictures. The task assesses the ability to encode, store, and retrieve sequential information. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better episodic memory function.
Baseline
Episodic Memory
Tidsramme: Posttreatment (1 month follow-up)
Performance on the NIH Toolbox Picture Sequence Memory Test, a measure of episodic memory in which participants reproduce the order of a sequence of visually presented pictures. The task assesses the ability to encode, store, and retrieve sequential information. Scores are reported as fully corrected (for age, gender, race/ethnicity, and education) T-scores (mean = 50, SD = 10), with higher scores indicating better episodic memory function.
Posttreatment (1 month follow-up)

Samarbejdspartnere og efterforskere

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

Sponsor

Massachusetts General Hospital

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)

7. juni 2022

Primær færdiggørelse (Faktiske)

13. marts 2025

Studieafslutning (Anslået)

15. juni 2026

Datoer for studieregistrering

Først indsendt

21. oktober 2021

Først indsendt, der opfyldte QC-kriterier

21. oktober 2021

Først opslået (Faktiske)

25. oktober 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. april 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. april 2026

Sidst verificeret

1. november 2025

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2021P002953

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

Ja

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 Dyseksekutivt syndrom

Kliniske forsøg med Aktiv tDCS

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Sponsorer og samarbejdspartnere

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Narkotikainterventioner

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CROs in New Zealand

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner