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Non-invasive Stimulation of Deep Brain Structures to Modulate Working Memory (DEEPBRAIN)

28. april 2026 opdateret af: Monika Pupikova, Masaryk University

A study investigating the effects of non-invasive electrical stimulation of deep brain structures on working memory, attention, and executive functions involved in everyday activities. Currently, there is no effective treatment for impairments in these functions. The study will evaluate the effects of non-invasive electrical stimulation in both healthy older adults and individuals with mild impairment of these functions.

The study combines magnetic resonance imaging (MRI) with non-invasive brain stimulation targeting deep brain structures. Its aim is to improve understanding of the neural mechanisms underlying these cognitive functions and their impairments, as well as to explore the mechanisms of non-invasive brain stimulation for potential future therapeutic applications.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • normal cognitive performance as assessed by a cognitive screening for healthy subjects
  • possible or probable MCI-LB or with PD-MCI, collectively called MCI-LBD, described as: presence of PD , and level II criteria for MCI (i.e. based on comprehensive neuropsychological examination), or the level II criteria for MCI , and at least two of four core DLB features including parkinsonism, visual hallucinations, attention/cognitive function fluctuation, and REM sleep behavioral disorder, or at least 1 core clinical feature and 1 indicative biomarker (probable MCI-LB).

Exclusion Criteria:

  • Psychiatric disorders including major depression, major vascular lesions, or other brain pathologies that might present with cognitive decline.

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 20 Hz striatal stimulation
Striatum will be targeted by using two pairs of high-frequency tES with a low-frequency offset (20 Hz), creating an interference hotspot targeting the deep brain structure (deep-tES).
Andet: Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (20 Hz)
Striatum will be targeted by using at least two pairs of high-frequency tES with a low-frequency (20 Hz) offset, creating an interference hotspot targeting the deep brain structure (deep-tES).
Eksperimentel: 60 Hz striatal stimulation
Striatum will be targeted by using two pairs of high-frequency tES with a low-frequency offset (60 Hz), creating an interference hotspot targeting the deep brain structure (deep-tES).
Andet: Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (60 Hz)
Striatum will be targeted by using at least two pairs of high-frequency tES with a low-frequency (60 Hz) offset, creating an interference hotspot targeting the deep brain structure (deep-tES).
Sham-komparator: Sham striatal stimulation
Striatum will be targeted by using two pairs of high-frequency tES with no low-frequency offset. The stimulation will be applied only shortly and turned off after ramp-up and ramp-down period.
Andet: Control striatal stimulation
A high-frequency tES without low-frequency offset. It will consist of two oscillatory high-frequency currents without any frequency shifts, which induces similar skin sensations as deep-tES and will be applied just for a ramp-up/ramp-down phases at the beginning of the stimulation and afterwards will be switched off.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The neural underpinning of NIBS-induced changes quantified by task-fMRI activations
Tidsramme: During intervention ( approximately 10 minutes)
During intervention ( approximately 10 minutes)
The neural underpinning of NIBS-induced changes quantified by network-based analytical approaches.
Tidsramme: During intervention ( approximately 10 minutes)
During intervention ( approximately 10 minutes)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Working memory performance - Reaction times
Tidsramme: During intervention (approx 10 minutes)
Reaction times of an N-back task between the real and sham stimulation condition in a cross-over design.
During intervention (approx 10 minutes)
Working memory parformance - Accuracy
Tidsramme: During intervention ( approximately 10 minutes)
Accuracy (measured as D-prime) of an N-back task between the real and sham stimulation condition in a cross-over design.
During intervention ( approximately 10 minutes)

Samarbejdspartnere og efterforskere

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

Sponsor

Masaryk University

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)

1. marts 2026

Primær færdiggørelse (Anslået)

1. juli 2026

Studieafslutning (Anslået)

1. juli 2026

Datoer for studieregistrering

Først indsendt

21. april 2026

Først indsendt, der opfyldte QC-kriterier

28. april 2026

Først opslået (Faktiske)

1. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NW25-04-00142

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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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 Mild kognitiv svækkelse (MCI)

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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