- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07718906
Neuromodulation for Behavioral Changes in Neurological Disorders
16. juli 2026 opdateret af: Ali Rezai, West Virginia University
A Prospective Early Feasibility Study of Focused Ultrasound Neuromodulation for Emotional Dysregulation Due to Dementia.
The purpose of this study is to see if a focused ultrasound neuromodulation can be safely and effectively used to treat symptoms of emotional dysregulation such as agitation, irritability and anxiety
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This open-label early feasibility study investigates low intensity focussed ultrasound (FUS), in participants with emotional dysregulation due to dementia.
The primary objective is to test the safety and feasibility of FUS in this population.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
15
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jennifer Marton, BA
- Telefonnummer: 304-293-5886
- E-mail: jmarton@hsc.wvu.edu
Undersøgelse Kontakt Backup
- Navn: Marc Haut, PhD
- Telefonnummer: 304-293-8182
- E-mail: mhaut@hsc.wvu.edu
Studiesteder
-
-
West Virginia
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Morgantown, West Virginia, Forenede Stater, 26505
- WVU Rockefeller Neuroscience Institute
-
Underforsker:
- Marc Haut, PhD
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Kontakt:
- Victor Finomore, PhD
- Telefonnummer: 3042760500
- E-mail: vfinomore@hsc.wvu.edu
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Kontakt:
- Padma Tirumalai, PhD
- Telefonnummer: 3042760500
- E-mail: ptirumalai@hsc.wvu.edu
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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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
- Age 45-80 years at time of enrollment.
- Diagnosis of probable mild-stage neurodegenerative dementia, including Alzheimer's disease (AD), frontotemporal dementia (FTD, including behavioral variant and language variant), or dementia with Lewy bodies (LBD), based on established consensus clinical criteria.
- Presence of clinically meaningful (in treatment for or recommended for the symptoms) neuropsychiatric or behavioral symptoms including but not limited to anxiety, agitation, depression, irritability, apathy, or disinhibition
- Able to undergo MRI scanning
- Adequate auditory and visual abilities to complete study procedures as determined by the investigator.
- Availability of a study partner (legally authorized representative, caregiver, or family member) who has regular contact with the participant and can provide collateral information and assist with assessments.
- Ability to provide informed consent, or assent with legally authorized representative (LAR) consent in accordance with WVU IRB policy and applicable West Virginia law. .Currently under the care of a licensed physician, psychiatrist, or neurologist, and agrees to allow communication between investigators/study staff and healthcare providers for purposes of eligibility confirmation and safety monitoring.
EXCLUSION CRITERIA
- Moderate to severe dementia (i.e., beyond mild stage).
- Clinically significant MRI abnormality that may jeopardize participant safety, study conduct, or confound diagnostic assessments.
- History of clinically significant neurological disorder other than the qualifying dementia diagnosis that could confound evaluation or increase risk.
- Major psychiatric disorder that would interfere with participation or safety, including psychosis, active suicidal ideation, or severe mood/anxiety disorder requiring immediate intervention.
- Elevated suicide risk with History of medically verified suicide attempt within the past year.
- Use of medications that significantly lower the seizure threshold or interfere with neuromodulation safety, as determined by the study physician.
- Use of investigational drugs or participation in another interventional clinical trial within 30 days prior to screening.
- Any condition that, in the opinion of the investigator, would interfere with study participation, safety, or interpretation of results.
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Treatment
FUS Neuromodulation
|
Subjects will undergo a single focused ultrasound Neuromodulation of the target brain region
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Occurrence of Treatment Emergent Adverse Events
Tidsramme: Week 12 compared to baseline
|
All adverse events that are related to FUS treatment will be assessed
|
Week 12 compared to baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in behavioral symptoms
Tidsramme: Week 12 compared to baseline
|
Change in behavioral symptoms as assessed by NPI
|
Week 12 compared to baseline
|
|
Changes in Anxiety symptoms
Tidsramme: Week 12 compared to baseline
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Changes in Anxiety symptoms as measured by GAD-7
|
Week 12 compared to baseline
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ali Rezai, WVU Rockefeller Neuroscience Institute
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 (Anslået)
25. juli 2026
Primær færdiggørelse (Anslået)
30. december 2027
Studieafslutning (Anslået)
30. december 2028
Datoer for studieregistrering
Først indsendt
13. juli 2026
Først indsendt, der opfyldte QC-kriterier
16. juli 2026
Først opslået (Faktiske)
22. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RNI_NMD_EDR
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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-
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