Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Focused Ultrasound for Behavioral Health (VANTUS)

23. oktober 2026 opdateret af: Attune Neurosciences Inc

Bayesian-Optimized Dose-Finding of ATTN201 Focused Ultrasound for Behavioral Health

This is a double-blind, within-participant crossover, multi-site dose-finding study evaluating the safety, feasibility, and preliminary efficacy of repeated low-intensity focused ultrasound (LIFU) stimulation using the ATTN201 device across seven candidate deep-brain targets in adults with subsyndromal-to-moderate depression, anxiety, or obsessive-compulsive disorder. Every session delivers active ATTN201 stimulation; there is no sham or placebo condition. Participants and the on-site study staff who deliver stimulation and administer the clinical scales are blinded to the brain target and to the stimulation parameters assigned for each session by a constrained Bayesian optimization algorithm.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

Following a remote pre-screen and an in-person screening/baseline visit (Visit 0), at which informed consent is obtained, eligibility is confirmed, baseline clinical scales are administered, optional biospecimens are collected from participants who consent to them, a multi-sequence brain MRI is acquired for targeting, and monitoring devices are fitted, each participant receives between 3 and 10 ATTN201 stimulation sessions spaced approximately 7 days apart. Each stimulation visit serves as the pre-stimulation baseline for that session, the 1-week post-stimulation measurement for the prior session, and the 2-week post-stimulation measurement for the session before that. A platform-administered scale battery at day 7 after the last stimulation captures the 1-week measurement for the final session; a remote final treatment-period follow-up approximately 2 weeks after the last stimulation captures the 2-week measurement. A remote 3-month post-treatment check-in captures durability and any delayed adverse events.

The trial uses a two-stage architecture. In Stage 1, visits are allocated across all seven candidate targets. After approximately 300 visits, the Sponsor and ARPA-H convene a joint review and select 3-5 targets for continued Bayesian optimization in Stage 2.

Monitoring during enrollment includes validated clinical scales (PHQ-9, GAD-7, OCI-R) at baseline, before each stimulation visit, at the final treatment-period follow-up, and at the 3-month follow-up; transdiagnostic visual analog scales, a morning sleep diary, and brief voice recordings prompted through the Attune platform during monitoring blocks; optional nightly ambulatory EEG; and a smart watch worn from Visit 0 through device return. All scheduled platform prompts are voluntary at the individual-prompt level.

Blinding: A single on-site research associate positions the device, runs the stimulation session, and administers participant-facing assessments, and is blinded to the brain target and parameter combination; this individual occupies both the care provider and the outcomes assessor role. The stimulation condition is selected by the Bayesian optimization algorithm and pushed to the device as a sealed session. The Lead Principal Investigator and the optimization team are unblinded as required to operate the adaptive design and do not deliver stimulation or administer participant-facing assessments. The independent Medical Monitors and the Data Safety and Monitoring Board receive unblinded safety data.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
300

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94107
        • Ikke rekrutterer endnu
        • Attune Neurosciences, Inc.
      • San Francisco, California, Forenede Stater, 94107
        • Rekruttering
        • Attune, San Francisco Clinical Research Center
        • Kontakt:
        • Ledende efterforsker:
          • Keith Murphy, PhD

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

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

22 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Be between 22 and 80 years of age (inclusive) on the day of signing informed consent.
  • Have at least one of the following at screening: PHQ-9 total score 5-16 (depression), GAD-7 total score 5-14 (anxiety), or OCI-R total score 14-27 (obsessive-compulsive disorder).
  • If currently taking psychiatric medication, have been on the same stable dose(s) for at least 4 weeks prior to screening and be willing to maintain the regimen throughout the treatment period.
  • Be able and willing to undergo a multi-sequence cranial MRI.
  • Be willing to use the ATTN201 device during stimulation visits and to attempt use of monitoring devices (optional ambulatory EEG system, smart watch) during the pre- and post-stimulation monitoring blocks; use of the optional ambulatory EEG system does not affect eligibility.
  • Sign the informed consent form, in accordance with local requirements, after the scope and nature of the investigation have been explained to the participant, and before any screening assessments.
  • Be able to speak, read, and understand English.
  • Be able to use a smartphone and the Attune platform.
  • Possess the ability to respond verbally to questions, follow instructions, and complete study assessments.
  • Be able to adhere to the treatment protocol and visit schedules through the 3-month post-treatment follow-up.
  • Be judged by the investigator as likely to comply with study procedures and willing to participate in the entirety of the study.
  • Be determined by the investigator to be medically stable at baseline as assessed by medical history and non-significant clinical results of a vital signs examination.
  • Male participants must ensure a condom is used for all sexual intercourse and follow acceptable methods of contraception for their female partner for the entire duration of the study and for 90 days after the final study visit. Male participants should not father a child or donate sperm during this same period.
  • Female participants who are sexually active agree to use two methods of contraception for the duration of the study and for 30 days after the final study visit, or not be of childbearing potential as indicated by natural menopause (≥12 consecutive months of spontaneous amenorrhea), hysterectomy, bilateral tubal ligation, bilateral oophorectomy (with or without hysterectomy) more than 6 weeks prior to screening, or a vasectomized partner with documented absence of sperm.

Exclusion Criteria:

  • Columbia Suicide Severity Rating Scale (C-SSRS) score ≥ 3 (ideation with intent, with or without plan) at screening.
  • Any suicide attempt within the past 12 months.
  • Any change in psychiatric medication (start, stop, or dose change) within 4 weeks prior to screening.
  • Has an unstable or severe medical or psychiatric condition that, in the investigator's judgment, would pose a safety risk to the participant or prevent completion of study procedures. Stable comorbid conditions (e.g., treated depression, anxiety, OCD, insomnia) within the protocol-specified score windows are permitted.
  • Has an active, unstable substance use disorder including alcohol use disorder in the past 6 months (except for caffeine and nicotine). Participants on stable medication-assisted treatment (e.g., buprenorphine, methadone, naltrexone) for at least 6 months are eligible.
  • Has a history of moderate-to-severe traumatic brain injury, or mild traumatic brain injury within the past 12 months.
  • Has a history of seizure disorder or epilepsy, or any structural CNS lesion known to lower seizure threshold.
  • Has any contraindications for completing a brain MRI scan (e.g., pacemaker, ferromagnetic implants).
  • Body mass index (BMI) greater than 40 kg/m².
  • Is pregnant, is attempting to become pregnant, or is nursing.
  • Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is an investigational site or Sponsor staff member directly involved with this trial.
  • Has a known allergy or sensitivity to ultrasound gel, silicone, or adhesive materials used in monitoring devices.
  • Has an active skin condition at sensor placement sites that would prevent device wear.
  • Has received an investigational drug or device in another clinical study within 30 days before screening

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: Ikke-randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Basolateral amygdala (BLA)

ATTN201 head-worn low-intensity focused ultrasound delivered to the basolateral amygdala (BLA). Sessions at which the constrained Bayesian optimization algorithm assigns this target; stimulation parameters (pulse repetition frequency, duty cycle, target pressure) vary within the ITRUSST-bounded search space. Participants may cross over to other target arms at subsequent sessions.
Enhed: ATTN201 head-worn focused ultrasound

ATTN201 head-worn focused ultrasound
Eksperimentel: Dorsal anterior cingulate cortex (dACC)

ATTN201 head-worn low-intensity focused ultrasound delivered to the dorsal anterior cingulate cortex (dACC). Sessions at which the constrained Bayesian optimization algorithm assigns this target; stimulation parameters (pulse repetition frequency, duty cycle, target pressure) vary within the ITRUSST-bounded search space. Participants may cross over to other target arms at subsequent sessions.
Enhed: ATTN201 head-worn focused ultrasound

ATTN201 head-worn focused ultrasound
Eksperimentel: Anterior limb of internal capsule (ALIC)

ATTN201 head-worn low-intensity focused ultrasound delivered to the anterior limb of the internal capsule (ALIC). Sessions at which the constrained Bayesian optimization algorithm assigns this target; stimulation parameters (pulse repetition frequency, duty cycle, target pressure) vary within the ITRUSST-bounded search space. Participants may cross over to other target arms at subsequent sessions.
Enhed: ATTN201 head-worn focused ultrasound

ATTN201 head-worn focused ultrasound
Eksperimentel: Centromedian nucleus of thalamus (CMN)

ATTN201 head-worn low-intensity focused ultrasound delivered to the centromedian nucleus of the thalamus (CMN). Sessions at which the constrained Bayesian optimization algorithm assigns this target; stimulation parameters (pulse repetition frequency, duty cycle, target pressure) vary within the ITRUSST-bounded search space. Participants may cross over to other target arms at subsequent sessions.
Enhed: ATTN201 head-worn focused ultrasound

ATTN201 head-worn focused ultrasound
Eksperimentel: Rostral zona incerta (rZi)

ATTN201 head-worn low-intensity focused ultrasound delivered to the rostral zona incerta (rZi). Sessions at which the constrained Bayesian optimization algorithm assigns this target; stimulation parameters (pulse repetition frequency, duty cycle, target pressure) vary within the ITRUSST-bounded search space. Participants may cross over to other target arms at subsequent sessions.
Enhed: ATTN201 head-worn focused ultrasound

ATTN201 head-worn focused ultrasound
Eksperimentel: Subthalamic nucleus (STN)

ATTN201 head-worn low-intensity focused ultrasound delivered to the subthalamic nucleus (STN). Sessions at which the constrained Bayesian optimization algorithm assigns this target; stimulation parameters (pulse repetition frequency, duty cycle, target pressure) vary within the ITRUSST-bounded search space. Participants may cross over to other target arms at subsequent sessions.
Enhed: ATTN201 head-worn focused ultrasound

ATTN201 head-worn focused ultrasound
Eksperimentel: Anterior nucleus of thalamus (ANT)

ATTN201 head-worn low-intensity focused ultrasound delivered to the anterior nucleus of the thalamus (ANT). Sessions at which the constrained Bayesian optimization algorithm assigns this target; stimulation parameters (pulse repetition frequency, duty cycle, target pressure) vary within the ITRUSST-bounded search space. Participants may cross over to other target arms at subsequent sessions.
Enhed: ATTN201 head-worn focused ultrasound

ATTN201 head-worn focused ultrasound

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient-specific transdiagnostic score (TDx) at 1 week after stimulation
Tidsramme: 1 week after each stimulation session

TDx measured 1 week after each stimulation session. The TDx is a severity-weighted composite of normalized improvement on PHQ-9, GAD-7, and OCI-R; higher TDx indicates greater improvement.
1 week after each stimulation session

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient-specific transdiagnostic score (TDx) at 2 weeks after stimulation
Tidsramme: 2 weeks after each stimulation session

TDx measured 2 weeks after each stimulation session. The TDx is a severity-weighted composite of normalized improvement on PHQ-9, GAD-7, and OCI-R; higher TDx indicates greater improvement.
2 weeks after each stimulation session
Posterior mean transdiagnostic score (TDx) at the best stimulation parameter set for each brain target
Tidsramme: At study completion, up to 19 months

Posterior mean TDx, from a Gaussian process model fit for each brain target, at the stimulation parameter set that maximizes it. TDx is a severity-weighted composite of normalized improvement on PHQ-9, GAD-7, and OCI-R; higher TDx indicates greater improvement.
At study completion, up to 19 months
Change from pre-stimulation baseline in PHQ-9 total score
Tidsramme: Pre-stimulation baseline, 1 week after stimulation, and 2 weeks after stimulation

Change from the local pre-stimulation baseline in Patient Health Questionnaire-9 (PHQ-9) total score. The PHQ-9 is a 9-item self-report measure of depression severity over the preceding 2 weeks. Total score range is 0 to 27; higher scores indicate greater depression severity. A negative change score indicates improvement.
Pre-stimulation baseline, 1 week after stimulation, and 2 weeks after stimulation
Change from pre-stimulation baseline in GAD-7 total score
Tidsramme: Pre-stimulation baseline, 1 week after stimulation, and 2 weeks after stimulation

Change from the local pre-stimulation baseline in Generalized Anxiety Disorder-7 (GAD-7) total score. The GAD-7 is a 7-item self-report measure of anxiety severity over the preceding 2 weeks. Total score range is 0 to 21; higher scores indicate greater anxiety severity. A negative change score indicates improvement.
Pre-stimulation baseline, 1 week after stimulation, and 2 weeks after stimulation
Change from pre-stimulation baseline in OCI-R total score
Tidsramme: Pre-stimulation baseline, 1 week after stimulation, and 2 weeks after stimulation

Change from the local pre-stimulation baseline in Obsessive-Compulsive Inventory-Revised (OCI-R) total score. The OCI-R is an 18-item self-report measure of distress associated with obsessive-compulsive symptoms. Total score range is 0 to 72; higher scores indicate greater symptom severity. A negative change score indicates improvement.
Pre-stimulation baseline, 1 week after stimulation, and 2 weeks after stimulation
Mood visual analog scale (VAS) score
Tidsramme: Daily from Day 1 through Day 7 after each stimulation session

Self-rated mood on a 0-100 continuous VAS administered through the Attune platform; higher scores indicate better mood.
Daily from Day 1 through Day 7 after each stimulation session
Arousal visual analog scale (VAS) score
Tidsramme: Daily from Day 1 through Day 7 after each stimulation session

Self-rated arousal on a 0-100 continuous VAS administered through the Attune platform; higher scores indicate greater arousal.
Daily from Day 1 through Day 7 after each stimulation session
Sleepiness visual analog scale (VAS) score
Tidsramme: Daily from Day 1 through Day 7 after each stimulation session

Self-rated sleepiness on a 0-100 continuous VAS administered through the Attune platform; higher scores indicate greater sleepiness.
Daily from Day 1 through Day 7 after each stimulation session
Anxiety symptom visual analog scale (VAS) score
Tidsramme: Daily from Day 1 through Day 7 after each stimulation session

Self-rated current anxiety symptoms on a 0-100 continuous VAS administered through the Attune platform; higher scores indicate greater anxiety.
Daily from Day 1 through Day 7 after each stimulation session
Obsessive-compulsive symptom visual analog scale (VAS) score
Tidsramme: Daily from Day 1 through Day 7 after each stimulation session

Self-rated current obsessive-compulsive symptoms on a 0-100 continuous VAS administered through the Attune platform; higher scores indicate greater symptom severity.
Daily from Day 1 through Day 7 after each stimulation session
Depression symptom visual analog scale (VAS) score
Tidsramme: Daily from Day 1 through Day 7 after each stimulation session

Self-rated current depression symptoms on a 0-100 continuous VAS administered through the Attune platform; higher scores indicate greater symptom severity.
Daily from Day 1 through Day 7 after each stimulation session
Prefrontal EEG delta band spectral power
Tidsramme: Nightly from Day 1 through Day 7 after each stimulation session

Absolute spectral power in the delta band from nightly two-channel prefrontal ambulatory EEG recordings, among participants who elect optional EEG monitoring.
Nightly from Day 1 through Day 7 after each stimulation session
Prefrontal EEG theta band spectral power
Tidsramme: Nightly from Day 1 through Day 7 after each stimulation session

Absolute spectral power in the theta band from nightly two-channel prefrontal ambulatory EEG recordings, among participants who elect optional EEG monitoring.
Nightly from Day 1 through Day 7 after each stimulation session
Prefrontal EEG alpha band spectral power
Tidsramme: Nightly from Day 1 through Day 7 after each stimulation session

Absolute spectral power in the alpha band from nightly two-channel prefrontal ambulatory EEG recordings, among participants who elect optional EEG monitoring.
Nightly from Day 1 through Day 7 after each stimulation session
Prefrontal EEG beta band spectral power
Tidsramme: Nightly from Day 1 through Day 7 after each stimulation session

Absolute spectral power in the beta band from nightly two-channel prefrontal ambulatory EEG recordings, among participants who elect optional EEG monitoring.
Nightly from Day 1 through Day 7 after each stimulation session
Prefrontal EEG gamma band spectral power
Tidsramme: Nightly from Day 1 through Day 7 after each stimulation session

Absolute spectral power in the gamma band from nightly two-channel prefrontal ambulatory EEG recordings, among participants who elect optional EEG monitoring.
Nightly from Day 1 through Day 7 after each stimulation session
EEG-derived sleep efficiency
Tidsramme: Nightly from Day 1 through Day 7 after each stimulation session

Sleep efficiency (percentage of time in bed spent asleep) derived by automated sleep staging of nightly two-channel prefrontal ambulatory EEG recordings, among participants who elect optional EEG monitoring.
Nightly from Day 1 through Day 7 after each stimulation session
Smart-watch-derived heart rate variability
Tidsramme: Daily from Day 1 through Day 7 after each stimulation session

Daily heart rate variability (milliseconds) recorded by the study smart watch.
Daily from Day 1 through Day 7 after each stimulation session
Smart-watch-derived daily step count
Tidsramme: Daily from Day 1 through Day 7 after each stimulation session

Daily step count (actigraphy) recorded by the study smart watch.
Daily from Day 1 through Day 7 after each stimulation session
Smart-watch-derived sleep duration
Tidsramme: Nightly from Day 1 through Day 7 after each stimulation session

Nightly total sleep duration (minutes) recorded by the study smart watch.
Nightly from Day 1 through Day 7 after each stimulation session
Life-space mobility
Tidsramme: Daily from Day 1 through Day 7 after each stimulation session

Daily life-space mobility (maximum distance from home, kilometers) derived from de-identified GPS collected by the optional Beiwe research application on the participant's smartphone.
Daily from Day 1 through Day 7 after each stimulation session
Patient-specific transdiagnostic score (TDx) at 1 week after stimulation, by primary indication
Tidsramme: 1 week after each stimulation session

TDx measured 1 week after each stimulation session, summarized separately for participants whose primary indication is depression, anxiety, obsessive-compulsive disorder, or comorbid. TDx is a severity-weighted composite of normalized improvement on PHQ-9, GAD-7, and OCI-R; higher TDx indicates greater improvement.
1 week after each stimulation session

Samarbejdspartnere og efterforskere

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

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Attune Neurosciences Inc

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
University of Pennsylvania
University of California, San Francisco

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)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
19. oktober 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
5. april 2028

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
17. maj 2028

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
28. august 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
24. september 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
1. oktober 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
27. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
23. oktober 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • Pro00095585

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data will be deposited into the ARPA-H designated data repository as required by the funded ARPA-H EVIDENT program. Deposited data include clinical outcome measures (PHQ-9, GAD-7, OCI-R, PROMIS Sleep Disturbance 8a, PROMIS Sleep-Related Impairment 8a, DASS-8, Brief Resilience Scale, Flourishing Scale, and transdiagnostic visual analog scales), delivered stimulation parameters, EEG-derived and wearable-derived biomarker measures, platform-derived measures, relevant metadata, and optional baseline dried blood spot and saliva biospecimens where collected. Participant identifiers are not included in deposited datasets.

IPD-delingstidsramme

Deposits occur on rolling quarterly delivery cycles beginning after enrollment of the first participant and continuing through study completion. Deposited data remain available thereafter under the retention terms of the ARPA-H designated data repository.

IPD-delingsadgangskriterier

Access is governed by the data access procedures of the ARPA-H designated data repository. Requests for deposited data are made to the repository rather than to the sponsor.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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 .

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