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Using Virtual Reality to Teach Mindfulness to People With Migraine (MIRAGE)

25. august 2026 oppdatert av: Carolyn A. Bernstein, Brigham and Women's Hospital

Migraine Intervention Using Reality-Assisted Guided Experience

The aim of this clinical trial is to learn if people with migraine can learn a type of biobehavioral therapy called Acceptance and Commitment Therapy (ACT) by using a virtual reality headset. Researchers are studying if this type of mindfulness therapy helps to decrease migraine-related disability. Participants will be randomized to treatment as usual or active virtual reality groups for four weeks. Everyone will keep symptom diaries, complete surveys, attend two clinic visits, and have two blood draws.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This study is designed to evaluate the clinical utility of REACT NeuroVR in patients with episodic migraine who are already receiving stable CGRP monoclonal antibody therapy. By combining pharmacologic advances with digitally delivered psychological support, we aim to assess whether this integrated approach can further reduce headache frequency, improve migraine-specific quality of life, and reduce anticipatory anxiety. Additionally, we will explore changes in inflammatory biomarkers to examine potential physiologic correlates of intervention-related improvement.

Ultimately, this study addresses a critical gap in migraine care: the integration of effective, accessible behavioral health strategies into the treatment paradigm for patients who continue to experience burdensome symptoms despite preventive therapy.

1. Specific Aims and Objectives

Aim 1 (Pilot and Feasibility Study):

To evaluate the feasibility, acceptability, and usability of personalized Acceptance and Commitment Therapy (ACT) delivered via REACT NeuroVR. Focus groups with key stakeholders (patients, clinicians, and implementation experts) will be conducted to obtain feedback on intervention content, delivery, and outcome measures. Insights from this pilot phase will inform refinements to the intervention and study procedures for the subsequent full-scale clinical trial.

Aim 2 (Primary Efficacy Aim):

To determine whether personalized ACT therapy delivered via REACT NeuroVR reduces the number of monthly headache days in patients with episodic migraine compared to baseline.

Aim 3 (Psychological and Functional Outcomes):

To evaluate whether REACT NeuroVR improves migraine-specific quality of life and reduces anticipatory anxiety related to migraine events.

Aim 4 (Exploratory Biological and Sensory Aims):

To explore changes in inflammatory biomarkers.

Participants will:

Be randomized to treatment as usual or active VR participants Everyone who completes run-in will have a chance to try the VR device and have an additional screen.

Everyone will have a blood test at the beginning and the end of the study. Active participants will be loaned a VR device to take home for four weeks and will do the study activities as well as use a variety of experiences when they choose (such as beach visits, virtual ice baths and others) Participants will fill out surveys throughout the study.

Visit the clinic twice during the study Keep a diary of their symptoms and number of migraines

Studietype

Intervensjonell

Registrering (Antatt)

160

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02155
        • Brigham and Womens Hospital
      • Chestnut Hill, Massachusetts, Forente stater, 02467
        • Brigham and Women's Hospital
      • Chestnut Hill, Massachusetts, Forente stater, 02467
        • Brigham and Women's Health Care Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Adults aged 18-80
  • Diagnosed with episodic migraine and experience 4-10 migraine days/month
  • On a stable dose of CGRP mAb for three months prior
  • Satisfy 4 week run-in of 4-10 headaches/month
  • Not taking other preventive medications
  • Not pregnant, breastfeeding, or planning to become pregnant within study timeframe
  • Able and willing to use VR device
  • No history of significant psychiatric illness
  • Willing to comply with study procedures
  • English-speaking

Exclusion Criteria:

  • Medication overuse (>10 days/month)
  • Vertigo/vestibular dysfunction
  • Active psychiatric or neurological comorbidities
  • Pregnancy, breastfeeding or planning pregnancy within study timeframe
  • Significant visual/hearing/mobility impairment affecting VR use

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Treatment as usual
This group will remain on their CGRP injectable monoclonal antibody migraine preventive medication
Aktiv komparator: Active Treatment
This group will participate in the four week active virtual reality treatment and will also remain on their CGRP mAb medication.
Atferdsmessig: ACT therapy delivered by REACT NeuroVR headset
This is ACT/mindfulness therapy delivered via a virtual reality headset.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Phase one: Qualitative Interview of User Experience
Tidsramme: 2 weeks
Assessment of user experience captured using open ended questions, yes/no questions, and a 4-point scale ranging from "Very Poor" to "Very Good".
2 weeks
Phase one: rate of participants using virtual reality for migraine-- qualitative data
Tidsramme: 2 weeks
Assessment of how often and how long participants used the devices. Two 6-point scales included ranging from "Never" to "12-14 days" as well as "Under 10 minutes" to "More than 2 hours".
2 weeks
Phase two: Efficacy as described by number of headache days
Tidsramme: 6 Months
6 Months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Phase two: Headache Disability Inventory
Tidsramme: 6 Months
Assessment of acceptance and commitment (ACT) treatment on migraine-associated disability
6 Months
Phase two: Change in Inflammatory Biomarker panel-NULISAseq Inflammation 250
Tidsramme: baseline and 12 weeks
Will be measuring serum samples prior to study and at 12-week time to assess for change
baseline and 12 weeks
Anxiety and Depression
Tidsramme: baseline and 12 weeks
Migraine related anxiety and depression will be assessed by PROMIS29
baseline and 12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Brigham and Women's Hospital

Etterforskere

  • Hovedetterforsker: carolyn bernstein, MD, BWH

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

24. august 2026

Primær fullføring (Antatt)

1. august 2029

Studiet fullført (Antatt)

1. januar 2031

Datoer for studieregistrering

Først innsendt

28. april 2026

Først innsendt som oppfylte QC-kriteriene

14. mai 2026

Først lagt ut (Faktiske)

20. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026P000879

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

We will share demographics including age and sex within the BWH researchers.

IPD-delingstidsramme

current to completion of final publication, approximately five years

Tilgangskriterier for IPD-deling

Only BWH research team will have access to the IPD

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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