NCT07599228

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
55mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2031

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

3.1 years

First QC Date

April 28, 2026

Last Update Submit

May 14, 2026

Conditions

Migraine DisordersMigraine With AuraMigraine Without AuraEpisodic Migraine

Keywords

acceptance and commitment therapy (ACT)migrainevirtual realitymindfulnessCalcitonin Gene-Related Peptide monoclonal antibody therapy

Outcome Measures

Primary Outcomes (3)

  • Phase one: Qualitative Interview of User Experience

    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

    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

    6 Months

Secondary Outcomes (3)

  • Phase two: Headache Disability Inventory

    6 Months

  • Phase two: Change in Inflammatory Biomarker panel-NULISAseq Inflammation 250

    baseline and 12 weeks

  • Anxiety and Depression

    baseline and 12 weeks

Study Arms (2)

Treatment as usual

NO INTERVENTION

This group will remain on their CGRP injectable monoclonal antibody migraine preventive medication

Active Treatment

ACTIVE COMPARATOR

This group will participate in the four week active virtual reality treatment and will also remain on their CGRP mAb medication.

Behavioral: ACT therapy delivered by REACT NeuroVR headset

Interventions

ACT therapy delivered by REACT NeuroVR headsetBEHAVIORAL

This is ACT/mindfulness therapy delivered via a virtual reality headset.

Active Treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Brigham and Womens Hospital

Boston, Massachusetts, 02155, United States

Location

Brigham and Women's Health Care Center

Chestnut Hill, Massachusetts, 02467, United States

Location

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location

Related Publications (7)

  • Yamanaka G, Hayashi K, Morishita N, Takeshita M, Ishii C, Suzuki S, Ishimine R, Kasuga A, Nakazawa H, Takamatsu T, Watanabe Y, Morichi S, Ishida Y, Yamazaki T, Go S. Experimental and Clinical Investigation of Cytokines in Migraine: A Narrative Review. Int J Mol Sci. 2023 May 6;24(9):8343. doi: 10.3390/ijms24098343.

    PMID: 37176049BACKGROUND

  • Viderman D, Tapinova K, Dossov M, Seitenov S, Abdildin YG. Virtual reality for pain management: an umbrella review. Front Med (Lausanne). 2023 Jul 14;10:1203670. doi: 10.3389/fmed.2023.1203670. eCollection 2023.

    PMID: 37521355BACKGROUND

  • Thuraiaiyah J, Erritzoe-Jervild M, Al-Khazali HM, Schytz HW, Younis S. The role of cytokines in migraine: A systematic review. Cephalalgia. 2022 Dec;42(14):1565-1588. doi: 10.1177/03331024221118924. Epub 2022 Aug 12.

    PMID: 35962530BACKGROUND

  • R P, S C N, S H, K R. Migraine Disability, Quality of Life, and Its Predictors. Ann Neurosci. 2020 Jan;27(1):18-23. doi: 10.1177/0972753120929563. Epub 2020 Jul 3.

    PMID: 32982095BACKGROUND

  • P AS, S G. Acceptance and Commitment Therapy and Psychological Well-Being: A Narrative Review. Cureus. 2025 Jan 20;17(1):e77705. doi: 10.7759/cureus.77705. eCollection 2025 Jan.

    PMID: 39974259BACKGROUND

  • Musubire AK, Cheema S, Ray JC, Hutton EJ, Matharu M. Cytokines in primary headache disorders: a systematic review and meta-analysis. J Headache Pain. 2023 Apr 4;24(1):36. doi: 10.1186/s10194-023-01572-7.

    PMID: 37016284BACKGROUND

  • Aditya S, Rattan A. Advances in CGRP Monoclonal Antibodies as Migraine Therapy: A Narrative Review. Saudi J Med Med Sci. 2023 Jan-Mar;11(1):11-18. doi: 10.4103/sjmms.sjmms_95_22. Epub 2023 Jan 14.

    PMID: 36909005BACKGROUND

MeSH Terms

Conditions

Migraine DisordersMigraine with AuraMigraine without Aura

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • carolyn bernstein, MD

    BWH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

carolyn bernstein, MD

CONTACT

6177329700cabernstein@bwh.harvard.edu

asimina lazaridou, PhD

CONTACT

alazaridou@bwh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There will be two groups, treatment as usual and active intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lavine Family Endowed Chair in Neurology

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 20, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

January 1, 2031

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
current to completion of final publication, approximately five years
Access Criteria
Only BWH research team will have access to the IPD

Locations

US(3)