A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine
INSeRT
Feasibility of Home-based Immersive Neurofeedback Self-regulation Training (INSeRT) for Youth With Migraine
2 other identifiers
interventional
38
1 country
1
Brief Summary
The goal of this clinical trial is to learn whether a home-based virtual reality (VR) neurofeedback program is feasible and acceptable for adolescents with migraine. The study will also explore whether the program may improve headache-related outcomes. The main questions it aims to answer are: Is it feasible to enroll, randomize, and retain adolescents with migraine in this study? Do participants complete the VR sessions and study procedures as intended? Are there preliminary signals that the VR neurofeedback program may improve headache-related disability and symptoms? Researchers will compare Immersive Neurofeedback Self-Regulation Training (INSeRT), which uses brain activity recorded from a wearable electroencephalogram (EEG) headband to guide the VR experience, to a comparison VR program that presents immersive imagery without neurofeedback or guided relaxation training. Participants will: Complete a 4-week baseline period that includes headache logs, questionnaires, and a laboratory EEG assessment Be randomly assigned to one of two VR programs Complete VR sessions at home three times per week for 4 weeks Complete questionnaires at the end of treatment and again approximately 3 months later Repeat the laboratory EEG assessment at the end of treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2026
CompletedFirst Posted
Study publicly available on registry
March 6, 2026
CompletedStudy Start
First participant enrolled
May 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2028
June 3, 2026
June 1, 2026
2.1 years
February 18, 2026
June 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Feasibility of Recruitment and Enrollment
Recruitment feasibility will be assessed by the number of participants screened and enrolled per month and the proportion of eligible participants who consent to participate.
From study initiation through completion of enrollment (approximately 24 months)
Feasibility of Randomization and Treatment Initiation
Proportion of enrolled participants who complete the baseline/run-in phase, are successfully randomized, and complete the initial intervention training call prior to starting treatment.
From enrollment through completion of pre-treatment preparation phase (approximately 6 weeks after enrollment)
Treatment Credibility (Child-Adapted Credibility/Expectancy Questionnaire - Credibility Subscale)
Adapted 3-item Credibility scale derived from the Credibility/Expectancy Questionnaire (CEQ), modified for developmental appropriateness for youth ages 10-16. Items rated on a 5-point Likert scale; higher scores indicate greater perceived treatment credibility.
Pre-treatment
Percent of Prescribed Virtual Reality Sessions Completed
Adherence to the virtual reality intervention measured as the percent of prescribed sessions completed during the 4-week intervention phase. Participants were prescribed 3 sessions per week for 4 weeks (12 total sessions). Percent adherence will be calculated as: (number of completed sessions ÷ 12) × 100, based on portal-derived usage analytics. Higher values indicate greater adherence.
During the 4-week intervention phase
Mean Duration of Virtual Reality Sessions
Adherence to the virtual reality intervention measured as the average duration (in minutes) of completed VR sessions during the 4-week intervention phase, based on portal-derived usage analytics. Higher values indicate longer session engagement.
During the 4-week intervention phase
Cybersickness Symptoms Questionnaire (CSQ-VR) Mean Total Score
Cybersickness symptoms will be assessed using a child-adapted version of the Cybersickness Symptoms Questionnaire in Virtual Reality (CSQ-VR). Participants rate the extent to which they experienced symptoms such as nausea, dizziness, visual discomfort, and imbalance during or after VR sessions on a 1 to 5 scale (1 = Not at all, 5 = A lot). Item scores will be averaged to create a mean total score, with higher scores indicating greater cybersickness symptoms. Spontaneously reported adverse events will also be recorded in the study adverse event log and summarized descriptively as an indicator of treatment tolerability.
Post-treatment survey window (Day 72 through Day 86 after baseline)
Child-Adapted System Usability Scale (SUS) Total Score
A child-adapted version of the System Usability Scale (SUS) will be used to assess perceived usability of the virtual reality system. The SUS is a 10-item self-report questionnaire rated on a 5-point Likert scale (Strongly Disagree to Strongly Agree). Scores are calculated using standard SUS scoring procedures and transformed to a total score ranging from 0 to 100, with higher scores indicating greater perceived usability.
Post-treatment survey window (Day 72 through Day 86 after baseline)
Retention Through 3-Month Follow-Up
Proportion of randomized participants who complete the 3-month follow-up questionnaires and diary collection period.
Up to approximately 162 days after baseline/enrollment
Secondary Outcomes (7)
Change in Pediatric Migraine Disability Assessment (PedMIDAS) Score (30-day)
Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)
Change in Headache Frequency
Baseline 4-week run-in period compared to 3-month follow-up diary period (approximately 90-118 days after completion of the 4-week treatment phase).
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety T-Score (8-Item Short Form)
Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression T-Score (8-Item Short Form)
Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)
Change in Perceived Stress Scale (PSS-10) Total Score
Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase).
- +2 more secondary outcomes
Other Outcomes (3)
Change in Resting EEG State EEG Spectral Power
Baseline to post-treatment EEG assessment window (approximately Day 72 + 21 days from baseline)
Changes in Movement-Related EEG Spectral Power During Finger-Tapping Task
Baseline to post-treatment EEG assessment window (approximately Day 72 + 21 days from baseline)
Changes in Finger-Tapping Reaction Time
Baseline to post-treatment EEG assessment window (approximately Day 72 + 21 days from baseline)
Study Arms (2)
Immersive Neurofeedback Self-Regulation Training (INSeRT)
EXPERIMENTALParticipants receive a home-based immersive virtual reality intervention that integrates real-time EEG signals from a wearable headband to provide neurofeedback during virtual reality sessions. Sessions are completed three times per week for approximately 8 minutes per session over 4 weeks.
Virtual Reality Imagery (No Neurofeedback)
ACTIVE COMPARATORParticipants receive a home-based immersive virtual reality imagery experience without neurofeedback and without guided relaxation training. Sessions are completed three times per week for approximately 8 minutes per session over 4 weeks.
Interventions
A home-based behavioral intervention that integrates real-time EEG signals from a wearable headband into a virtual reality environment to provide neurofeedback during brief self-regulation training sessions. Participants complete sessions three times per week for approximately 8 minutes per session over 4 weeks.
A home-based virtual reality imagery experience delivered without neurofeedback or guided relaxation training. Participants complete sessions three times per week for approximately 8 minutes per session over 4 weeks.
Eligibility Criteria
You may qualify if:
- Age 10-16 years (inclusive)
- Diagnosis of migraine (with or without aura, or chronic migraine) by a qualified headache specialist
- At least 4 migraine headaches per month
- Presence of headache-free periods between migraine episodes
You may not qualify if:
- Significant physical, psychiatric, or developmental conditions that would limit ability to participate in study procedures
- Clinically elevated Pediatric Vestibular Symptoms Questionnaire (PVSQ) score (\>0.68) or new/worsening vestibular symptoms prior to randomization
- Initiation of a new migraine preventive medication within 4 weeks prior to randomization
- Current participation in behavioral treatment for migraine (e.g., cognitive behavioral therapy or biofeedback)
- History of epilepsy or photosensitive seizures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Mercy
Kansas City, Missouri, 64108, United States
Related Publications (1)
Connelly M, Boorigie M, McCabe K. Acceptability and Tolerability of Extended Reality Relaxation Training with and without Wearable Neurofeedback in Pediatric Migraine. Children (Basel). 2023 Feb 9;10(2):329. doi: 10.3390/children10020329.
PMID: 36832458BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark A Connelly, PhD
Children's Mercy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants are not masked because assignment is apparent based on the specific treatment materials the participant is provided. Randomization is implemented using coded group labels. Investigators, care providers, and outcome assessors remain blinded to allocation. A designated research assistant responsible for distributing intervention materials is unblinded and does not conduct outcome assessments or analyses.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
February 18, 2026
First Posted
March 6, 2026
Study Start
May 13, 2026
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
May 31, 2028
Last Updated
June 3, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data will be made available no later than the time of publication of the primary study results or by the end of the NIH-funded project period, whichever occurs first, and will remain available for at least 10 years following project completion.
- Access Criteria
- De-identified datasets and supporting materials will be publicly available via NIH-compliant repositories. Requests for raw EEG data will require a methodologically sound proposal and execution of a data use agreement in accordance with institutional and NIH policies.
De-identified individual participant data underlying published results will be shared. This includes summary-level questionnaire scores, clinical and demographic variables, intervention usage metrics, and processed EEG data suitable for spectral and event-related potential analyses. Associated data dictionaries, analytic code, and study documentation will also be made available. Raw EEG data will be available upon reasonable request to qualified investigators under appropriate data use agreements.