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

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

Study Overview

• Status: Recruiting
• Conditions: Migraine; Headache Disorders, Primary
• Intervention / Treatment: Behavioral: Immersive Neurofeedback Self-Regulation Training (INSeRT); Behavioral: Virtual Reality Imagery (No Neurofeedback)

Detailed Description

Migraine is a prevalent neurological disorder in children and adolescents and is associated with increasing disability, school impairment, and healthcare utilization during development. Altered cortical excitability has been hypothesized to contribute to migraine vulnerability in youth. Neurofeedback interventions are designed to facilitate self-regulation of neural activity; however, traditional neurofeedback approaches are often clinic-based, difficult for families to access consistently, and have limited pediatric-specific outcome data.

This study evaluates the feasibility of Immersive Neurofeedback Self-Regulation Training (INSeRT) in adolescents aged 10-16 years diagnosed with migraine. INSeRT is a home-based intervention that integrates real-time electroencephalogram (EEG) signals from a wearable headband into an immersive virtual reality (VR) environment. The intervention is designed to provide feedback related to neural activity patterns associated with cortical reactivity and to support developmentally appropriate self-regulation skills.

The trial uses a randomized, parallel-group design. Following a baseline/run-in phase that includes characterization of headache patterns and laboratory-based EEG assessment of cortical reactivity, participants are randomized to either:

Immersive Neurofeedback Self-Regulation Training (EEG-guided VR), or

A comparison immersive VR imagery condition without neurofeedback or guided relaxation training.

Both groups complete structured VR sessions at home according to a standardized schedule. Laboratory-based EEG assessment of cortical reactivity is repeated post-treatment to evaluate mechanistic signals related to neural modulation in pediatric migraine.

The primary objectives of this feasibility trial are to evaluate recruitment procedures, randomization processes, intervention adherence, retention, tolerability, and completeness of outcome data collection in adolescents with migraine. These data will inform refinement of study procedures and intervention parameters in preparation for a future fully powered pediatric efficacy trial.

Exploratory analyses will examine preliminary patterns of change in headache-related disability and related clinical outcomes to estimate effect sizes and variability for future trial planning.

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark A Connelly, PhD; Phone Number: 816-234-3193; Email: mconnelly1@cmh.edu

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Recruiting
      • Children's Mercy
      • Contact: Priscilla Connell, PhD; Phone Number: 816-816-6979; Email: pconnell@cmh.edu
      • Contact: Mark Connelly, PhD; Phone Number: 816-234-3193; Email: mconnelly1@cmh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immersive Neurofeedback Self-Regulation Training (INSeRT); Participants 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.	Behavioral: Immersive Neurofeedback Self-Regulation Training (INSeRT); 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.
Active Comparator: Virtual Reality Imagery (No Neurofeedback); Participants 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.	Behavioral: Virtual Reality Imagery (No Neurofeedback); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pediatric Migraine Disability Assessment (PedMIDAS) Score (30-day)	Migraine-related disability will be assessed using the Pediatric Migraine Disability Assessment (PedMIDAS). In this study, items assess number of days of disability during the past 30 days. The 30-day total score will be multiplied by 3 to generate a 90-day equivalent score for comparability with the original instrument. Total scores range from 0 to 240, with higher scores indicating greater migraine-related disability.	Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)
Change in Headache Frequency	Headache frequency will be measured using prospective electronic daily migraine diaries. A headache day is defined as any calendar day in which the participant reports a headache. The outcome will be the total number of headache days recorded during each 4-week monitoring period. Possible range: 0 to 28 days. Higher values indicate greater 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)	Anxiety symptoms will be assessed using the 8-item PROMIS Pediatric Anxiety short form. Items are rated on a 5-point scale (Never to Always). Raw scores will be converted to standardized PROMIS T-scores (mean = 50, SD = 10), with higher scores indicating greater anxiety symptoms.	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)	Depressive symptoms will be assessed using the 8-item PROMIS Pediatric Depression short form. Items are rated on a 5-point scale (Never to Always). Raw scores will be converted to standardized PROMIS T-scores (mean = 50, SD = 10), with higher scores indicating greater depressive symptoms.	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	Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10). Items are rated on a 5-point scale from 0 (Never) to 4 (Very Often). Four positively worded items will be reverse-scored, and item responses will be summed to generate a total score ranging from 0 to 40. Higher scores indicate greater perceived stress.	Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase).
Change in Pain Self-Efficacy Scale Total Score (7-Item Version)	Pain-related self-efficacy will be assessed using a 7-item Pain Self-Efficacy Scale. Items are rated on a 5-point scale from 1 (Very unsure) to 5 (Very sure). Item responses will be summed to generate a total score ranging from 7 to 35, with higher scores indicating greater confidence in functioning despite pain.	Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)
Change in Pain Catastrophizing Scale - Child (PCS-C) Total Score	Pain catastrophizing will be assessed using the 13-item Pain Catastrophizing Scale - Child version (PCS-C). Items are rated on a 5-point scale from 0 (Not at all) to 4 (Extremely). Item responses will be summed to generate a total score ranging from 0 to 52. Higher scores indicate greater pain catastrophizing.	Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Resting EEG State EEG Spectral Power	Mean cortical source power derived from resting-state electroencephalography (EEG), calculated across standard frequency bands (delta, theta, alpha, beta, and gamma) using source-localized analysis. Power values (µV²) will be averaged within predefined brain regions (frontal, occipital, and temporal areas). Change from baseline to post-treatment will be explored.	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	Movement-related spectral power (µV²) derived from EEG recordings during a finger-tapping task, calculated across standard frequency bands using source-localized analysis. Power values will be averaged across predefined cortical regions. Change from baseline to post-treatment will be examined.	Baseline to post-treatment EEG assessment window (approximately Day 72 + 21 days from baseline)
Changes in Finger-Tapping Reaction Time	Mean reaction time (milliseconds) during a finger-tapping task performed during EEG assessment. Change from baseline to post-treatment will be examined.	Baseline to post-treatment EEG assessment window (approximately Day 72 + 21 days from baseline)

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Mark A Connelly, PhD, Children's Mercy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Adolescents; Electroencephalogram; Cortical excitability; EEG; Biofeedback; Virtual reality; Neurofeedback; Self-regulation; Pediatric migraine; Mind-body therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Behavior; Social Behavior; Migraine Disorders; Headache Disorders, Primary; Self-Control; Investigative Techniques; Genetic Phenomena; Genetic Techniques; Genetic Variation; Protein Engineering; Genetic Engineering; Mutation; Mutagenesis; Mutagenesis, Insertional
• Other Study ID Numbers: STUDY00002995; 1R34AT013083-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No