A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine

Browse trials for

• Migraine Disorders 1,657
• Headache Disorders, Primary 42
• Self-Control 168

Keywords

• Pediatric migraine
• Adolescents
• Neurofeedback
• Virtual reality
• Electroencephalogram
• EEG
• Cortical excitability
• Self-regulation
• Biofeedback
• Mind-body therapy

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

This study's planned enrollment of 38 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.

Lead sponsor

Children's Mercy Hospital Kansas City is the lead sponsor of 210 studies on the registry; 20 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.

Study arms

• 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)

• 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)

Interventions

• BehavioralImmersive 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.

• BehavioralVirtual 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.

Primary outcomes

1. 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.

   Time frame: From study initiation through completion of enrollment (approximately 24 months)

2. 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.

   Time frame: From enrollment through completion of pre-treatment preparation phase (approximately 6 weeks after enrollment)

3. 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.

   Time frame: Pre-treatment

4. 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.

   Time frame: During the 4-week intervention phase

5. 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.

   Time frame: During the 4-week intervention phase

6. 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.

   Time frame: Post-treatment survey window (Day 72 through Day 86 after baseline)

7. 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.

   Time frame: Post-treatment survey window (Day 72 through Day 86 after baseline)

8. Retention Through 3-Month Follow-Up

   Proportion of randomized participants who complete the 3-month follow-up questionnaires and diary collection period.

   Time frame: Up to approximately 162 days after baseline/enrollment

Secondary outcomes

1. 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.

   Time frame: Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)

2. 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.

   Time frame: 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).

3. 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.

   Time frame: Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)

4. 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.

   Time frame: Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)

5. 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.

   Time frame: Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase).

6. 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.

   Time frame: Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)

7. 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.

   Time frame: Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)

Other outcomes

1. 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.

   Time frame: Baseline to post-treatment EEG assessment window (approximately Day 72 + 21 days from baseline)

2. 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.

   Time frame: Baseline to post-treatment EEG assessment window (approximately Day 72 + 21 days from baseline)

3. 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.

   Time frame: Baseline to post-treatment EEG assessment window (approximately Day 72 + 21 days from baseline)

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. PubMed 36832458 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.