Recruiting

INSeRT vs. VR Program

Sponsor:

Children's Mercy Hospital Kansas City

Code:

NCT07454798

Conditions

Migraine

Headache Disorders, Primary

Eligibility Criteria

Sex: All

Age: 10 - 16

Healthy Volunteers: Not accepted

Interventions

Immersive Neurofeedback Self-Regulation Training (INSeRT)

Virtual Reality Imagery (No Neurofeedback)

Study Details

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

Conditions

Migraine

Headache Disorders, Primary

Study ID

NCT07454798

Start date

May 13, 2026

Status verified date

Jun, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 16

Healthy Volunteers: Not accepted

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 Design

Enrollment

38 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Feasibility of Recruitment and Enrollment [ Time Frame: From study initiation through completion of enrollment (approximately 24 months) ]
  • Feasibility of Randomization and Treatment Initiation [ Time Frame: From enrollment through completion of pre-treatment preparation phase (approximately 6 weeks after enrollment) ]
  • Treatment Credibility (Child-Adapted Credibility/Expectancy Questionnaire - Credibility Subscale) [ Time Frame: Pre-treatment ]
  • Percent of Prescribed Virtual Reality Sessions Completed [ Time Frame: During the 4-week intervention phase ]
  • Mean Duration of Virtual Reality Sessions [ Time Frame: During the 4-week intervention phase ]
  • Cybersickness Symptoms Questionnaire (CSQ-VR) Mean Total Score [ Time Frame: Post-treatment survey window (Day 72 through Day 86 after baseline) ]
  • Child-Adapted System Usability Scale (SUS) Total Score [ Time Frame: Post-treatment survey window (Day 72 through Day 86 after baseline) ]
  • Retention Through 3-Month Follow-Up [ Time Frame: Up to approximately 162 days after baseline/enrollment ]

Central Contacts and Locations

Central contacts

Mark A Connelly, PhD

816-234-3193mconnelly1@cmh.edu

Locations

Children's Mercy

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Priscilla Connell, PhD

816-816-6979pconnell@cmh.edu

Mark Connelly, PhD

816-234-3193mconnelly1@cmh.edu

More Information

Sponsor

Children's Mercy Hospital Kansas City

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Mercy Hospital Kansas City on 2026-06-03.