NCT07454798Recruiting
A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine
Feasibility of Home-based Immersive Neurofeedback Self-regulation Training (INSeRT) for Youth With Migraine
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 18 Feb 2026
- Start date
- 13 May 2026
- Primary completion date
- 31 May 2028
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Diseases
- Migraine
- NCT number
- NCT07454798
What you commit to
- Study type: Interventional
- Planned participants: 38
- From 13 May 2026 to the primary completion date, 31 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Significant physical, psychiatric, or developmental conditions that would limit ability to participate in study procedures
- History of epilepsy or photosensitive seizures
Who the study is looking for
- 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
Age in the registry: 10 years to 16 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Mercy Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.