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Feasibility of Home-based Immersive Neurofeedback Self-regulation Training (INSeRT) for Youth With Migraine

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
United States
Missouri
Children's Mercy
RECRUITING
Kansas City
Contact Information
Primary
Mark A Connelly, PhD
mconnelly1@cmh.edu
816-234-3193
Time Frame
Start Date: 2026-05-13
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 38
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Leads: Children's Mercy Hospital Kansas City

This content was sourced from clinicaltrials.gov