MigraineINSeRTNCT07454798
A Feasibility Trial of Virtual Reality Neurofeedback for Adolescents With Migraine
A study testing Immersive Neurofeedback Self-Regulation Training (INSeRT) and Virtual Reality Imagery (No Neurofeedback) in people with Migraine and Headache Disorders, Primary, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Migraine, Headache Disorders, Primary
- What is being tested?
- Immersive Neurofeedback Self-Regulation Training (INSeRT) and Virtual Reality Imagery (No Neurofeedback)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Mercy
Kansas City, Missouri, 64108
Priscilla Connell, PhD, 816-816-6979, pconnell@cmh.edu
Mark Connelly, PhD, 816-234-3193, mconnelly1@cmh.edu
About this study
Official title: 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:
Read more
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
Read the 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.
- Conditions
- Migraine, Headache Disorders, Primary
- Being tested
- Immersive Neurofeedback Self-Regulation Training (INSeRT), Virtual Reality Imagery (No Neurofeedback)
- Keywords
- Pediatric migraine, Adolescents, Neurofeedback, Virtual reality, Electroencephalogram, EEG, Cortical excitability, Self-regulation, Biofeedback, Mind-body therapy
- Medical subject headings
- Migraine Disorders, Headache Disorders, Primary, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Neurofeedback Self-Regulation Training (INSeRT)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immersive Neurofeedback Self-Regulation Training (INSeRT) | Experimental | 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. Receives: Behavioral: Immersive Neurofeedback Self-Regulation Training (INSeRT) |
| Virtual Reality Imagery (No Neurofeedback) | Active comparator | 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. Receives: Behavioral: Virtual Reality Imagery (No Neurofeedback) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 162 days after baseline/enrollment
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start13 May 2026
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Mark Connelly, Children's Mercy Hospital Kansas City
- Investigators
- Mark A Connelly, PhD, Principal investigator, Children's Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454798
- Sponsor's protocol ID
- STUDY00002995
- Other IDs
- 1R34AT013083-01A1
- Acronym
- INSeRT
- Status last verified
- Jun 2026
- First submitted
- 18 Feb 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Home-based Immersive Neurofeedback Self-regulation Training (INSeRT) for Youth With Migraine
- ClinicalTrials.gov ID
- NCT07454798
- Acronym / sponsor ID
- INSeRT / STUDY00002995
- Conditions
- Migraine, Headache Disorders, Primary
- Keywords
- Pediatric migraine, Adolescents, Neurofeedback, Virtual reality, Electroencephalogram, EEG, Cortical excitability, Self-regulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 13 May 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immersive Neurofeedback Self-Regulation Training (INSeRT) | Experimental | Behavioral: 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. |
| Virtual Reality Imagery (No Neurofeedback) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Immersive Neurofeedback Self-Regulation Training (INSeRT) |
| 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. | Behavioural | Virtual Reality Imagery (No Neurofeedback) |
Primary outcome
Feasibility of Recruitment and Enrollment
Time frame: From study initiation through completion of enrollment (approximately 24 months)
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.
Feasibility of Randomization and Treatment Initiation
Time frame: From enrollment through completion of pre-treatment preparation phase (approximately 6 weeks after enrollment)
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.
Treatment Credibility (Child-Adapted Credibility/Expectancy Questionnaire - Credibility Subscale)
Time frame: Pre-treatment
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.
Percent of Prescribed Virtual Reality Sessions Completed
Time frame: During the 4-week intervention phase
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.
Mean Duration of Virtual Reality Sessions
Time frame: During the 4-week intervention phase
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.
Cybersickness Symptoms Questionnaire (CSQ-VR) Mean Total Score
Time frame: Post-treatment survey window (Day 72 through Day 86 after baseline)
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.
Child-Adapted System Usability Scale (SUS) Total Score
Time frame: Post-treatment survey window (Day 72 through Day 86 after baseline)
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.
Retention Through 3-Month Follow-Up
Time frame: Up to approximately 162 days after baseline/enrollment
Proportion of randomized participants who complete the 3-month follow-up questionnaires and diary collection period.
7 secondary outcomes
Change in Pediatric Migraine Disability Assessment (PedMIDAS) Score (30-day)
Time frame: Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)
Change in 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).
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety T-Score (8-Item Short Form)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Baseline through 3-month follow-up (approximately 90 days after completion of the 4-week treatment phase)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 36832458Connelly 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark A Connelly, PhD principal investigator
Children's Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Neurofeedback Self-Regulation Training (INSeRT) and Virtual Reality Imagery (No Neurofeedback) in people with Migraine and Headache Disorders, Primary, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark A Connelly, PhD (816-234-3193, mconnelly1@cmh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Recruitment and Enrollment (time frame: From study initiation through completion of enrollment (approximately 24 months)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07454798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.