Pupillometry to measure pain and sensory problems in people with NF1
A Study to Evaluate the Feasibility of a Physiologic Biomarker to Assess Pain and Other Sensory Problems Using Pupillometry in Participants With Neurofibromatosis Type 1 (NF1)
This study will test whether the AlgometRx Nociometer, a pupillometry device, can measure pain and other sensory problems in children and adults with NF1.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 1 Year to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Trial ID | NCT06507748 on ClinicalTrials.gov |
What this trial studies
Participants aged 1 year and older will undergo up to three in-person assessments that include questionnaires about health and pain and device-based pupillometry measurements. The AlgometRx Nociometer combines infrared video pupillometry with neuroselective stimulation to produce a Neuropathy Index intended to reflect nociceptive processing. Each visit lasts about 1 to 1.5 hours and may include use of leftover blood samples collected for other purposes. The device use was determined to be non-significant risk by the institutional review board, and the protocol is conducted at two clinical centers.
Who should consider this trial
Good fit: Ideal participants are individuals aged 1 year or older with a clinical or genetic diagnosis of NF1 who have at least one intact finger or toe, can understand English or Spanish (with caregiver language support for young children), and can attend in-person visits.
Not a fit: People with eye conditions that prevent pupillometry, without an accessible digit for device placement, or who cannot understand the required consent/language requirements are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, this device could provide a simple, non-invasive, objective biomarker to detect and monitor pain and sensory problems in people with NF1, helping guide clinical care.
How similar studies have performed: Pupillometry and related neuroselective stimulation approaches have precedent in pain research, but applying the AlgometRx Nociometer specifically in NF1 is relatively novel and not yet validated.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * History of clinical or genetic diagnosis of NF1 as per the 2021 revised diagnostic criteria * Age \>= 1 year * At least one digit (finger or toe) without open wounds for application of the device * Individuals must understand English or Spanish * Individuals who are \< 18 years must have a caregiver willing to help the child engage in study procedures, assist with fitting the AlgometRx Nociometer (Registered Trademark) device, and complete the observer reported (ObsRO) measures. Note: the caregiver of a child participant \>= 5 years old must be able to understand English or Spanish, the caregiver of a child participant 1-4 years old must be able to understand English (to help complete the observational pain measure for the younger children that is only available in English) * Ability of individual or parent/guardian to understand and the willingness to sign a written informed consent document EXCLUSION CRITERIA * History of eye pathology which precludes pupillometry, such as problems with pupillary reflex, blindness or inability to open at least one eye fully for evaluation * Individuals with chronic use of medication that specifically affects their pupillary response, such as atropine-containing eye drops * Uncontrolled intercurrent illness evaluated by medical history that would potentially increase in risk of participant
Where this trial is running
Washington D.C., District of Columbia and 1 other locations
- Children's National Medical Center — Washington D.C., District of Columbia, United States (Not_yet_recruiting)
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Pamela L Wolters, Ph.D. — National Cancer Institute (NCI)
- Study coordinator: Pamela L Wolters, Ph.D.
- Email: woltersp@mail.nih.gov
- Phone: (240) 760-6035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.