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)

Launched by NATIONAL CANCER INSTITUTE (NCI) · Jul 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to measure pain and other unusual sensations in people with Neurofibromatosis Type 1 (NF1), a genetic condition that can cause tumors to grow along nerves and lead to discomfort. Researchers want to see if a device called the AlgometRx Nociometer, which uses gentle electrical signals to stimulate nerves, can help assess these symptoms by observing changes in the pupil of the eye. The goal is to better understand how pain is experienced by those with NF1 and find improved methods for measuring it.

To participate in the study, individuals must be at least 1 year old and have a diagnosis of NF1. They will undergo up to three assessments over a period of time, where they will answer questions about their health and pain levels. During the assessments, electrodes will be placed on their fingers or toes to conduct the tests, which will take about 10 seconds for each limb. Participants will have the chance to return for additional assessments later on. It’s important to note that participants should not have any eye problems that affect their ability to respond to light or have certain medical conditions that could raise risks during the study.

Gender

ALL

Eligibility 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