Evaluating a New Device to Measure Pain and Sensory Issues Using Pupillometry in People with Neurofibromatosis Type 1 NF1

What this Trial Is About

Neurofibromatosis type 1 NF1 is a genetic condition causing tumors along nerves that can lead to pain and other abnormal sensations like itching, numbness, or tingling. These symptoms affect daily life, and measuring pain in NF1 patients, especially children and those with learning disabilities, can be challenging. Researchers aim to evaluate a device called the AlgometRx Nociometer to see if it can effectively measure pain and sensory problems in people with NF1. The study uses the AlgometRx Nociometer, a device combining infrared pupillometry and nerve stimulation, to assess pain objectively through a Neuropathy Index. Participants will have assessments with the device that involves placing an electrode on a finger or toe to send gentle electrical signals while a camera records pupil changes. Testing covers up to three sessions per participant over intervals ranging from one hour to up to 18 months. The study involves participants of all ages starting from 1 year old, grouped by age cohorts. Participants will complete health and pain questionnaires and may provide blood samples if already drawn for other reasons. The device testing takes about 10 seconds per limb, with rest periods between limbs. Researchers will evaluate the devices feasibility, acceptability, reliability, validity, sensitivity to change, and safety. The study is designed to help improve pain measurement methods in NF1 and may inform future clinical trials. Participation includes up to three assessments lasting 1 to 1.5 hours each.

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)