Actively Recruiting
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)
Led by National Cancer Institute (NCI) · Updated on 2026-06-05
70
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Neurofibromatosis type 1 (NF1) is a genetic disorder that causes tumors to grow along nerves in the skin, brain, and other areas. People with NF1 often experience pain and other abnormal sensations like itching, numbness, or tingling, which can interfere with daily activities. Researchers are studying the use of a device called the AlgometRx Nociometer to measure pain and sensory problems in people with NF1, aiming to find a simple and objective way to assess these symptoms across different age groups. The study involves using the AlgometRx Nociometer, a device that combines infrared video pupillometry with nerve stimulation via an electrode placed on a finger or toe. The device sends non-painful electrical signals to activate nerves while a camera records changes in the pupil. Participants may complete up to three assessments: the first and second assessments within 72 hours, and an optional third assessment between 4 weeks and 18 months later. Each assessment includes testing all four limbs, with rests between tests. Participants will attend in-person visits lasting 1 to 1.5 hours each. During these visits, they will complete health and pain questionnaires, and if undergoing blood draws for other reasons, extra samples may be collected for this study. Researchers will evaluate the feasibility, acceptability, reliability, and validity of the Neuropathy Index measured by the device, alongside safety monitoring. The total number of participants is planned to be around 70, grouped by age from 1 year and older.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of clinical or genetic diagnosis of NF1 as per the 2021 revised diagnostic criteria
- Age 1 year or older
- At least one finger or toe without open wounds for device application
- Ability to understand English or Spanish
- If under 18 years, caregiver willing to assist with study procedures and device fitting
- Caregiver of child participant 5 years or older must understand English or Spanish
- Caregiver of child participant 1-4 years must understand English
- Ability and willingness of participant or guardian to sign informed consent
You will not qualify if you...
- History of eye problems that prevent pupillometry, such as pupillary reflex issues, blindness, or inability to open one eye fully
- Chronic use of medications affecting pupil response, like atropine eye drops
- Uncontrolled illness that could increase risk to the participant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single assessment with additional follow-up assessments up to 18 months
Participants undergo evaluation using the AlgometRx Nociometer device and complete patient- and observer-reported outcome measures to assess pain and sensory problems.
1 baseline visit and 2 follow-up visits over 4 weeks to 18 months
Trial Site Locations
Total: 2 locations
1
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
2
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
P
Pamela L Wolters, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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