Actively Recruiting

Phase Not Applicable
Age: 1Year - 120Years
All Genders
NCT06507748

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 2026-05-14

70

Participants Needed

2

Research Sites

62 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: Neurofibromatosis type 1 (NF1) is a genetic condition that causes tumors to grow along the nerves in the skin, brain, and other parts of the body. People with NF1 often have pain and may experience other abnormal sensations like itching, numbness, or tingling. These symptoms can affect their daily life. Researchers want to learn more about these symptoms and find better ways to measure pain in people with NF1. Objective: To learn if a device called the AlgometRx Nociometer(Registered trademark) is effective in measuring pain or other abnormal sensations in people with NF1. Eligibility: People aged 1 year and older with NF1. Design: Individuals can have up to 3 assessments completed in person. Each assessment may last up to 1.0 to 1.5 hours. Individuals will be screened. They will complete questionnaires about their health and how bad their pain is. If participants are having blood drawn for other reasons, some additional samples may be used in this study. The AlgometRx Nociometer includes an electrode that will be placed onto a finger or a toe. The electrode will send non-painful electrical signals to activate nerves in the finger or toe. At the same time, a camera will be used to record changes in the pupil of the eye. The test will be done on all 4 of the participant s limbs; however, researchers may skip 1 or more limbs for various reasons. This test takes about 10 seconds to complete with at least a one-minute rest between testing different limbs. Individuals will be asked to do a 2nd assessment with the AlgometRx Nociometer that may be done 1 hour later but no more than 72 hours after the first assessment. Participants who will be returning for another visit can opt to do a 3rd assessment that will be done at least 4 weeks but not more than 18 months after the 1st....

CONDITIONS

Official 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

Age: 1Year - 120Years
All Genders

Eligibility Criteria

Eligible

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
  • For participants under 18, a caregiver willing to assist with study procedures and device use
  • Willingness and ability to sign informed consent
Not Eligible

You will not qualify if you...

  • Eye conditions preventing pupillometry, such as impaired pupillary reflex, blindness, or inability to open one eye fully
  • Chronic use of medications that affect pupil response, like atropine-containing eye drops
  • Uncontrolled illnesses that increase participant risk as determined by medical history

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

Research Team

P

Pamela L Wolters, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here