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NCT06507748Recruiting

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)

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

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....

Status (registry)
Recruiting
Study type
Interventional
Enrollment
70 (estimated)
First submitted
17 Jul 2024
Start date
18 Feb 2026
Primary completion date
1 May 2027
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT06507748

What you commit to

  • Study type: Interventional
  • Planned participants: 70
  • From 18 Feb 2026 to the primary completion date, 1 May 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Individuals with chronic use of medication that specifically affects their pupillary response, such as atropine-containing eye drops

Other illness

  • 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
  • Uncontrolled intercurrent illness evaluated by medical history that would potentially increase the risk to the participant

Criteria the registry did not label

  • 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

Age in the registry: 1 year to 120 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National Institutes of Health Clinical Center
Coordinator of this site? Confirm its status
BethesdaUnited StatesRecruiting
Children's National Medical Center
Coordinator of this site? Confirm its status
Washington D.C.United StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.