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Study of AlgometRx Nociometer for Pain Measurement in NF1

This study is looking into a new way to measure pain and other unusual sensations in people with Neurofibromatosis Type 1 (NF1). NF1 is a genetic condition that can cause tumors and often leads to pain, itching, or numbness. Researchers want to see if a device called the AlgometRx Nociometer can effectively measure these sensations. This device uses pupillometry (measuring changes in your pupil) to assess pain. The main goal is to see how practical and useful this device is for different age groups. You can join if you are at least 1 year old and have a diagnosis of NF1. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 70 participants with Neurofibromatosis Type 1. It is not specified if it is randomized or blinded.
What's involved
You would have up to three in-person assessments, each lasting 1 to 1.5 hours. A caregiver must assist children under 18 with study procedures.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, feasibility of the device, is measured at Baseline (enrollment, Time 1).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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)

Recruiting
NAAges 1+InterventionalDevice feasibility
National Cancer Institute (NCI)
~70 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:AlgometRx Nociometer

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Describe the feasibility of using AlgometRx Nociometer device in different age groups
Measured over Baseline (enrollment, Time 1)

Conditions

Neurofibromatosis Type 1

Explore related trials

Neurofibromatosis Type 1

Where it's being run

2 sites across 2 states
District of Columbia1
Maryland1

Study leadership

  • Pamela L Wolters, Ph.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Pamela L Wolters, Ph.D.
[email protected]
(240) 760-6035
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 the risk to the participant

What this trial measures

  • Describe the feasibility of using AlgometRx Nociometer device in different age groupsBaseline (enrollment, Time 1)

    Proportion of individuals who successfully complete the AlgometRx Nociometer assessment by each of the five age stratified groups (1-4, 5-7, 8-12, 13-17, 18+ years). This analysis will be performed on the Feasibility Analysis Data Set. Successful completion rate for each age group.