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New Pain-Measuring device could help people with NF1

NCT ID NCT06507748

Knowledge-focused Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a device called the AlgometRx Nociometer to see if it can measure pain and other abnormal sensations in people with neurofibromatosis type 1 (NF1). The device uses a small electrode on a finger or toe to send painless signals and a camera to record changes in the pupil of the eye. Researchers hope this will provide a better way to assess pain, especially in those who have trouble describing it. The study involves up to 70 participants aged 1 year and older.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AlgometRx Nociometer device
What this could lead to
If successful, this could provide a new, objective way to measure pain in people with NF1, helping doctors better understand and manage their symptoms.
What could go wrong
This is an early feasibility study with only 70 participants, so results may not apply to everyone. The device is still experimental and may not work as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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 EXCLUSION CRITERIA * 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

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Conditions

The condition(s) this trial relates to.

neurofibromatosis type 1 Pain plexiform neurofibroma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neurofibromatosis type 1

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's National Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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