AlgometRx Nociometer for Neurofibromatosis

Overseen By Pamela L Wolters, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: National Cancer Institute (NCI)

Must not be taking: Atropine eye drops

Disqualifiers: Eye pathology, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

70 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use medications that affect your eye's pupil response, like certain eye drops.

What is the purpose of this trial?

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....

Research Team

Pamela L Wolters, Ph.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

This trial is for individuals aged 1 year and older who have Neurofibromatosis type 1 (NF1). They will undergo assessments that may last up to 1.5 hours, involving non-painful electrical signals sent to their limbs while changes in their eye's pupil are recorded.

Inclusion Criteria

Ability of participant or parent/guardian to understand and the willingness to sign a written informed consent document

I have been diagnosed with NF1 according to the latest criteria.

I have at least one finger or toe without open wounds.

Exclusion Criteria

I cannot have my pupil reflex tested due to an eye condition.

I use medication that affects my pupil response, like atropine eye drops.

Uncontrolled intercurrent illness evaluated by medical history that would potentially increase in risk of participant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Initial Assessment

Participants undergo the first assessment with the AlgometRx Nociometer, including questionnaires and potential blood sample collection

1 day

1 visit (in-person)

Follow-up Assessment

Participants complete a second assessment with the AlgometRx Nociometer 1-72 hours after the initial assessment

1-3 days

1 visit (in-person)

Long-term Follow-up

Participants may opt for a third assessment with the AlgometRx Nociometer 4 weeks to 18 months after the initial assessment

4 weeks to 18 months

1 visit (in-person)

Treatment Details

Interventions

• AlgometRx Nociometer

Trial Overview The study tests the AlgometRx Nociometer's effectiveness in measuring pain or other abnormal sensations like itching or numbness in NF1 patients. It involves a device sending signals to nerves and recording pupil reactions.

Participant Groups

Group I: 1/Feasibility and longitudinal assessments Experimental Treatment 1 Intervention

Evaluation with the AlgometRx device and patient- and observer-reported outcome measures

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+