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)

NCT06507748 | Recruiting

• 2 other identifiers: 10001826001826-C
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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

Neurofibromatosis Type 1

Keywords

Neurofibromatosis Type 1; Plexiform Neurofibromas; Pain; Sensation; Clinical outcomes; Objective measurement; Biomarker

Outcome Measures

Primary Outcomes (1)

• Describe the feasibility of using AlgometRx Nociometer device in different age groups

  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.

  Baseline (enrollment, Time 1)

Secondary Outcomes (5)

• Describe the acceptability of the physiologic pain assessment using the AlgometRx Nociometer device in different age groups

  Time 1

• Evaluate the test-retest reliability of the physiologic pain measure (Neuropathy Index)

  Time 1, repeated 1-72 hours later (Time 2)

• Evaluate the construct validity of the physiologic pain measure (Neuropathy Index)

  Time 1

• Evaluate the physiologic pain measure (Neuropathy Index) on sensitivity to change in pain

  Time 1, repeated 4 weeks to 18 months later (Time 3)

• Evaluate safety of physiologic pain assessment

  Time 1, Time 2, Time 3

Study Arms (1)

1/Feasibility and longitudinal assessments

OTHER

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

Device: AlgometRx Nociometer

Interventions

AlgometRx Nociometer DEVICE

Novel objective pain measurement device

1/Feasibility and longitudinal assessments

Eligibility Criteria

• Age: 1 Year - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 in risk of participant

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Children's National Medical Center

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

NOT YET RECRUITING

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neurofibromatosis 1; Neurofibroma, Plexiform; Pain

Condition Hierarchy (Ancestors)

Neurofibromatoses; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pamela L Wolters, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela L Wolters, Ph.D.

CONTACT

(240) 760-6035; woltersp@mail.nih.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 18, 2024
• Study Start: February 18, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (2)