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New treatment option for Neurofibromatosis Type 1
Official title 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)
ClinicalTrials.gov ID: NCT06507748
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 120
You may be able to join 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 \ = 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...
You likely can't join if
- History of eye pathology which precludes pupillometry, such as problems with pupillary reflex, blindness or inability to open at least one eye fully...
- 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
See the full eligibility 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 \ = 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...
- Ability of individual or parent/guardian to understand and the willingness to sign a written informed consent document
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.