An interventional study of AlgometRx Nociometer(R) in Neurofibromatosis Type 1, sponsored by National Cancer Institute (NCI). Recruiting at 2 sites in United States. Open to participants aged 1 Year to 120 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by National Cancer Institute (NCI) · Not applicable, Interventional, and Device feasibility
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....
Background:
Objective:
-To describe the feasibility of using the AlgometRx Nociometer (Registered Trademark) device to conduct a physiologic assessment of pain in different age groups of participants with NF1.
Eligibility:
Design:
176 studies on the registry are indexed under Neurofibromatosis 1; 43 are open to participants now.
This study's planned enrollment of 70 is above the median of 35 across 114 interventional studies indexed under Neurofibromatosis 1.
Browse Neurofibromatosis 1 studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION CRITERIA
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Evaluation with the AlgometRx device and patient- and observer-reported outcome measures
Device: AlgometRx Nociometer(R)
Novel objective pain measurement device
Describe the feasibility of using AlgometRx Nociometer(R) 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.
Time frame: Baseline (enrollment, Time 1)
Describe the acceptability of the physiologic pain assessment using the AlgometRx Nociometer(R) device in different age groups
Acceptability will be described per age group for the three questions on the Acceptability Questionnaire.
Time frame: Time 1
Evaluate the test-retest reliability of the physiologic pain measure (Neuropathy Index)
Test-retest reliability will be measured by the intraclass correlation coefficient in participants with stable pain.
Time frame: Time 1, repeated 1-72 hours later (Time 2)
Evaluate the construct validity of the physiologic pain measure (Neuropathy Index)
Convergent and discriminant validity with the PRO/ObsRO measures will be measured through parametric (Pearson s) or nonparametric (Spearman s) tests, depending on the normality and distribution of the data.
Time frame: Time 1
Evaluate the physiologic pain measure (Neuropathy Index) on sensitivity to change in pain
Sensitivity to change will be measured through paired t-tests or Wilcoxon signed-rank test, depending on the normality and distribution of the data, to evaluate the statistical significance of the change in scores. We also may use standardized response means, which is a type of effect size, and one of the best methods to estimate responsiveness of measures.
Time frame: Time 1, repeated 4 weeks to 18 months later (Time 3)
Evaluate safety of physiologic pain assessment
Evaluated by collection and assessment of ADEs (adverse device effects).
Time frame: Time 1, Time 2, Time 3
Plan to share: Yes — This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Cancer Institute (NCI) →