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AlgometRx Nociometer for Neurofibromatosis

N/A
Waitlist Available
Led By Pamela L Wolters, Ph.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of clinical or genetic diagnosis of NF1 as per the 2021 revised diagnostic criteria
At least one digit (finger or toe) without open wounds for application of the device
Must not have
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
Participants with chronic use of medication that specifically affects their pupillary response, such as atropine-containing eye drops
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time 1, repeated 1-72 hours later (time 2)
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study a device called the AlgometRx Nociometer to measure pain and abnormal sensations in people with Neurofibromatosis type 1 (NF1). Participants with NF1

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial uses non-painful stimuli and observes physiological responses, significant side effects are not anticipated. However, discomfort from the electrode placement on fingers or toes might occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with NF1 according to the latest criteria.
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I have at least one finger or toe without open wounds.
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I understand either English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot have my pupil reflex tested due to an eye condition.
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I use medication that affects my pupil response, like atropine eye drops.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time 1, repeated 1-72 hours later (time 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time 1, repeated 1-72 hours later (time 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Describe the teasibility of using AlgometRx Nociometer device in different age groups
Secondary study objectives
Describe the acceptability of the physiologic pain assessment using the AlgometRx Nociometer device in different age groups
Evaluate safety of physiologic pain assessment
Evaluate the construct validity of the physiologic pain measure (Neuropathy Index)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1/Feasibility and longitudinal assessmentsExperimental Treatment1 Intervention
Evaluation with the AlgometRx device and patient- and observer-reported outcome measures

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,925 Previous Clinical Trials
41,017,931 Total Patients Enrolled
3 Trials studying Neurofibromatosis
290 Patients Enrolled for Neurofibromatosis
Pamela L Wolters, Ph.D.Principal InvestigatorNational Cancer Institute (NCI)
4 Previous Clinical Trials
1,180 Total Patients Enrolled
~47 spots leftby May 2026
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