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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the AlgometRx Nociometer can effectively measure pain and other unusual sensations in individuals with neurofibromatosis type 1 (NF1), a genetic condition that often causes pain and tumors along nerves. The study investigates whether this device can offer better insights into the pain experienced by those with NF1. Individuals with NF1, no open wounds on their fingers or toes, and who understand English or Spanish might be suitable for this trial. Participants will have electrodes placed on a finger or toe to measure nerve response while their eye movements are recorded, with assessments conducted up to three times. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance pain management for NF1 patients.

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 prior data suggests that the AlgometRx Nociometer is safe for measuring pain in people with NF1?

Research shows that the AlgometRx Nociometer measures pain without causing discomfort. It sends gentle electrical signals to a finger or toe, which are not painful. The process also involves observing changes in the eye's pupil, but this is purely visual and does not involve touching the eye.

Specific information about side effects from using the Nociometer is not available. However, since the study is in an early phase, the device is primarily being tested for safety and effectiveness. Generally, devices at this stage are considered quite safe, especially since the Nociometer is designed to avoid pain or harm. Prospective participants should find the device well-tolerated without significant risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AlgometRx Nociometer because it offers a novel way to objectively measure pain levels in patients with neurofibromatosis. Unlike traditional methods that rely on subjective patient reporting, this device uses advanced technology to provide a quantifiable assessment of pain. This could lead to more accurate diagnoses and personalized treatment plans, improving patient care and outcomes. By providing a clearer picture of a patient's pain experience, the AlgometRx Nociometer may revolutionize how pain is managed in neurofibromatosis.

What evidence suggests that the AlgometRx Nociometer is effective for measuring pain in people with NF1?

Research is exploring whether the AlgometRx Nociometer, used to evaluate participants in this trial, can accurately measure pain and other unusual sensations in people with Neurofibromatosis type 1 (NF1). This device uses a small sensor placed on a finger or toe to send signals to the nerves, while a camera observes changes in the eye's pupil. These signals do not cause pain but are designed to create a measurable nerve response. The aim is to find a reliable way to measure pain in NF1 patients, who often experience discomfort that affects their daily lives. Early results suggest this method could aid in understanding and managing pain for those with NF1. ^{1 2 6 7 8}

Who Is on the Research Team?

Pamela L Wolters, Ph.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

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

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

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

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06507748

NCT06507748 | A Study to Evaluate the Feasibility of ... To learn if a device called the AlgometRx Nociometer(Registered trademark) is effective in measuring pain or other abnormal sensations in people with NF1.

2. clinicalstudies.info.nih.gov clinicalstudies.info.nih.gov/protocoldetails.aspx?id=001826-C&&query=

NIH Clinical Center: Search the Studies To learn if a device called the AlgometRx Nociometer(Registered trademark) is effective in measuring pain or other abnormal sensations in people with NF1.

3. synapse.org synapse.org/Synapse:syn61777297

Evaluation of a Novel Physiologic Biomarker of Pain in ... The purpose of this study is to look at the use of the AlgometRx device in patients with NF1 as a measurement of pain. We want to find out if all patients with ...

4. clinconnect.io clinconnect.io/trials/NCT06507748

A Study to Evaluate the Feasibility of a Physiologic - ClinConnect This clinical trial is studying a new way to measure pain and other unusual sensations in people with Neurofibromatosis Type 1 (NF1), a genetic condition that ...

5. ctf.org ctf.org/news/2024-clinical-research-award-collaboration/

2024 Clinical Research Award Collaboration This collaborative grant will support research into a new tool developed at Children's National Hospital called the AlgometRx Nociometer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12044096/

Development of patient reported outcome measures ... Using qualitative data from patients and expert input, two PRO measures were developed that assess pNF-related pain intensity and pain ...

7. ctf.org ctf.org/news/ctf-clinical-research-awards/

CTF Clinical Research Awards The present study will identify biomarkers in the plasma of NF1 patients with plexiform neurofibromas that change in concentration as a result ...

8. ispor.org ispor.org/docs/default-source/euro2024/isporeurope24adeyemimsr8poster144359-pdf.pdf?sfvrsn=d1c8c24d_0

Psychometric Validation of the PAINS-pNF Target ... The analyses were conducted using two independent datasets from KOMET: the first set was from a data cut-off (DCO) of November.