Neurofibromatosis Type 1NCT06507748
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)
A study testing AlgometRx Nociometer(R) in people with Neurofibromatosis Type 1, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 120 years
- Conditions the study is for
- Neurofibromatosis Type 1
- What is being tested?
- AlgometRx Nociometer(R)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Feb 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
National Cancer Institute Referral Office, 888-624-1937, ncimo_referrals@mail.nih.gov
- Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Julia Finkel, M.D., 202-476-4867, jfinkel@cnmc.org
About this study
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.
Read more
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....
Read the detailed description
Background:
- Chronic pain is a common and often debilitating symptom of neurofibromatosis 1 (NF1) that is related to multiple tumor (e.g., plexiform neurofibromas; PN) and non-tumor (e.g., headaches) manifestations.
- Patient-reported outcome (PRO) measures have been used to assess pain in PN trials; however, few are validated for NF populations. In addition, the subjective measurement of pain symptoms can be difficult particularly in young children, those with learning disabilities, and due to patients having various types of NF-related pain and other sensory problems.
- There is a critical unmet need for a simple, non-invasive, and objective measure of pain and other sensory problems for individuals with NF1.
- AlgometRx Nociometer (Registered Trademark) is a novel integration of infrared video pupillometry and neuroselective stimulation, and the outcome measure obtained from an assessment with this device is the Neuropathy Index. The use of the AlgometRx Nociometer (Registered Trademark) in studies was determined to be non-significant risk (NSR) by the Children s National Hospital (CNH) Institutional Review Board (IRB) based on similar technologies that have been defined by the Food and Drug Administration (FDA) to be NSR.
- In addition to the early detection and targeted clinical management and monitoring of pain and nociceptive processing in patients with NF1, this device also may help us learn more about the underlying mechanisms of their pain, as well as their symptoms of numbness and tingling (paresthesia), muscle weakness, loss of reflexes/hyperreflexia, and altered sensation.
- This novel biomarker could fill a critical gap for an objective, simple, and sensitive assessment to quantify and monitor NF-related pain as a physiologic measure for clinical monitoring and as potential surrogate marker for response in treatment trials.
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:
- Participants must have a history of clinical or genetic diagnosis of NF1
- Age >= 1 year
- At least one eye with an intact pupillary reflex
- At least one digit (finger or toe) without open wounds for application of the device
- Must understand English or Spanish
- Participants 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).
Design:
- The design will be a multi-site diagnostic pilot study to describe the feasibility and acceptability and to evaluate the initial psychometric properties (reliability, validity, sensitivity to change) of a novel objective pain measurement device [AlgometRx Nociometer (Registered Trademark)] for use in future clinical trials for participants with NF1. NCI is the lead site and Children's National Hospital (CNH) is the participating site; both sites will enroll participants with NF1 in this study.
- A cross-sectional design will be used to describe the acceptability of the assessment with the AlgometRx Nociometer (Registered Trademark) device as well as construct validity of the Neuropathy Index. A longitudinal design will be used to assess test-retest reliability and sensitivity to change of the Neuropathy Index.
- The sample will consist of 55 evaluable participants who will be placed into 5 cohorts defined by age (1-4; 5-7; 8-12; 13-17; >= 18 years) with approximately 11 participants in each group (plus/minus 3) and total enrollment of 70 participants.
- Conditions
- Neurofibromatosis Type 1
- Being tested
- AlgometRx Nociometer(R)
- Keywords
- Neurofibromatosis Type 1, Plexiform Neurofibromas, Pain, Sensation, Clinical outcomes, Objective measurement, Biomarker
- Medical subject headings
- Neurofibromatosis 1, Neurofibroma, Plexiform, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlgometRx Nociometer(R)Device
Novel objective pain measurement device
| Study group | Role | What they receive |
|---|---|---|
| 1/Feasibility and longitudinal assessments | Other | Evaluation with the AlgometRx device and patient- and observer-reported outcome measures Receives: Device: AlgometRx Nociometer(R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (enrollment, Time 1)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Time 1, Time 2, Time 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start18 Feb 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurofibromatosis Type 1Studies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Pamela L Wolters, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507748
- Sponsor's protocol ID
- 10001826
- Other IDs
- 001826-C
- Status last verified
- 9 Oct 2026
- First submitted
- 17 Jul 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 10001826
- Conditions
- Neurofibromatosis Type 1
- Keywords
- Neurofibromatosis Type 1, Plexiform Neurofibromas, Pain, Sensation, Clinical outcomes, Objective measurement, Biomarker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
Detailed description
Background:
- Chronic pain is a common and often debilitating symptom of neurofibromatosis 1 (NF1) that is related to multiple tumor (e.g., plexiform neurofibromas; PN) and non-tumor (e.g., headaches) manifestations.
- Patient-reported outcome (PRO) measures have been used to assess pain in PN trials; however, few are validated for NF populations. In addition, the subjective measurement of pain symptoms can be difficult particularly in young children, those with learning disabilities, and due to patients having various types of NF-related pain and other sensory problems.
- There is a critical unmet need for a simple, non-invasive, and objective measure of pain and other sensory problems for individuals with NF1.
- AlgometRx Nociometer (Registered Trademark) is a novel integration of infrared video pupillometry and neuroselective stimulation, and the outcome measure obtained from an assessment with this device is the Neuropathy Index. The use of the AlgometRx Nociometer (Registered Trademark) in studies was determined to be non-significant risk (NSR) by the Children s National Hospital (CNH) Institutional Review Board (IRB) based on similar technologies that have been defined by the Food and Drug Administration (FDA) to be NSR.
- In addition to the early detection and targeted clinical management and monitoring of pain and nociceptive processing in patients with NF1, this device also may help us learn more about the underlying mechanisms of their pain, as well as their symptoms of numbness and tingling (paresthesia), muscle weakness, loss of reflexes/hyperreflexia, and altered sensation.
- This novel biomarker could fill a critical gap for an objective, simple, and sensitive assessment to quantify and monitor NF-related pain as a physiologic measure for clinical monitoring and as potential surrogate marker for response in treatment trials.
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:
- Participants must have a history of clinical or genetic diagnosis of NF1
- Age >= 1 year
- At least one eye with an intact pupillary reflex
- At least one digit (finger or toe) without open wounds for application of the device
- Must understand English or Spanish
- Participants 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).
Design:
- The design will be a multi-site diagnostic pilot study to describe the feasibility and acceptability and to evaluate the initial psychometric properties (reliability, validity, sensitivity to change) of a novel objective pain measurement device [AlgometRx Nociometer (Registered Trademark)] for use in future clinical trials for participants with NF1. NCI is the lead site and Children's National Hospital (CNH) is the participating site; both sites will enroll participants with NF1 in this study.
- A cross-sectional design will be used to describe the acceptability of the assessment with the AlgometRx Nociometer (Registered Trademark) device as well as construct validity of the Neuropathy Index. A longitudinal design will be used to assess test-retest reliability and sensitivity to change of the Neuropathy Index.
- The sample will consist of 55 evaluable participants who will be placed into 5 cohorts defined by age (1-4; 5-7; 8-12; 13-17; >= 18 years) with approximately 11 participants in each group (plus/minus 3) and total enrollment of 70 participants.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/Feasibility and longitudinal assessments | Other | Device: AlgometRx Nociometer(R)Evaluation with the AlgometRx device and patient- and observer-reported outcome measures |
Who may qualify
- Ages
- 1 year to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlgometRx Nociometer(R)Novel objective pain measurement device | Device | 1/Feasibility and longitudinal assessments |
Primary outcome
Describe the feasibility of using AlgometRx Nociometer(R) device in different age groups
Time frame: Baseline (enrollment, Time 1)
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.
5 secondary outcomes
Describe the acceptability of the physiologic pain assessment using the AlgometRx Nociometer(R) device in different age groups
Time frame: Time 1
Evaluate the test-retest reliability of the physiologic pain measure (Neuropathy Index)
Time frame: Time 1, repeated 1-72 hours later (Time 2)
Evaluate the construct validity of the physiologic pain measure (Neuropathy Index)
Time frame: Time 1
Evaluate the physiologic pain measure (Neuropathy Index) on sensitivity to change in pain
Time frame: Time 1, repeated 4 weeks to 18 months later (Time 3)
Evaluate safety of physiologic pain assessment
Time frame: Time 1, Time 2, Time 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pamela L Wolters, Ph.D. principal investigator
National Cancer Institute (NCI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AlgometRx Nociometer(R) in people with Neurofibromatosis Type 1, run by National Cancer Institute (NCI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela L Wolters, Ph.D. ((240) 760-6035, woltersp@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the feasibility of using AlgometRx Nociometer(R) device in different age groups (time frame: Baseline (enrollment, Time 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.