Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507748
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief 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
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09-27
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 is effective in measuring pain or other abnormal sensations in people with NF1
Eligibility
People aged 1 year and older with NF1
Design
Participants can have up to 3 assessments completed in person Each assessment may last up to 10 to 15 hours
Participants 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
Participants 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
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 is effective in measuring pain or other abnormal sensations in people with NF1
Eligibility
People aged 1 year and older with NF1
Design
Participants can have up to 3 assessments completed in person Each assessment may last up to 10 to 15 hours
Participants 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
Participants 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 eg plexiform neurofibromas PN and non-tumor eg 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 reflexeshyperreflexia 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 Childrens 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 plusminus 3 and total enrollment of 70 participants
Chronic pain is a common and often debilitating symptom of neurofibromatosis 1 NF1 that is related to multiple tumor eg plexiform neurofibromas PN and non-tumor eg 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 reflexeshyperreflexia 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 Childrens 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 plusminus 3 and total enrollment of 70 participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None