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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Describe the feasibility of using AlgometRx Nociometer device in different age groups
研究概览
简要总结
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....
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •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
排除标准
- •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
研究组 & 干预措施
1/Feasibility and longitudinal assessments
Evaluation with the AlgometRx device and patient- and observer-reported outcome measures
干预措施: AlgometRx Nociometer (Device)
结局指标
主要结局
Describe the feasibility of using AlgometRx Nociometer device in different age groups
时间窗: 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.
次要结局
- Evaluate the construct validity of the physiologic pain measure (Neuropathy Index)(Time 1)
- Evaluate safety of physiologic pain assessment(Time 1, Time 2, Time 3)
- Describe the acceptability of the physiologic pain assessment using the AlgometRx Nociometer device in different age groups(Time 1)
- Evaluate the test-retest reliability of the physiologic pain measure (Neuropathy Index)(Time 1, repeated 1-72 hours later (Time 2))
- Evaluate the physiologic pain measure (Neuropathy Index) on sensitivity to change in pain(Time 1, repeated 4 weeks to 18 months later (Time 3))