ARPA-H Smart Band-Aid to Measure Chronic Pain in Women

Официальное название

Multi-modal Smart Band-Aid for AI-based Quantification of Pain

Обзор

The goal of this clinical trial is to test whether a minimally invasive microneedle patch, called the A-Band (Smart Band-aid), worn on the arm (monitoring key biomarkers in interstitial fluid) and a commercial smartwatch can accurately correlate with self-reported pain in women with chronic pain. A secondary purpose of the study is to identify demographic and clinical variables impacting pain measurement. The main questions that this study aims to answer are: * What is the correlation between AI-adjusted pain scores, based on biomarkers and validated tools, and self-reported pain scores? * What influence do demographic and clinical information have in the correlation of these pain scores? Researchers will compare data from these tools with self-reported pain scores in women with chronic pain and healthy women. Participants will: * Be a part of the study for approximately 8 days * Attend 2-3 in-person visits at the applicable clinical center over approximately one week * Wear a Smart Band-Aid (A-Band) at least twice per day for a week, with each application lasting up to 90 minutes * Complete questionnaires regarding medical history, pain information, mental health, sleep, and demographic data * Record daily pain scores * Wear a smartwatch for one week which will collect biophysical data (heart rate, skin response, etc.) * Collect daily saliva samples * Have blood drawn by medical staff at 2 in-person visits

Подробное описание

This study proposes the collection of interstitial fluid (ISF) from participants using a microneedle patch. ISF is a natural fluid found between your cells that can inform us on your bodily readings and health. A microneedle patch is a safe alternative to standard fluid collection which uses tiny needles to collect the ISF. The patches consist of single-use, sterile (clean) microneedles created from biocompatible materials. These microneedles penetrate the outermost skin layer without causing significant discomfort, pain, or bleeding.

The A-Band is an investigational device and has not been approved for use by the Food and Drug Administration (FDA).

Вмешательства

• Устройство A-Band (Smart Band-Aid)
  The A-Band is a smart band-aid placed on the forearm or other designated site that collects interstitial fluid (ISF) from participants using a microneedle patch. ISF is a natural fluid found between your cells that can inform us on your bodily readings and health. A microneedle patch is a safe alternative to standard fluid collection which uses tiny needles to collect the ISF. The patches consist of single-use, sterile (clean) microneedles created from biocompatible materials. These microneedles
• Комбинированный продукт Empatica Smartwatch
  A commercial smart band will be worn by participants for 22+ hours a day for approximately 7 days. The smart band collects biophysical data from the participant. This includes data on biomarkers, heart rate and heart rate variability, galvanic skin response, step count, and temperature fluctuations, among other biophysical data.
• Поведенческое Questionnaires: Hospital Anxiety & Depression Scale, Central Sensitization Inventory, Pain Catastrophizing Scale, Somatic Symptom Scale-8, Pain Self-Efficacy Questionnaire-10, Athens Insomnia Scale
  HADS- measures anxiety and depression (0-21, higher scores signify greater pathology); CSI- measures central sensitization (0-100, higher scores signify greater central sensitization, PCS- measures catastrophizing (0-52, higher scores signify greater catastrophization), SSS-8- measures somatization (0-32, higher scores signify greater somatization), PSEQ-10- measures self-efficacy (0-60, with lower scores signifying low self-efficacy), AIS- measures sleep (0-28, with higher scores signifying gre

Первичные конечные точки

• Difference between patient-reported pain score and objective pain score as calculated by AI [Срок оценки: Days 0 thru 7, for 8 total days]

Вторичные конечные точки (2)

• Pain Scores from Biochemical and Biophysical Measurements & Instruments Measured from Questionnaires (affective-motivational and cognitive components) [Срок оценки: From Day 0 thru Day 7, for 8 total days]
• Patient-reported pain score [Срок оценки: Days 0 thru 7, for 8 total days]

Критерии участия

Критерии включения

For chronic pain group:

• Female, 18 years or older.
• Diagnosis of chronic pain condition (e.g., fibromyalgia, chronic lower back pain) as determined by the Principal Investigator.
• Ability to provide informed consent.

For healthy controls:

• Female, 18 years or older.
• No history of chronic pain.
• No significant or poorly controlled medical conditions as determined by the Principal Investigator and exclusion criteria.
• No significant active, poorly controlled psychological conditions as determined by the Principal Investigator and exclusion criteria.
• Ability to provide informed consent.

Exclusion Criteria (both groups):

• Pregnant or breastfeeding women.

• Substance abuse or psychiatric disorders that interfere with study participation.
• Major medical conditions (such as severe cardiovascular, neurological, cancer or autoimmune diseases) or psychological conditions (e.g., active, poorly-controlled depression, anxiety disorder, PTSD, substance use disorder) that interfere with study participation.
• Possibility of secondary financial gain from participation
• Interventional pain treatment(s) within 6 weeks of baseline (injection, epidural, etc.)
• Current opioid usage or usage within 2 weeks of baseline

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 2 центра

• Northwestern University Feinberg School of Medicine — Chicago
• Walter Reed National Military Medical Center — Bethesda

Публикации

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• Eldabe S, Obara I, Panwar C, Caraway D. Biomarkers for Chronic Pain: Significance and Summary of Recent Advances. Pain Res Manag. 2022 Nov 7;2022:1940906. doi: 10.1155/2022/1940906. eCollection 2022. PMID 36385904
• Tracey I, Woolf CJ, Andrews NA. Composite Pain Biomarker Signatures for Objective Assessment and Effective Treatment. Neuron. 2019 Mar 6;101(5):783-800. doi: 10.1016/j.neuron.2019.02.019. PMID 30844399

Идентификаторы

NCT: NCT06994988 · STU00223452 · FP00008853

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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