Clinical trial NCT06994988: ARPA-H Smart Band-Aid to Measure Chronic Pain in Women
Official title: Multi-modal Smart Band-Aid for AI-based Quantification of Pain
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Pain
Keywords: Smart Band-Aid
A-Band
Chronic Pain
ARPA-H
AI and Chronic Pain
Objective measure
Biomarker
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Tufts University
name: The Advanced Research Projects Agency for Health (ARPA-H)
name: Walter Reed National Military Medical Center
name: Uniformed Services University of the Health Sciences
name: Henry M. Jackson Foundation for the Advancement of Military Medicine
First posted: 2025-05-29
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Biological females with chronic pain and biological females without chronic pain

Brief summary: 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

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Difference between patient-reported pain score and objective pain score as calculated by AI
timeFrame: Days 0 thru 7, for 8 total days
Secondary outcomes:
measure: Pain Scores from Biochemical and Biophysical Measurements & Instruments Measured from Questionnaires (affective-motivational and cognitive components)
timeFrame: From Day 0 thru Day 7, for 8 total days
measure: Patient-reported pain score
timeFrame: Days 0 thru 7, for 8 total days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
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