Status:
NOT_YET_RECRUITING
ARPA-H Smart Band-Aid to Measure Chronic Pain in Women
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Tufts University
The Advanced Research Projects Agency for Health (ARPA-H)
Conditions:
Chronic Pain
Eligibility:
FEMALE
18+ years
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 c...
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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 23 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 23 2026
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT06994988
Start Date
October 23 2025
End Date
October 23 2026
Last Update
August 11 2025
Active Locations (2)
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1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
2
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814