Actively Recruiting
External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes (XANADO)
Led by Abbott Medical Devices · Updated on 2024-07-12
30
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, longitudinal, single-center, non-randomized, open-label, post-market clinical feasibility study to assess the efficacy of neuromodulation therapies (SCS and DRG) for chronic pain patients with diabetes and investigate whether physical and physiological data collected from diabetic and pre-diabetic chronic pain patients is predictive of subjective patient-reported outcomes (PROs) and of adjustments in patient care. These assessments will be made prior to, during, and after the trial of the SCS or DRG system. The study will be carried out in the United States at a single site.
CONDITIONS
Official Title
External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes (XANADO)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must provide written informed consent before any study procedures
- Must be 18 years of age or older at enrollment
- Scheduled trial duration for the Abbott neuromodulation system is at least 7 days
- Scheduled to undergo trial of an Abbott neuromodulation system for chronic intractable back and/or leg pain at least 7 days after enrollment
- Agree to take an A1C screening test prior to enrollment with confirmed HbA1C level of 5.7% or higher
- Baseline pain Numerical Rating Scale (NRS) score of 6 or higher without stimulation
- Willing to cooperate with study requirements including all office visits
- Agree to wear wearable sensing devices (Fitbit and Freestyle Libre)
- Agree to regularly answer questionnaires for the study duration
You will not qualify if you...
- Currently enrolled or intending to participate in another competing or confounding clinical study
- Pregnant, nursing, or planning pregnancy during the study follow-up period
- Part of a vulnerable population
- Have other anatomical, medical, social, or psychological conditions that limit participation or follow-up compliance
- Current diagnosis of coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, or post-herpetic neuralgia
- Have or are scheduled to receive another neuromodulation system implantation for chronic pain
- Previously participated in a spinal cord stimulation (SCS) trial before enrolling
- Engage in professions or activities that may damage wearable sensors
- Have physical conditions making it difficult to wear wearable sensors
- Have tremors such as Parkinson's disease or familial tremors
- Have sleep/wake schedules that challenge completing visits or device use
- Are bedridden
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
B
Bram Blomme
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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