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External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes (XANADO) | Clinical Trials | Clareo Health

RECRUITINGNA

External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes (XANADO)

External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes

NCT05537662•Abbott Medical Devices

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject must provide written informed consent prior to any clinical investigation-related procedure.
•2. Subject is at least 18 years of age or older at the time of enrollment.
•3. Subject's scheduled trial duration for the Abbott neuromodulation system is at least 7 days.
•4. Subject is scheduled to undergo trial of an Abbott neuromodulation system for chronic intractable back and/or leg pain at least 7 days after enrollment and commencement of the baseline data collection period.
•5. Subject agrees to take an A1C screening test prior to study enrollment and has a confirmed HbA1C level ≥ 5.7%.
•6. Subject has a baseline (with no stimulation) pain NRS of ≥ 6.
•7. Subject is willing to cooperate with the study requirements including completion of all office visits.
•8. Subject agrees to wear the wearable sensing devices (Fitbit® and Freestyle Libre).
•9. Subject agrees to answer questionnaires regularly for the duration of the study.

Exclusion Criteria

•1. Subject is enrolled, or intends to participate, in a competing or confounding clinical study, as determined by Abbott.
•2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
•3. Subject is part of a vulnerable population.
•4. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
•5. Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia.
•6. Subject has, or is scheduled to receive, implantation of another neuromodulation system (e.g. DRG or SCS system or intrathecal pump) to address their chronic pain.
•7. Subject has already participated in a SCS trial period before enrolling in the study.
•8. Subject engages in a profession or other activity that could be damaging to the wearable sensors, as determined by the investigator.
•9. Subject has a physical condition that makes it difficult to wear the wearable sensors, as determined by the investigator.
•10. Subject has tremors (e.g. Parkinson's disease or Familial tremors).
+2 more criteria

Locations (1)

Rush University Medical Center

Chicago, Illinois, United States

Key Dates

Start Date

June 6, 2023

Primary Completion Date

January 1, 2025

Completion Date

April 1, 2025

Last Updated

July 12, 2024

Enrollment

ESTIMATED participants

Conditions

Chronic Pain

Interventions

Standard of care neuromodulation therapy (SCS or DRG)

DEVICE

Contacts

Bram Blomme

CONTACT

+32 (0)2 774 68 50 bram.blomme@abbott.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes (XANADO)

Inclusion Criteria

Exclusion Criteria

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