RECRUITING

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

Conditions

Chronic Pain ABT-CIP-10458 Neuromodulation System SCS Diabetic Pain DRG

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes

Quick Facts

Study Start:2023-06-06

Study Completion:2025-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05537662

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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). 11. Subject has sleep/wake schedule that would present a challenge in completing all clinical site visits or in use of the wearable devices and engagement in the surveys via the mobile device. 12. Subject is bedridden.

Inclusion Criteria

Exclusion 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.

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).
11. Subject has sleep/wake schedule that would present a challenge in completing all clinical site visits or in use of the wearable devices and engagement in the surveys via the mobile device.
12. Subject is bedridden.

Contacts and Locations

Study Contact

Bram Blomme

CONTACT

+32 (0)2 774 68 50

bram.blomme@abbott.com

Study Locations (Sites)

Rush University Medical Center

Chicago, Illinois, 60612

United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-06

Study Completion Date2025-04

Study Record Updates

Study Start Date2023-06-06

Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

ABT-CIP-10458
Chronic Pain
Neuromodulation System
SCS
Diabetic Pain
DRG

Additional Relevant MeSH Terms

Chronic Pain