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

• ClinicalTrials.gov Identifier: NCT05537662
• Recruitment Status: Not yet recruiting
• First Posted: September 13, 2022
• Last Update Posted: March 27, 2023
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Chronic Pain	Device: Standard of care neuromodulation therapy (SCS or DRG)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes
• Estimated Study Start Date: March 2023
• Estimated Primary Completion Date: January 2025
• Estimated Study Completion Date: April 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Subjects using Neuromodulation Therapy (SCS or DRG); Patients will trial standard of care neuromodulation therapy (SCS or DRG), and if successful will proceed to a permanent implant.	Device: Standard of care neuromodulation therapy (SCS or DRG); Standard SCS or DRG therapy

Outcome Measures

Primary Outcome Measures :

1. The mean change in pain scores measured by the Numerical Rating Scale (NRS) at baseline and follow up at 3 months [ Time Frame: At 3 month ]
   Change in physical activity levels, pain interference and decreased sleep quality with reported pain, performance of tasks, association of facial recognition analysis with reported pain, need for reprogramming or other therapeutic interventions or termination of neuromodulation.
2. The mean change in pain scores measured by the Numerical Rating Scale (NRS) at baseline and follow up at 6 months [ Time Frame: At 6 month ]
   Change in physical activity levels, pain interference and decreased sleep quality with reported pain, performance of tasks, association of facial recognition analysis with reported pain, need for reprogramming or other therapeutic interventions or termination of neuromodulation.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).
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

Contacts

Contact: Ameya Nanivadekar; (972) 309-2103; Ameya.nanivadekar@abbott.com

Locations

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612

Contact: Daniel Torrez, BS 312-942-2741 daniel_torrez@rush.edu

Principal Investigator: Tolga Suvar, MD

Sponsors and Collaborators

Abbott Medical Devices

More Information

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT05537662
• Other Study ID Numbers: ABT-CIP-10458
• First Posted: September 13, 2022
• Last Update Posted: March 27, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Abbott Medical Devices:

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

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations