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

NCT05537662 | Recruiting DMC FDA Device

• 1 other identifier: ABT-CIP-10458
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

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

Outcome Measures

Primary Outcomes (2)

• The mean change in pain scores measured by the Numerical Rating Scale (NRS) at baseline and follow up at 3 months

  Change in pain scores measured by the NRS at baseline and follow up study visits at 3 months.

  At 3 month

• The mean change in pain scores measured by the Numerical Rating Scale (NRS) at baseline and follow up at 6 months

  Change in pain scores measured by the NRS at baseline and follow up study visits at 6 months.

  At 6 month

Study Arms (1)

Subjects using Neuromodulation Therapy (SCS or DRG)

EXPERIMENTAL

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)

Interventions

Standard of care neuromodulation therapy (SCS or DRG) DEVICE

Standard SCS or DRG therapy

Subjects using Neuromodulation Therapy (SCS or DRG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subject is enrolled, or intends to participate, in a competing or confounding clinical study, as determined by Abbott.
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
• Subject is part of a vulnerable population.
• 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.
• Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia.
• 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.
• Subject has already participated in a SCS trial period before enrolling in the study.
• Subject engages in a profession or other activity that could be damaging to the wearable sensors, as determined by the investigator.
• Subject has a physical condition that makes it difficult to wear the wearable sensors, as determined by the investigator.
• Subject has tremors (e.g. Parkinson's disease or Familial tremors).
• 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.
• Subject is bedridden.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Bram Blomme

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 13, 2022
• Study Start: June 6, 2023
• Primary Completion: January 1, 2025
• Study Completion: April 1, 2025
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)