External Sensing and Neuromodulation to Assess Pain Comorbidity Outcomes (XANADU)

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05537662
Collaborator
(none)
120
1
2
48
2.5

Study Details

Study Description

Brief Summary

The purpose of this prospective, longitudinal, multi-center, non-randomized, multi-arm, open-label, post-market study is to monitor the efficacy of neuromodulation therapies (SCS and DRG) for chronic pain patients with common comorbidities such as diabetes and hypertension and evaluate the effect of nutrition interventions on patient outcomes during the neuromodulation trial and permanent implant period. The study is planned to be conducted in upto 5 sites of the United States.

Condition or Disease Intervention/Treatment Phase
  • Device: Neuromodulation SCS or DRG therapy.
  • Device: Neuromodulation and Nutrition therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
External Sensing and Neuromodulation to Assess Pain Comorbidity Outcomes
Anticipated Study Start Date :
Sep 30, 2022
Anticipated Primary Completion Date :
Mar 30, 2026
Anticipated Study Completion Date :
Sep 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Subjects using Neuromodulation SCS or DRG therapy

Patients will receive standard SCS or DRG therapy during the trial and permanent implant period with no additional nutrition supplements.

Device: Neuromodulation SCS or DRG therapy.
Standard SCS or DRG therapy

Experimental: Subjects using Neuromodulation and Nutrition therapy

Patients will be provided Ensure® Surgery Immunonutrition Shake for daily consumption during the trial period. Additionally, patients from this arm that proceed to permanent implant will receive Abbott Juven® Therapeutic Nutrition Powder for twice daily consumption from 2 weeks post permanent implant through 6 months.

Device: Neuromodulation and Nutrition therapy
Ensure® Surgery Immunonutrition Shake for daily consumption and Abbott Juven® Therapeutic Nutrition Powder twice daily for patients that proceed to permanent implant.

Outcome Measures

Primary Outcome Measures

  1. The mean change in pain scores measured by the Numerical Rating Scale (NRS) at baseline and follow up study visits at 1 month [At 1 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 3 months [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.

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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 is scheduled to undergo trial of an Abbott neuromodulation system for chronic intractable pain at least 7 days after enrollment and commencement of the baseline data collection period.

  4. Subject's scheduled trial duration for the Abbott neuromodulation system is at least 7 days.

  5. Subject has a baseline (with no stimulation) pain NRS of ≥ 6.

  6. Subject is willing to cooperate with the study requirements including completion of all office visits.

  7. Subject agrees to wear the wearable sensing devices (Apple watch®, and Oura™ Ring or Fitbit®).

  8. 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 or uncontrolled diabetes mellitus.

  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 engages in a profession or other activity that could be damaging to the wearable sensors, as determined by the investigator.

  8. Subject has a physical condition that makes it difficult to wear the wearable sensors, as determined by the investigator.

  9. Subject has tremors (e.g. Parkinson's disease or Familial tremors).

  10. 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.

  11. Subject is bedridden.

Protocol-Specific Screening Exclusion Criteria

  1. Subjects reports a history of allergy to any component in Ensure Surgery product or Juven Nutrition powder will be excluded from the N2 arm of the study.

  2. Subject reports gastrointestinal disorder (severe chronic diarrhea, nausea, vomiting) that in the opinion of the principal investigator or physician would preclude ingestion of the study product; an obstruction of the gastrointestinal tract, inflammatory bowel disease; short bowel syndrome or other major gastrointestinal disease.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rush University Medical Center Chicago Illinois United States 60612

Sponsors and Collaborators

  • Abbott Medical Devices

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT05537662
Other Study ID Numbers:
  • ABT-CIP-10458
First Posted:
Sep 13, 2022
Last Update Posted:
Sep 13, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2022