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Neuromodulation Therapy

Neuromodulation Therapy for Chronic Pain (XANADO Trial)

N/A

Waitlist Available

Research Sponsored by Abbott Medical Devices

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is at least 18 years of age or older at the time of enrollment.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3 month

Awards & highlights

XANADO Trial Summary

This trial will monitor the efficacy of two types of neuromodulation therapies, SCS and DRG, for chronic pain patients with comorbidities such as diabetes and hypertension. Nutrition interventions will also be evaluated to see their effect on patient outcomes.

Who is the study for?

This trial is for adults over 18 with diabetes or pre-diabetes experiencing chronic pain, who have a pain score of at least 6 and an HbA1C level ≥ 5.7%. Participants must consent to wear Fitbit® and Freestyle Libre devices, complete questionnaires, and follow study visits. Exclusions include pregnancy, other neuromodulation treatments, conditions affecting sensor use, irregular sleep/wake patterns that affect participation, being bedridden or part of vulnerable populations.Check my eligibility

What is being tested?

The XANADO study tests the effectiveness of standard neuromodulation therapies (SCS or DRG) in managing chronic pain among diabetic patients. It also examines if data from wearable devices can predict patient-reported outcomes and inform care adjustments. The non-randomized trial involves regular assessments before, during, and after therapy trials.See study design

What are the potential side effects?

While specific side effects are not listed for this observational study on neuromodulation therapies like SCS or DRG systems; generally such interventions may cause discomfort at the stimulation site, unwanted changes in nerve function leading to muscle weakness or sensory disturbances.

XANADO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My usual pain level is 6 or higher without taking anything for it.

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I am scheduled to use the Abbott system for at least 7 days.

XANADO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain

XANADO Trial Design

1Treatment groups

Experimental Treatment

Group I: Subjects using Neuromodulation Therapy (SCS or DRG)Experimental Treatment1 Intervention

Patients will trial standard of care neuromodulation therapy (SCS or DRG), and if successful will proceed to a permanent implant.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor

638 Previous Clinical Trials

404,158 Total Patients Enrolled

17 Trials studying Chronic Pain

3,232 Patients Enrolled for Chronic Pain

Media Library

Neuromodulation and Nutrition therapy (Neuromodulation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05537662 — N/A

Chronic Pain Research Study Groups: Subjects using Neuromodulation Therapy (SCS or DRG)

Chronic Pain Clinical Trial 2023: Neuromodulation and Nutrition therapy Highlights & Side Effects. Trial Name: NCT05537662 — N/A

Neuromodulation and Nutrition therapy (Neuromodulation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05537662 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for prospective participants in this clinical trial?

"Based on the info hosted by clinicaltrials.gov, this medical trial is not currently recruiting individuals. The first posting was dated September 30th 2022 and last updated September 9th 2022. Nevertheless, there are 403 other trials in need of participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "External Sensing and Neuromodulation to Assess Diabetic Pain Outcomes (XANADO)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05537662.