Your session is about to expire
← Back to Search
Neuromodulation Therapy
Neuromodulation Therapy for Chronic Pain (XANADO Trial)
N/A
Recruiting
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.
Must not have
Subject is bedridden.
Subject has tremors (e.g. Parkinson's disease or Familial tremors).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 month
Awards & highlights
Summary
This trial is testing electrical treatments that change how nerves send pain messages to the brain. It focuses on people with diabetes or pre-diabetes who have chronic pain. The goal is to see if these treatments can reduce pain and improve patient care. Electrical nerve stimulation is used to alleviate pain by administering pulsed electrical currents through the skin.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My usual pain level is 6 or higher without taking anything for it.
Select...
I am scheduled to use the Abbott system for at least 7 days.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to get out of bed.
Select...
I experience tremors, such as those from Parkinson's disease.
Select...
I am getting or have a device implanted for my chronic pain.
Select...
I have a bleeding disorder or severe nerve pain from shingles.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain
Pain
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Spinal Cord Stimulation (SCS) and Dorsal Root Ganglion (DRG) Stimulation are neuromodulation techniques that treat chronic pain by altering pain signal transmission in the nervous system. These treatments use electrical impulses to modulate neural activity, which can inhibit the transmission of pain signals to the brain.
This mechanism is significant for chronic pain patients as it offers targeted pain relief, potentially reducing the need for opioid medications and their associated risks. By directly addressing the neural pathways involved in pain perception, SCS and DRG provide an effective alternative for managing chronic pain, improving patients' quality of life.
A narrative review and future considerations of spinal cord stimulation, dorsal root ganglion stimulation and peripheral nerve stimulation.
A narrative review and future considerations of spinal cord stimulation, dorsal root ganglion stimulation and peripheral nerve stimulation.
Find a Location
Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
649 Previous Clinical Trials
411,017 Total Patients Enrolled
18 Trials studying Chronic Pain
3,252 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am unable to get out of bed.You agree to take a blood sugar test before joining the study, and your test shows that your HbA1C level is 5.7% or higher.I agree to regularly fill out questionnaires for the study.My usual pain level is 6 or higher without taking anything for it.I am willing to follow all study requirements and attend all visits.I experience tremors, such as those from Parkinson's disease.I am scheduled for a trial with an Abbott system for my chronic back or leg pain.I am getting or have a device implanted for my chronic pain.I am scheduled to use the Abbott system for at least 7 days.You have already taken part in a trial for the study's treatment before.I have a bleeding disorder or severe nerve pain from shingles.
Research Study Groups:
This trial has the following groups:- Group 1: Subjects using Neuromodulation Therapy (SCS or DRG)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger