Neuromodulation Therapy for Chronic Pain

(XANADO Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Abbott Medical Devices

Disqualifiers: Pregnancy, Coagulation disorder, Neuromodulation system, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Neuromodulation Therapy for Chronic Pain?

Research shows that Dorsal Root Ganglion Stimulation (DRG-S) and Spinal Cord Stimulation (SCS) are effective in relieving chronic neuropathic pain, improving mood, and enhancing quality of life for conditions like complex regional pain syndrome and failed back surgery syndrome. DRG-S is particularly noted for maintaining pain relief over time and having fewer side effects compared to traditional SCS. ^{1 2 3 4 5}

Is neuromodulation therapy, including spinal cord and dorsal root ganglion stimulation, safe for humans?

Dorsal root ganglion stimulation (DRG-S) and spinal cord stimulation (SCS) have been shown to be safe for treating chronic pain, with studies indicating they provide effective pain relief and have a lower rate of side effects compared to other methods. ^{1 2 3 4 6}

How is neuromodulation therapy for chronic pain different from other treatments?

Neuromodulation therapy, including spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation, is unique because it targets specific nerves to relieve chronic pain without relying on medications. DRG stimulation offers precise pain relief by focusing on specific nerve areas, and it can be effective even when other treatments like SCS have failed. ^{1 2 4 7 8}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

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.

Subject must provide written informed consent prior to any clinical investigation-related procedure.

Exclusion Criteria

I am unable to get out of bed.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

3 months

Regular visits for neuromodulation therapy adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Follow-up visits at 3 months and 6 months

Treatment Details

Interventions

• Neuromodulation and Nutrition therapy (Neuromodulation Therapy)
• Neuromodulation SCS or DRG therapy (Neuromodulation Therapy)
• Standard of care neuromodulation therapy (Neuromodulation Therapy)

Trial Overview 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.

Participant Groups

Group I: Subjects using Neuromodulation Therapy (SCS or DRG) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Findings from Research

Dorsal root ganglion stimulation (DRG-S) has been shown to effectively salvage pain relief in patients who did not respond to spinal cord stimulation (SCS) or lost its efficacy, with significant reductions in pain scores and opioid requirements over a median follow-up of 34 months.

In a study of 60 patients, DRG-S led to a decrease in pain ratings from 8.7 to 3.8 and improved quality of life measures, indicating that it can be a viable alternative for chronic pain management when SCS fails.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dorsal Root Ganglion Stimulation as a Salvage Therapy Following Failed Spinal Cord Stimulation. Chapman, KB., Spiegel, MA., van Helmond, N., et al.[2022]

Spinal cord stimulation of the dorsal root ganglion (DRG-SCS) significantly reduced pain by 56% after 12 months in patients with chronic neuropathic pain, with 60% of subjects experiencing over 50% pain improvement.

DRG-SCS not only provided effective pain relief but also improved mood and quality of life, with stable pain-paresthesia overlap reported throughout the year, indicating its potential advantages over traditional spinal cord stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year outcomes of spinal cord stimulation of the dorsal root ganglion in the treatment of chronic neuropathic pain. Liem, L., Russo, M., Huygen, FJ., et al.[2022]

Dorsal root ganglion (DRG) stimulation is an effective neuromodulation technique for relieving various neuropathic pain syndromes, showing similar efficacy to spinal cord stimulation (SCS) in conditions like failed back surgery syndrome and complex regional pain syndromes.

DRG stimulation has advantages over SCS and peripheral nerve stimulation (PNS), including a lower rate of electrode migration and fewer positional side effects, making it a promising option for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulation of the Dorsal Root Ganglion. Liem, L.[2022]

In a case series of 20 patients with refractory low back pain, dorsal root ganglion neurostimulation (DRG-S) was successfully tapered from 16 Hz to as low as 4 Hz while maintaining over 75% pain relief, demonstrating its efficacy at lower frequencies than previously recognized.

The study suggests that lower frequency DRG-S not only preserves pain relief and improves quality of life but also reduces energy consumption, potentially extending battery life and allowing for smaller implantable devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Very Low Frequencies Maintain Pain Relief From Dorsal Root Ganglion Stimulation: An Evaluation of Dorsal Root Ganglion Neurostimulation Frequency Tapering. Chapman, KB., Yousef, TA., Vissers, KC., et al.[2022]

A 43-year-old woman with complex regional pain syndrome (CRPS) in her distal upper extremity experienced over 70% pain relief after dorsal root ganglion (DRG) stimulation, reducing her pain from 8/10 to 4/10 on the visual analog scale.

This case suggests that DRG stimulation may be an effective treatment for difficult-to-treat pain areas in CRPS, particularly when traditional spinal cord stimulation methods are ineffective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation of the Cervical Dorsal Root Ganglion for Upper Extremity Complex Regional Pain Syndrome-Case Report. Garg, A., Danesh, H.[2022]

In a study of 66 participants with chronic pain, dorsal root ganglion (DRG) stimulation led to a significant reduction in pain levels, with average pain ratings dropping from 8.0 cm to 4.1 cm after 12 months, and 49% of subjects experiencing at least a 50% reduction in pain.

The treatment also improved functional capacity, mood, and quality of life, with a high success rate of permanent implants (86.2%) and a low incidence of complications such as infections or lead migrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Dorsal Root Ganglion Stimulation in a Prospective Dutch Cohort. Huygen, FJPM., Liem, L., Nijhuis, H., et al.[2022]

Spinal cord stimulation is a key treatment for chronic neuropathic pain, serving as a neuromodulation therapy that can help manage pain symptoms effectively.

The article outlines the criteria for determining which patients are suitable for spinal cord stimulation therapy, ensuring that the right individuals receive this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation. Love-Jones, S.[2021]

In a study of 39 patients undergoing dorsal root ganglion (DRG) stimulation for neuropathic pain, 87% reported no paresthesias, yet they experienced significant pain relief averaging 63.1% after 12 months, indicating that effective pain management can occur without the sensation of tingling.

The results suggest that DRG stimulation can provide clinically significant pain relief through mechanisms that do not rely on the generation of paresthesia, highlighting its potential as a treatment option for various pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dorsal Root Ganglion Stimulation Is Paresthesia-Independent: A Retrospective Study. Verrills, P., Mitchell, B., Vivian, D., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dorsal Root Ganglion Stimulation as a Salvage Therapy Following Failed Spinal Cord Stimulation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

One-year outcomes of spinal cord stimulation of the dorsal root ganglion in the treatment of chronic neuropathic pain. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Stimulation of the Dorsal Root Ganglion. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Very Low Frequencies Maintain Pain Relief From Dorsal Root Ganglion Stimulation: An Evaluation of Dorsal Root Ganglion Neurostimulation Frequency Tapering. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Neuromodulation of the Cervical Dorsal Root Ganglion for Upper Extremity Complex Regional Pain Syndrome-Case Report. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluating Dorsal Root Ganglion Stimulation in a Prospective Dutch Cohort. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Neuromodulation. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Dorsal Root Ganglion Stimulation Is Paresthesia-Independent: A Retrospective Study. [2022]