Neuromodulation Therapy for Chronic Pain

(XANADO Trial)

Overseen By Bram Blomme

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Disqualifiers: Pregnancy, Coagulation disorder, Neuromodulation system, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests neuromodulation therapy, including Spinal Cord Stimulation and Dorsal Root Ganglion Stimulation, to determine its effectiveness in alleviating chronic pain associated with diabetes. Researchers aim to discover whether data on physical and health conditions can predict the treatment's success. Individuals with ongoing back or leg pain, diabetes or pre-diabetes, and a willingness to wear devices like a Fitbit and complete questionnaires may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance chronic pain management for many.

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 prior data suggests that neuromodulation therapy is safe for chronic pain patients with diabetes?

Research has shown that treatments like spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation are generally safe for managing chronic pain. Studies have found that DRG stimulation works well and is well-tolerated by patients. Many reported a significant reduction in pain, with some pain scores dropping to as low as 1.7. The responder rate, indicating how many people felt relief, reached as high as 80% for foot and groin pain, suggesting that most found it helpful.

Similarly, researchers have studied SCS alongside other treatments and proven its effectiveness in managing chronic pain. Patients using these therapies often notice improvements in their pain levels over time. Overall, both SCS and DRG therapies appear to be safe options for those dealing with ongoing pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for chronic pain, which generally involves medications and physical therapy, neuromodulation therapy offers a different approach by targeting the nervous system directly. This treatment uses devices to send electrical impulses to specific nerves, potentially altering pain signals before they reach the brain. Researchers are particularly excited about neuromodulation because it can provide pain relief without the need for drugs, reducing the risk of side effects and dependency. Moreover, the therapy can be tailored to each patient, potentially offering a more personalized and effective solution for managing chronic pain.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Research has shown that treatments like spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy can effectively manage chronic pain. In this trial, participants will use standard-of-care neuromodulation therapy, which includes SCS or DRG. Studies have found that these treatments can provide lasting pain relief and improve mood and quality of life for up to a year. Specifically, one study found that DRG therapy is a safe and long-lasting option for nerve pain, with many patients experiencing less pain. Over the years, SCS has become one of the most effective ways to treat chronic pain. These therapies offer hope for those dealing with ongoing pain issues. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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

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.

I agree to regularly fill out questionnaires for the study.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Neuromodulation and Nutrition therapy
• Neuromodulation SCS or DRG therapy
• Standard of care 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.

How Is the Trial Designed?

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.

Neuromodulation and Nutrition therapy is already approved in United States, European Union for the following indications:

Approved in United States as Neuromodulation therapy for:

• Chronic pain in diabetic patients
• Painful diabetic neuropathy

Approved in European Union as Spinal Cord Stimulation (SCS) for:

• Chronic pain
• Painful diabetic neuropathy

Approved in United States as Dorsal Root Ganglion (DRG) Stimulation for:

• Chronic pain
• Painful diabetic neuropathy

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

Published Research Related to This Trial

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 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]

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 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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25145467/

One-year outcomes of spinal cord stimulation of the dorsal ... This report describes the maintenance of pain relief, improvement in mood, and quality of life through 12 months.

2. sciencedirect.com sciencedirect.com/science/article/pii/S109471592100012X

Three-Year Outcomes After Dorsal Root Ganglion ... DRG neuromodulation appears to be a safe, effective, and durable option for treating neuropathic pain caused by PNI.

3. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(21)01641-X/abstract

One-Year Outcomes of Spinal Cord Stimulation of the ... Spinal cord stimulation of the dorsal root ganglion (DRG-SCS) is a new therapy for treating chronic neuropathic pain. Previous work has demonstrated the ...

4. janesthanalgcritcare.biomedcentral.com janesthanalgcritcare.biomedcentral.com/articles/10.1186/s44158-024-00219-6

addressing persistent doubts in spinal cord stimulation Over the past 50 years, spinal cord stimulation (SCS) has emerged as one of the most effective treatments for chronic pain.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7079258/

Effectiveness and Safety of Dorsal Root Ganglion ... Our pooled analysis showed a pain score for primary affected region ranging from 1.7 (groin) to 3.0 (buttocks) and responder rates of 80% for foot and groin, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7065079/

Safety Analysis of Dorsal Root Ganglion Stimulation in the ... Stimulation of the dorsal root ganglion (DRG) in the treatment of chronic, intractable pain has shown excellent clinical results in multiple published studies.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2826172

Spinal Cord Stimulation vs Medical Management for ... This systematic review and network meta-analysis evaluates the efficacy associated with conventional and novel spinal cord stimulation ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1094715922009047

AS05. Spinal Cord / AS05a. Pain O091 / #618 REAL- ... Neurostimulation through the spinal cord or the dorsal root ganglion effectively treats chronic pain. 6M data shows improvements across pain outcomes and ...