Neurostimulation for Chronic Pain

(REALITY Trial)

Recruiting at 38 trial locations

Overseen By Sonar Pradhan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Disqualifiers: Competing study, Intrathecal pump, Neuromodulation device, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how Abbott's neurostimulation systems assist people with chronic pain, focusing on real-world results over time, particularly safety and effectiveness. The trial includes two groups: one using spinal cord stimulation and the other using dorsal root ganglion stimulation. It suits individuals with severe pain (rated 6 or higher on a pain scale) who plan to have an Abbott neurostimulator implanted soon. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits more patients.

Do I have to stop taking my current medications for the trial?

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

What is the safety track record for Abbott's neurostimulation systems?

Research has shown that Abbott's neurostimulation systems are safe for managing chronic pain. Studies indicate that spinal cord stimulation (SCS) helps reduce pain in the back and limbs. When used properly, it is usually well-tolerated, though it may not suit individuals with certain health issues, such as active infections.

For dorsal root ganglion (DRG) stimulation, which targets pain from specific injuries, post-release safety data suggest it is effective and safe for most people. Both systems have FDA approval for specific uses, indicating they have passed safety checks for those conditions. However, potential trial participants should discuss their health history with their doctors to ensure these treatments are appropriate for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Abbott's Neurostimulation Systems because they offer a unique approach to managing chronic pain. Unlike traditional treatments that rely heavily on medications like opioids, spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation provide targeted electrical impulses to specific nerves, potentially reducing pain with fewer side effects. These neurostimulation systems can be tailored to the individual, allowing for personalized pain management and possibly improving quality of life for patients who haven't found relief with standard therapies.

What evidence suggests that Abbott's neurostimulation systems are effective for spinal cord and dorsal root ganglion stimulation?

This trial will compare Abbott's spinal cord stimulation (SCS) systems with dorsal root ganglion (DRG) stimulation. Studies have shown that Abbott's SCS systems provide significant, long-term pain relief, with 67% of patients experiencing a substantial reduction in pain after two years and many reporting improved quality of life. In contrast, Abbott's DRG stimulation has proven effective for conditions like complex regional pain syndrome, with research indicating that over 80% of patients experienced significant pain relief after one year. Both treatments send electrical signals to the nervous system to help reduce pain, making them promising options for managing chronic pain. ^{2 6 7 8 9}

Who Is on the Research Team?

Devyani Nanduri

Principal Investigator

Abbott Medical Devices Neuromodulation

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Subject is scheduled to have an Abbott neurostimulation system implanted within 60 days of baseline.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an implantable Abbott neurostimulation system

5 years

Regular follow-up visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Follow-up visits to assess clinical improvement and adverse events

Long-term follow-up

Participants continue to be monitored for long-term safety and effectiveness

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Abbott's Neurostimulation Systems

How Is the Trial Designed?

Group I: Spinal cord stimulation (SCS) Experimental Treatment 1 Intervention

Subjects using Abbott SCS systems

Group II: Dorsal root ganglion stimulation (DRG) Experimental Treatment 1 Intervention

Subjects using Abbott DRG system

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

Citations

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

Effectiveness and Safety of Dorsal Root Ganglion ... The end result of electrical stimulation on the DRG neurons is to stabilize and decrease hyperexcitability 15. In addition, to our knowledge, all in vitro and ...

2. neuromodulation.abbott neuromodulation.abbott/us/en/healthcare-professionals/hcp-chronic-pain/proclaim-drg-neurostimulator-system.html

Proclaim™ DRG System Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1094715922013472

Comparing the Efficacy of Dorsal Root Ganglion ... Three patients with DRG stimulation had a negative trial and were lost to follow-up. The average pain reduction was 50% in the DRG stimulation and crossover ...

4. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(21)00012-X/fulltext

Three-Year Outcomes After Dorsal Root Ganglion ... Twenty-seven patients were trialed with a DRG neurostimulation system for PNI; trial success (defined as ≥50% pain relief) was 85%, and 23 patients received a ...

5. abbott.mediaroom.com abbott.mediaroom.com/2017-01-17-New-Data-Confirms-Abbotts-Dorsal-Root-Ganglion-Stimulation-Offers-Greater-Treatment-Success-over-Traditional-Spinal-Cord-Stimulation

New Data Confirms Abbott's Dorsal Root Ganglion Stimulation ... Reduced paresthesia: At 12 months, more than a third of patients who received DRG stimulation were experiencing greater than 80 percent pain ...

6. neuromodulation.abbott neuromodulation.abbott/us/en/important-safety-information.html

Important Safety Information Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections.

7. abbott.mediaroom.com abbott.mediaroom.com/press-releases?item=124695

Abbott MediaRoom - Press Releases Abbott Introduces Next-Generation Delivery System to Streamline Electrode Placement During Dorsal Root Ganglion Stimulator Implantations.

8. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=19586102&pc=PMP

DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM DORSAL ROOT GANGLION (DRG) NEUROSTIMULATION SYSTEM; DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF.

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

Safety Analysis of Dorsal Root Ganglion Stimulation in the ... A postmarket surveillance analysis was conducted to generate performance and safety data for both DRG and SCS stimulation. Data, generously provided by Abbott ...