Dorsal Root Ganglion Stimulation for Spinal Cord Injury

PJ
Overseen ByPeter J. Grahn, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Peter J. Grahn, Ph.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment using a device to stimulate nerves near the spine. It targets individuals with spinal cord injuries below the tenth thoracic vertebra. The goal is to determine if this treatment can improve muscle movement and function in the legs. Individuals who sustained a spinal cord injury over a year ago and still have some muscle reflexes might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatment options.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the research team to understand any specific requirements.

What prior data suggests that this device is safe for spinal cord injury patients?

Studies have shown that stimulating the dorsal root ganglion (DRG) safely treats chronic pain. Research suggests that DRG stimulation's safety is comparable to spinal cord stimulation, with similar risks such as device movement or breakage.

In several studies, patients experienced positive outcomes with DRG stimulation, with over a third reporting significant pain reduction after 12 months. Although the device might need removal over time, DRG stimulation is generally considered safe and effective.

DRG stimulation has FDA approval for certain types of chronic pain, indicating a strong safety record for those cases. However, individual experiences may vary, so discussing any concerns with a healthcare professional is advisable.12345

Why are researchers excited about this trial?

Dorsal Root Ganglion Stimulation is unique because it targets the nerve clusters directly involved in transmitting pain and sensory signals—something current standard treatments, like physical rehabilitation and medication, don't specifically do. This neurostimulator works by sending electrical impulses to the dorsal root ganglion, potentially offering more precise pain and sensory control for spinal cord injury patients. Researchers are excited because this approach could provide improved sensation and pain relief, possibly enhancing quality of life for individuals with injuries below the T10 vertebra, where traditional methods may fall short.

What evidence suggests that dorsal root ganglion stimulation is effective for spinal cord injury?

Research has shown that the Abbott Dorsal Root Ganglion (DRG) Stimulator can help reduce pain. Studies found that over 80% of patients experienced significant pain reduction, with levels dropping to as low as 1.7 in some cases. This treatment is particularly effective for long-term nerve pain, which results from nerve damage. Reports indicate that DRG stimulation improves quality of life more effectively than traditional spinal cord stimulation methods. Additionally, the treatment has demonstrated safety and effectiveness over extended periods. In this trial, researchers will treat one adult patient with a spinal cord injury below T10 using DRG stimulation. While most current data focuses on pain relief, these findings suggest potential benefits for issues related to spinal cord injuries.34678

Who Is on the Research Team?

PJ

Peter J. Grahn, Ph.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for people with lower motor neuron injuries, such as those from spinal cord injury or diseases like ALS. Participants should have damage affecting movement in their legs and be able to take part in a short rehabilitation program.

Inclusion Criteria

Greater than 1 year post-SCI
I have working spinal reflexes below my injury in at least one muscle.
My spinal cord injury is classified as AIS grade A, B, C, or D.
See 2 more

Exclusion Criteria

Non-MRI-compatible implanted medical devices
Other implanted stimulation devices (e.g., deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, etc.)
Any illness or condition which may compromise patient's ability to comply with the protocol, patient safety, or validity of data collected during this study
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dorsal root ganglion stimulation and undergo a 10-day rehabilitation program

10 days

Follow-up

Participants are monitored for changes in ASIA Impairment Scale, NBSS, NBD, and sexual function scores

14 days

What Are the Treatments Tested in This Trial?

Interventions

  • Abbot Dorsal Root Ganglion Neurostimulator

Trial Overview

The study tests a device called the Abbot Dorsal Root Ganglion Neurostimulator, which is temporarily implanted to stimulate nerves in the spine. Researchers will see how this affects muscle activity and leg function during a 10-day rehab program.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Dorsal Root Ganglion StimulationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Peter J. Grahn, Ph.D.

Lead Sponsor

Trials
1
Recruited
30+

Citations

Effectiveness and Safety of Dorsal Root Ganglion Stimulation ...

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, ...

Spinal Cord and Dorsal Root Ganglion Stimulation

Spinal cord stimulation delivers low-voltage electrical stimulation to the dorsal columns of the spinal cord to block the sensation of pain; this is achieved ...

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 ...

Noninfectious Complications of Dorsal Root Ganglion ...

Dorsal root ganglion stimulation (DRGS) has emerged as a promising treatment for chronic neuropathic pain. However, its safety and complications are not ...

Proclaim™ DRG System

Dorsal root ganglion stimulation (DRGS) for the treatment of chronic neuropathic pain: a single-center study with long-term prospective results in 62 cases.

Safety Analysis of Dorsal Root Ganglion Stimulation in ... - PMC

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

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 ...

Spinal Cord Stimulation (SCS) and Dorsal Root Ganglion ( ...

Most of the studies reported positive results with DRG stimulation ... Safety and Efficacy of the Spinal Modulation™ AXIUM™ Neurostimulator System ...