Neurostimulation + Spinal Fusion for Chronic Pain

Recruiting at 1 trial location

Overseen By Gabi Molnar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SynerFuse, Inc

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

Compensation: Varies

Number of Visits: 4

Duration: Immediate (surgical procedure)

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new way to reduce chronic back and leg pain by using a small device that sends electrical signals to specific nerves in the spine. The device is placed during a specific type of back surgery. It aims to block pain signals from reaching the brain, helping patients who haven't found relief from other treatments. This method has been used for a long time to treat chronic pain by sending electrical signals to the spine to block pain signals from reaching the brain.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using narcotics at a high dose (100 MME or more per day), you may not be eligible to participate.

What data supports the effectiveness of the treatment Neurostimulation + Spinal Fusion for Chronic Pain?

Research shows that dorsal root ganglion (DRG) neurostimulation can effectively reduce chronic pain, with a study reporting 81.2% of patients experiencing significant pain relief. Additionally, spinal fusion with electrical bone growth stimulation has shown high success rates in achieving bone fusion, which is crucial for reducing pain caused by abnormal spinal motion. ^{1 2 3 4 5}

Is neurostimulation with spinal fusion generally safe for humans?

Studies on dorsal root ganglion (DRG) neurostimulation, a similar treatment, show it is generally safe for treating chronic pain, with no major neurological issues reported. However, there can be complications during device placement, such as retained catheter fragments, which may require additional surgery to fix. ^{1 4 6 7 8}

How is the Neurostimulation + Spinal Fusion treatment different from other treatments for chronic pain?

This treatment is unique because it combines dorsal root ganglion stimulation (DRG-S) with spinal fusion, offering targeted pain relief by focusing on specific nerve areas, unlike traditional spinal cord stimulation (SCS) which can lack spatial precision. DRG-S is particularly effective for focal pain and can be more comfortable for patients due to reduced positional effects. ^{1 2 6 9 10}

Eligibility Criteria

This trial is for adults over 21 with chronic lower back or leg pain that hasn't improved after at least 3 months of treatment, who now need spinal fusion surgery. Candidates should not have had previous spinal fusions at the same level, be pregnant, involved in other studies, require future MRIs, have osteoporosis or active infections.

Inclusion Criteria

Willing and able to comply with study-related requirements

It has been over 6 months since my last spine surgery.

I have had severe lower back or leg pain for over 3 months that hasn't improved with basic treatments.

Exclusion Criteria

Allergies to system components

I currently have an infection.

You might need to have an MRI in the future.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo DRG neurostimulation and spinal fusion procedure

Immediate (surgical procedure)

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and effectiveness of the treatment

12 months

Multiple visits at 3, 6, and 12 months post-op

Long-term follow-up

Participants' use of analgesics, disability, neurological status, quality of life, and device migration are assessed

12 months

Treatment Details

Interventions

• DRG Neurostimulation
• Spinal Fusion

Trial Overview The study tests the safety and effectiveness of DRG stimulation combined with spinal fusion surgery in patients suffering from persistent back and/or leg pain. It involves placing a neurostimulator during the surgical procedure to manage pain.

Participant Groups

Group I: DRG Neurostimulation with Spinal Fusion Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

SynerFuse, Inc

Lead Sponsor

Trials

1

Recruited

20+

Findings from Research

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 (DRG) stimulation is an emerging treatment for neuropathic pain, but complications during the placement of the device can occur, as illustrated by a case where a catheter fragment was retained in the spinal canal.

The patient required a laminectomy to remove the retained catheter, highlighting the need for further investigation into the safety and long-term complications associated with DRG stimulation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retained catheter during placement of dorsal root ganglion stimulator: a case report. Kohli, G., Amin, S., Herschman, Y., et al.[2020]

References

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

A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of Spinal Cord Stimulation vs. Dorsal Root Ganglion Stimulation vs. Association of Both in Patients with Refractory Chronic Back and/or Lower Limb Neuropathic Pain: An International, Prospective, Randomized, Double-Blinded, Crossover Trial (BOOST-DRG Study). [2022]

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

Direct current electrical bone growth stimulation for spinal fusion. [2019]

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

Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. [2022]

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

The use of implantable direct current stimulation in multilevel spinal fusion without instrumentation. A prospective clinical and radiographic evaluation with long-term follow-up. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Treatment of FBSS Low Back Pain with a Novel Percutaneous DRG Wireless Stimulator: Pilot and Feasibility Study. [2022]

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

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

8. England pubmed.ncbi.nlm.nih.gov

Retained catheter during placement of dorsal root ganglion stimulator: a case report. [2020]

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

Dorsal Root Ganglion Stimulation to Treat Focal Postsurgical and Diffuse Chronic Pain: A Case Report. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Effectiveness of Combined Dorsal Root Ganglion and Spinal Cord Stimulation: A Retrospective, Single-Centre Case Series for Chronic Focal Neuropathic Pain Effectiveness of Combined Stimulation. [2023]