PFM-Guided Cortical Stimulation for Neuropathic Pain

Overseen By Matthew Maple

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Minnesota

Disqualifiers: Pregnancy, Uncontrolled psychiatric illness, Seizure disorder, Substance use disorder, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for central neuropathic pain using PFM-guided cortical stimulation, a type of brain stimulation therapy. Neuropathic pain is chronic pain resulting from nervous system damage, and this treatment targets individuals who haven't found relief from other methods. Suitable candidates for this trial have experienced severe neuropathic pain for over six months without improvement from other medical treatments. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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

The trial requires that your medication doses be stable for at least 30 days before the study begins, meaning no changes in your current medications during that time. However, if you are on anticoagulation therapy, you may need to temporarily stop it for about 3 weeks for the surgery.

What prior data suggests that PFM-guided cortical stimulation is safe for treating central neuropathic pain?

Research has shown that PFM-guided cortical stimulation is being studied as a treatment for central neuropathic pain. This treatment uses a device to stimulate specific brain areas to help reduce pain. It is important to note that this method is still in the early stages of testing for safety and effectiveness.

Some safety information is available from similar treatments. For instance, Magnetic Peripheral Nerve Stimulation, which is somewhat related, has received FDA approval for managing chronic pain. This suggests that similar techniques have been found reasonably safe for some conditions.

Since the trial is in phase 1, the main focus is on assessing the treatment's safety for people. Researchers are closely monitoring for any side effects. Although there is limited data on PFM-guided cortical stimulation specifically, the careful monitoring in this phase helps ensure participant safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about PFM-guided cortical stimulation for neuropathic pain because it offers a new approach to managing this challenging condition. Unlike traditional treatments like medications or physical therapy, this method uses advanced technology called the Abbott Eterna IPG and Lamitrode 44 paddles to directly stimulate specific areas of the brain's cortex. This precision targeting could potentially provide better pain relief with fewer side effects. Additionally, the use of cortical stimulation might offer long-lasting benefits by altering the brain's pain pathways, which is a novel mechanism compared to existing therapies.

What evidence suggests that PFM-guided cortical stimulation is effective for neuropathic pain?

Research has shown that PFM-guided brain stimulation, which participants in this trial will receive, might help treat central neuropathic pain. In studies focused on pain relief, similar methods have shown promising results. For instance, magnetic stimulation on nerves greatly reduced pain for many participants. This suggests that targeting specific brain areas with stimulation could significantly lessen pain. While more research is needed, early findings offer hope for those dealing with this type of pain. ^{1 2 6 7 8}

Who Is on the Research Team?

David Darrow, MD

Principal Investigator

University of Minnesota

Alexander Herman, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

Adults aged 22 or older with chronic neuropathic pain for over 6 months, rating their pain intensity at 6 or higher. They must have stable medication doses, speak/read English, and women of childbearing age should use contraception. Excluded are those with recent seizures, high suicide risk, ongoing litigation related to pain/injury, allergies to implant materials, conditions increasing surgery risks like uncontrolled hypertension or severe diabetes.

Inclusion Criteria

I am 22 years old or older.

I have had nerve pain for more than 6 months.

My average pain level has been 6 or higher in the last month.

Exclusion Criteria

I have had a seizure in the past year or have a history of epilepsy.

Modified Scale for Suicidal Ideation Score of greater than or equal to 21

Active, pending, or planned litigation or workman's compensation claim related to the pain/injury. Current receipt of disability benefits, without a dispute or litigation, is not an exclusion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo PFM-guided cortical stimulation using Abbott Eterna IPG and Lamitrode 44 paddles

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PFM-guided cortical stimulation

Trial Overview The SENAP trial is testing the effectiveness of PFM-guided cortical stimulation in treating central neuropathic pain. Participants will undergo a procedure where a device is implanted to stimulate specific brain networks associated with pain control.

How Is the Trial Designed?

Group I: PFM-guided cortical stimulation Experimental Treatment 1 Intervention

Abbott Eterna IPG and Lamitrode 44 paddles with accessory extensions and clinical programmers

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12409336/

Efficacy and Safety of Magnetic Peripheral Nerve Stimulation ... Of these, a profound (>80%) reduction of pain was experienced by 62.5% of participants in the CMM + mPNS group, and 38.5% in the Crossover group ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07057206

Simultaneous Engagement of Networks for Alleviating Pain ... This trial is investigating the acceptability and efficacy of PFM-guided cortical stimulation for the treatment of central neuropathic pain. Official Title.

3. patlynk.com patlynk.com/trial/NCT07057206

Pain Alleviation through Simultaneous Network ... The study focuses on using a technique called PFM-guided cortical stimulation to see if it can reduce pain effectively. ... data to guide future research and ...

4. nature.com nature.com/articles/sc201687

rTMS of the prefrontal cortex has analgesic effects on ... The findings of this preliminary study in a small patient sample suggest that rTMS of the PMC/DLPFC may be effective in relieving neuropathic ...

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08450-w

Reducing pain by improving brain and muscle activity ... - Trials This study aims to provide evidence that non-invasive stimulation targeting the motor cortex may help reduce IC/BPS pain.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37638720/

Long-Term Results of Cortical Motor Stimulation for ... Conclusion: CMS might show long-term efficacy for neuropathic pain syndromes, with the effect on PTN being more robust in the long term.

7. dosenbachlab.wustl.edu dosenbachlab.wustl.edu/media/papers/Pain_Perspective_df.pdf

Title: An action networks model for pain reveals cortical ... Neuromodulation of primary motor cortex and dorsolateral prefrontal cortex (dlPFC) alleviates neuropathic pain in some cases, though the mechanism remains ...

8. withpower.com withpower.com/clinical-trials/for-neuropathic-pain

Top Neuropathic Pain Clinical Trials | Power This trial is investigating the acceptability and efficacy of PFM-guided cortical stimulation for the treatment of central neuropathic pain. No Placebo Group.