Deep Brain Stimulation for Chronic Pain

(EPR Pain Trial)

Overseen By Markey Olson, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Joseph's Hospital and Medical Center, Phoenix

Disqualifiers: Dementia, Coagulopathies, Depression, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for patients whose pain is not responsive to medication, it might be possible to continue your current medications. Please consult with the trial coordinators for specific guidance.

What data supports the effectiveness of the treatment Deep Brain Stimulation for chronic pain?

Deep Brain Stimulation (DBS) has shown success in treating chronic pain, especially in patients with pain after amputation, stroke, or multiple sclerosis, with long-term good results in 50% to 80% of patients. Although its use for chronic pain has been controversial, recent advancements in technology and patient selection have improved outcomes in selected cases. ^{1 2 3 4 5}

Is deep brain stimulation generally safe for humans?

Deep brain stimulation (DBS) has been used for various conditions, including chronic pain and movement disorders, with generally acceptable safety levels. While complications like intracranial bleeding can occur, they are infrequent, and the technology has advanced to reduce risks over time. ^{2 5 6 7 8}

How is the treatment Deep Brain Stimulation (DBS) unique for chronic pain?

Deep Brain Stimulation (DBS) is unique for chronic pain because it involves surgically implanting electrodes in specific brain areas to modulate pain signals, making it a last-resort option for patients who do not respond to other treatments. Unlike medications or less invasive therapies, DBS directly targets brain structures involved in pain processing, offering potential relief for those with severe, treatment-resistant pain. ^{1 3 4 5 6}

What is the purpose of this trial?

Over the last 30 years, deep brain stimulation (DBS) has allowed tens of thousands of patients to receive relief of neurological symptoms that were refractory to standard medical treatment. Furthermore, by providing a rare window into the electrophysiological activity of the awake, human brain, DBS has facilitated invaluable advances in scientific understanding. These advances have then, in turn, allowed for further therapies to be developed for an ever growing population of patients that benefit from DBS therapy. This study hopes to add to this growing body of knowledge by implanting leads within, and recording from, the sensory thalamus and periaqueductal gray (PAG) in patients with chronic pain. Specifically, we hope to establish the long-term safety of DBS leads within the periaqueductal gray and sensory thalamus for the treatment of chronic pain. Furthermore, by recording from the electrodes of DBS patients implanted for treatment of their chronic pain, we hope to understand how the pain network responds to sensory stimuli and how DBS changes this response.

Eligibility Criteria

This trial is for adults aged 22-75 with chronic pain lasting over a year, severe (VAS score >6/10), and not responsive to medication or surgery. They must be able to give informed consent, have no cognitive impairments or conditions that increase surgical risk, and be capable of completing study tasks without significant psychological distress.

Inclusion Criteria

I have severe pain for over a year that doesn't improve with medication or surgery.

I have been approved for DBS surgery by a medical committee.

You are not displaying marked unease, agitation, or mental disquiet that may be exacerbated by outside influences or possible repercussions or from research documentation or activities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implantation of DBS leads within the sensory thalamus and periaqueductal gray, followed by electrophysiological recordings

8-12 weeks

Follow-up

Participants are monitored for long-term safety and effectiveness of DBS leads for chronic pain treatment

6 months

Treatment Details

Interventions

• Deep Brain Stimulation (DBS)

Trial Overview The study tests the safety and effects of deep brain stimulation (DBS) in the sensory thalamus and periaqueductal gray area for treating chronic pain. It involves implanting leads, recording brain activity in response to stimuli, and observing how DBS alters this activity.

Participant Groups

Group I: DBS for Chronic Pain Experimental Treatment 1 Intervention

Deep Brain Stimulation (DBS) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Deep Brain Stimulation for:

• Advanced Parkinson's disease
• Medically refractory tremor
• Dystonia
• Obsessive-compulsive disorder

Approved in European Union as Deep Brain Stimulation for:

• Parkinson's disease
• Essential tremor
• Dystonia
• Psychiatric conditions

Approved in Canada as Deep Brain Stimulation for:

• Parkinson's disease
• Essential tremor
• Dystonia

Who Is Running the Clinical Trial?

St. Joseph's Hospital and Medical Center, Phoenix

Lead Sponsor

Trials

69

Recruited

17,400+

Findings from Research

Deep brain stimulation (DBS) has been successfully used to treat chronic neuropathic pain in 113 patients over 13 years, particularly for conditions like pain after amputation and stroke, indicating its potential as a viable treatment option for refractory pain.

The study emphasizes the importance of somatotopic coverage during awake surgery and suggests that advancements in neuroimaging and neurophysiological assessments could improve patient selection and treatment outcomes, paving the way for larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropathic pain and deep brain stimulation. Pereira, EA., Aziz, TZ.[2021]

Deep brain stimulation (DBS) is an effective treatment for chronic pain that does not respond to other therapies, showing long-term positive outcomes in 50% to 80% of patients, depending on the type of pain and stimulation site.

The most successful results are observed in patients with deafferentation pain when stimulating the internal capsule and in those with somatic pain when using periventricular stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for the relief of chronic pain. Richardson, DE.[2011]

Deep brain stimulation (DBS) has been successfully used to treat chronic pain in 100 patients over 12 years, particularly for conditions like pain after amputation, stroke, and multiple sclerosis.

The technique emphasizes the importance of somatotopic coverage during awake surgery, and advancements in neuroimaging and neurophysiological insights may improve patient selection and treatment efficacy, suggesting a need for larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for pain. Pereira, EA., Green, AL., Aziz, TZ.[2013]

Deep brain stimulation (DBS) is an established treatment for movement disorders like Parkinson's disease and has been used for pain management since the 1950s, particularly for chronic pain syndromes resistant to other treatments.

Despite past challenges and mixed results in clinical trials, DBS remains a viable option for severe facial pain and other neuropathic pain conditions, with ongoing research aimed at improving patient selection and understanding its mechanisms of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation for Facial Pain. Singleton, WGB., Ashida, R., Patel, NK.[2021]

The incidence of intracranial bleeding during deep brain stimulation (DBS) surgery is relatively low at 2.5% per patient and 1.4% per implanted lead, indicating that while risks exist, they are infrequent.

Older patients (average 5 years older) are at a higher risk for intracranial bleeding during DBS surgery, and there is a nonsignificant trend suggesting that patients with hypertension may also be at increased risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial Bleeding in Deep Brain Stimulation Surgery: A Systematic Review and Meta-Analysis. Tiefenbach, J., Favi Bocca, L., Hogue, O., et al.[2023]

References

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

Neuropathic pain and deep brain stimulation. [2021]

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

Deep brain stimulation for the relief of chronic pain. [2011]

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

Treating Chronic Pain with Deep Brain Stimulation. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for pain. [2013]

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

Deep brain stimulation for the treatment of various chronic pain syndromes. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation for Facial Pain. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Intracranial Bleeding in Deep Brain Stimulation Surgery: A Systematic Review and Meta-Analysis. [2023]

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

Case Series: Deep Brain Stimulation for Facial Pain. [2021]