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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores deep brain stimulation (DBS), a treatment using electrical signals to manage chronic pain. The goal is to assess the safety and effectiveness of DBS for individuals with severe, long-lasting pain persisting for over a year, unresponsive to medications or surgery. Participants will have DBS leads (tiny wires) placed in specific brain areas to evaluate their response to different sensations. Suitable candidates for this trial have intractable pain that hasn't improved with other treatments and can manage the required evaluations and tasks. As an unphased trial, this study offers the chance to contribute to groundbreaking research that could lead to new pain management solutions.

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 prior data suggests that deep brain stimulation is safe for treating chronic pain?

Research has shown that deep brain stimulation (DBS) has been safely used in many patients over the years, particularly for neurological issues when other treatments failed. For chronic pain, a small study confirmed that DBS is safe, whether used alone or with other brain stimulation methods. This study found that DBS is generally well-tolerated, with most participants experiencing no major issues.

While results vary with other types of brain stimulation, evidence suggests that DBS can be used safely. DBS has been around for a while and is frequently tested for safety in various conditions, making it a promising option for those considering it for chronic pain relief. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Deep Brain Stimulation (DBS) for chronic pain because it offers a novel approach by directly targeting the brain's pain centers. Unlike traditional treatments like medications or physical therapy, which often focus on managing symptoms, DBS involves implanting electrodes in the brain to modulate neural activity, potentially providing more precise and effective relief. This technique could offer hope for individuals who haven't found success with existing methods, as it has the potential to alter the brain's pain processing in a way that other treatments cannot.

What evidence suggests that deep brain stimulation is effective for chronic pain?

Research has shown that deep brain stimulation (DBS), which participants in this trial will receive, may help treat chronic pain. In some studies, patients experienced lasting pain relief after receiving DBS implants. These studies suggest that DBS can effectively manage chronic pain symptoms. However, not everyone benefits; some patients did not achieve the pain relief they hoped for. Overall, DBS has proven effective for some individuals in reducing chronic pain when other treatments have failed. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

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.

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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 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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6119957/

The Current State of Deep Brain Stimulation for Chronic Pain ... SCS delivered better pain outcomes at 6, 12, and 24 months follow up, with the percentage of patients reaching the target of 50% reduction at 24 months being ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06387914

Efficacy of Pain Intervention With Deep Brain Stimulation ... Only 2/11 had successful test stimulation, but the two who had DBS implanted reported ongoing pain relief.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923018949

Brain stimulation targets for chronic pain Noninvasive brain stimulation (NIBS) techniques have demonstrated their potential for chronic pain management, yet their efficacy exhibits variability ...

4. link.springer.com link.springer.com/article/10.1007/s10143-023-02032-1

Brain stimulation for chronic pain management: a narrative ... In other trials, about 30–40% of patients experienced successful outcomes of chronic pain treatment by MCS at several-year follow-up [75].

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10719838/

Deep brain stimulation for chronic pain: a systematic review ... Deep brain stimulation (DBS) has shown promise in effectively treating chronic pain. This study aimed to assess the efficacy of DBS in this context.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10227133/

Brain stimulation for chronic pain management: a narrative ... 76.2% of patients achieved treatment success after 53-month follow-up; only the patients with poststroke pain and peripheral neuropathic pain ...

7. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-025-01967-8

Safety and feasibility of deep brain stimulation of the anterior ... This pilot study confirmed the safety of anterior cingulate DBS alone or in combination with thalamic stimulation and suggested that it might ...