Deep Brain Stimulation for Chronic Pain

Overseen by Philip Starr, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Francisco

Disqualifiers: Uncontrolled hypertension, Severe diabetes, Active depression, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests a new type of brain stimulation device for people with chronic pain that doesn't respond to other treatments. The device sends electrical signals to different parts of the brain and adjusts these signals based on real-time pain levels. The goal is to provide better and longer-lasting pain relief.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should have stable doses of medications for 30 days prior to the baseline visit, which suggests you may need to maintain your current medication regimen.

What data supports the effectiveness of the treatment Medtronic Summit RC+S, Medtronic Activa PC+S, Medtronic Summit RC+S, Percept RC for chronic pain?

Research shows that deep brain stimulation (DBS) using Medtronic devices can help reduce chronic pain. In one study, patients experienced pain relief lasting up to seven hours with DBS, and another study showed improvements in pain and other symptoms in patients with complex regional pain syndrome. ^{1 2 3 4 5}

Is deep brain stimulation generally safe for treating chronic pain?

Deep brain stimulation (DBS) for chronic pain has been shown to be generally safe, with few side effects and no reports of worsening pain. Studies have reported acceptable complication rates and rare serious issues, with many patients experiencing significant pain relief. ^{6 7 8 9 10}

What makes the Medtronic Summit RC+S treatment unique for chronic pain?

The Medtronic Summit RC+S is unique because it is the first FDA-approved deep brain stimulation device with sensing capabilities, allowing it to record brain signals during active stimulation. This feature may help tailor the treatment to individual patients' needs, potentially improving its effectiveness for chronic pain management. ^{2 5 7 11 12}

Research Team

Prasad Shirvalkar, M.D., Ph.D

Principal Investigator

University of California, San Francisco

Edward Chang, M.D.

Principal Investigator

University of California, San Francisco

Philip Starr, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults aged 22-80 with severe, treatment-resistant chronic pain from conditions like post-traumatic or postsurgical syndromes, nerve injuries, and more. Participants must have had this pain for over two years, failed at least two different pain medications, and not have a correctible cause for the pain. They should be able to understand English and consent to the study. Pregnant women or those with certain medical devices or major health issues can't join.

Inclusion Criteria

My pain level changes by 3 or more points.

You have to score 25 or more on a test called the Montreal Cognitive Assessment (MoCA) to show that your memory and thinking abilities are at a certain level.

I have tried at least two different pain medications for a month without relief.

Exclusion Criteria

I have had brain surgery to remove a tumor.

I cannot stop my blood thinners for surgery and recovery.

I had deep brain stimulation surgery with a system not compatible with RC+S.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Trial Period

Subjects undergo bilateral surgical implant of temporary electrodes to identify candidate biomarkers of pain and optimal stimulation parameters

4 weeks

Inpatient stay

Chronic Implantation and Closed-loop DBS Testing

Subgroup of patients receive chronic implantation for long-term recording and stimulation, testing closed-loop DBS algorithms

2 years

Weekly blocks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• Medtronic Summit RC+S (Deep Brain Stimulation)

Trial Overview The trial tests a new Deep Brain Stimulation (DBS) device called Medtronic Summit RC+S designed to adaptively target multiple brain regions related to chronic pain. Unlike traditional DBS that stimulates continuously which may lose effect over time, this technology aims for lasting relief by adjusting stimulation as needed.

Participant Groups

Group I: Active DBS Active Control 1 Intervention

Chronic brain recordings and stimulation with bilateral implantations in pain-related brain regions. All participants will participate in active DBS, blinded to the participant.

Group II: Inactive DBS Placebo Group 1 Intervention

Non-active chronic brain stimulation in pain-related brain regions. brain recordings will remain active during this period. All participants will participate in inactive DBS, blinded to the participant.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Jordan Gladman

National Institute of Neurological Disorders and Stroke (NINDS)

Chief Medical Officer

MD from Harvard Medical School

Walter J. Koroshetz

National Institute of Neurological Disorders and Stroke (NINDS)

Chief Executive Officer since 2007

MD from the University of Chicago

Findings from Research

Motor cortex stimulation (MCS) has been shown to effectively relieve deafferentation pain in 40-64% of patients, although its effectiveness may decrease over time, which can be managed by adjusting stimulation settings.

Recent advancements in non-invasive techniques like repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) are providing new alternatives for pain management and helping to identify patients who are likely to respond to MCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor Cortex Stimulation for Deafferentation Pain. Hussein, AE., Esfahani, DR., Moisak, GI., et al.[2018]

The Medtronic 'Percept' device, the first FDA-approved deep brain stimulation system with sensing capabilities, was tested on 7 subjects to identify and mitigate artifacts in local field potential signals that could affect its performance.

Using automated template subtraction techniques, researchers successfully removed various artifacts, such as ECG signals and nonphysiologic noise, which could otherwise distort the neural signals and impact the effectiveness of adaptive deep brain stimulation algorithms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artifact Characterization and a Multipurpose Template-Based Offline Removal Solution for a Sensing-Enabled Deep Brain Stimulation Device. Hammer, LH., Kochanski, RB., Starr, PA., et al.[2023]

Motor cortex stimulation (MCS) in two patients with complex regional pain syndrome (CRPS) not only provided significant pain relief (60-70% reduction in pain scores) but also improved sensory and motor functions, which is a notable advantage over traditional spinal cord stimulation.

Long-term benefits were observed, including increased joint range of motion and reduced symptoms like allodynia and hyperpathia, suggesting that MCS may positively affect brain regions involved in pain processing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain relief and functional recovery in patients with complex regional pain syndrome after motor cortex stimulation. Fonoff, ET., Hamani, C., Ciampi de Andrade, D., et al.[2011]

A new cerebral stimulation technique for chronic pain was tested on nine patients, where a small electrode was implanted to allow patients to control their pain relief using a portable stimulator.

The method effectively suppressed pain for up to seven hours with minimal complications, making it a safer and reversible alternative to traditional coagulation methods for treating chronic intractable pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of chronic pain with intracerebral stimulators]. Mundinger, F.[2006]

Deep brain stimulation of the thalamus and internal capsule significantly improved various conditions including pain, hemiparesis, dystonia, tremor, speech impairment, and epilepsy.

Effective stimulation requires precise voltage settings (around 6 V) and timing, as deviations from these parameters can lead to a loss of clinical benefits, highlighting the importance of accurate 'biocalibration' for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reversibility of chronic neurologic deficits. Some effects of electrical stimulation of the thalamus and internal capsule in man. Cooper, IS., Upton, AR., Amin, I.[2019]

Out of 30 patients who received self-stimulating devices for pain control, 66% (18 patients) experienced significant pain relief, indicating a successful outcome for the majority of those implanted.

The stimulation was effective for brief periods (5 to 30 minutes every 2 to 12 hours) and was associated with minimal side effects and a low complication rate, suggesting it is a safe option for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term results of periventricular gray self-stimulation. Richardson, DE., Akil, H.[2019]

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]

Motor cortex stimulation (MCS) has been shown to be a safe and effective treatment for facial chronic neuropathic pain (FCNP), with 84% of patients achieving good pain control after permanent implantation of the system.

A total of 118 patients were reviewed, but the evidence is still limited due to the need for larger randomized controlled studies to establish MCS as a standard treatment for FCNP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor cortex stimulation for facial chronic neuropathic pain: A review of the literature. Monsalve, GA.[2021]

In a study of 48 patients with chronic pain, 72% experienced complete or partial pain relief after undergoing electrical stimulation of the brain, demonstrating its efficacy as a treatment option.

The procedure was found to be safe, with no reported mortality or permanent complications, and 59% of patients were able to stop using narcotics, indicating a significant improvement in their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation of the brain in treatment of chronic pain. Experience over 5 years. Young, RF., Kroening, R., Fulton, W., et al.[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]

In a study of 48 patients with chronic pain, deep brain stimulation achieved long-term pain control in 63% of cases, with follow-up periods ranging from 6 months to 10 years.

While there is an initial decline in pain control within the first 2 years due to tolerance, results stabilize afterward, indicating that deep brain stimulation can be a safe and effective option for selected patients, particularly those with failed-back syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for control of intractable pain in humans, present and future: a ten-year follow-up. Kumar, K., Wyant, GM., Nath, R.[2019]

References

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

Motor Cortex Stimulation for Deafferentation Pain. [2018]

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

Artifact Characterization and a Multipurpose Template-Based Offline Removal Solution for a Sensing-Enabled Deep Brain Stimulation Device. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Pain relief and functional recovery in patients with complex regional pain syndrome after motor cortex stimulation. [2011]

4. Germany pubmed.ncbi.nlm.nih.gov

[Treatment of chronic pain with intracerebral stimulators]. [2006]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Reversibility of chronic neurologic deficits. Some effects of electrical stimulation of the thalamus and internal capsule in man. [2019]

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

Long term results of periventricular gray self-stimulation. [2019]

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

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation for Facial Pain. [2021]

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

Motor cortex stimulation for facial chronic neuropathic pain: A review of the literature. [2021]

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

Electrical stimulation of the brain in treatment of chronic pain. Experience over 5 years. [2011]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for pain. [2013]

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

Deep brain stimulation for control of intractable pain in humans, present and future: a ten-year follow-up. [2019]