12 Participants Needed

Deep Brain Stimulation for Chronic Pain

AS
PS
BS
CB
Overseen ByCatherine Borror
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.26789

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.67101112

Who Is on the Research Team?

EC

Edward Chang, M.D.

Principal Investigator

University of California, San Francisco

PS

Philip Starr, MD

Principal Investigator

University of California, San Francisco

PS

Prasad Shirvalkar, M.D., Ph.D

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.
See 8 more

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.
See 11 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Medtronic Summit RC+S
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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Active DBSActive Control1 Intervention
Group II: Inactive DBSPlacebo Group1 Intervention

Medtronic Summit RC+S is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Medtronic Summit RC+S for:
🇪🇺
Approved in European Union as Medtronic Summit RC+S for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Published Research Related to This Trial

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.
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.
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.
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]

Citations

Motor Cortex Stimulation for Deafferentation Pain. [2018]
Artifact Characterization and a Multipurpose Template-Based Offline Removal Solution for a Sensing-Enabled Deep Brain Stimulation Device. [2023]
Pain relief and functional recovery in patients with complex regional pain syndrome after motor cortex stimulation. [2011]
[Treatment of chronic pain with intracerebral stimulators]. [2006]
Reversibility of chronic neurologic deficits. Some effects of electrical stimulation of the thalamus and internal capsule in man. [2019]
Long term results of periventricular gray self-stimulation. [2019]
Deep brain stimulation for the relief of chronic pain. [2011]
Deep Brain Stimulation for Facial Pain. [2021]
Motor cortex stimulation for facial chronic neuropathic pain: A review of the literature. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Electrical stimulation of the brain in treatment of chronic pain. Experience over 5 years. [2011]
Deep brain stimulation for pain. [2013]
12.United Statespubmed.ncbi.nlm.nih.gov
Deep brain stimulation for control of intractable pain in humans, present and future: a ten-year follow-up. [2019]
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