DBS for Chronic Pain

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Antidepressants, Anti-seizure, Narcotics

Disqualifiers: Pregnancy, Dementia, Active depression, others

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

Compensation: Varies

Number of Visits: Unknown

4 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Deep brain stimulation (DBS) holds promise as a new option for patients suffering from treatment-resistant chronic pain, but current technology is unable to reliably achieve long-term pain symptom relief. A "one-size-fits-all" approach of continuous, 24/7 brain stimulation has helped patients with some movement disorders, but the key to reducing pain may be the activation of stimulation only when needed, as this may help keep the brain from adapting to stimulation effects. By expanding the technological capabilities of an investigative brain stimulation device, the investigators will enable the delivery of stimulation only when pain signals in the brain are high, and then test whether this more personalized stimulation leads to reliable symptom relief for chronic pain patients over extended periods of time.

Will I have to stop taking my current medications?

The trial requires that participants have stable doses of their current pain medications, so you will not need to stop taking them. However, if you are on Coumadin or platelet anti-aggregation therapy, you may need to discuss with your doctor about stopping these for surgery.

Is spinal cord stimulation safe for treating chronic pain?

Research shows that spinal cord stimulation (SCS) is generally safe for treating chronic pain. Studies report no device failures or unexpected adverse events, and complications are consistent with other SCS literature. Patients often find the devices easy to use, though some experience issues like failed recharges or interruptions. ^{1 2 3 4 5}

How does the treatment Medtronic Activa PC+S for chronic pain differ from other treatments?

The Medtronic Activa PC+S is a deep brain stimulation (DBS) device, which is unique because it involves implanting electrodes in specific brain areas to modulate pain signals, offering an option for chronic pain patients who have not found relief with other medical or surgical therapies. Unlike traditional pain medications, DBS targets the brain directly and can be adjusted to the patient's needs, providing a personalized approach to pain management. ^{6 7 8 9 10}

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

Deep brain stimulation (DBS) has shown success in treating chronic pain in selected patients, especially those with pain after amputation, stroke, or multiple sclerosis. Although DBS for pain fell out of favor due to past trial results, newer techniques and better patient selection have led to improved outcomes in some cases. ^{6 7 11 12 13}

Who Is on the Research Team?

Edward Chang, M.D.

Principal Investigator

University of California, San Francisco

Prasad Shirvalkar, M.D., Ph.D.

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Adults over 21 with severe chronic pain from conditions like post-stroke pain, spinal cord injury, or phantom limb pain that hasn't improved after trying several medications. They must be able to speak/read English and women should use contraception. Excluded are those with incompatible implants, cognitive impairments, recent substance abuse, major medical issues increasing surgery risk, or who can't stop certain blood thinners.

Inclusion Criteria

I have had severe pain for over a year that medicine hasn't helped.

I haven't improved with antidepressants, anti-seizure meds, or narcotics.

I experience severe pain after a stroke, spinal injury, or amputation.

Exclusion Criteria

I cannot stop taking blood thinners for surgery.

I need special treatments like ECT or TMS for a long-term condition.

I am an adult with chronic nerve pain that hasn't improved with treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biomarker Identification

Identify biomarkers of low and high pain states to define optimal neural signals for pain prediction

8-12 weeks

Closed-loop Algorithm Development

Develop closed-loop algorithms for DBS and test feasibility and efficacy in a single-blinded, sham controlled trial

6 months

Efficacy Assessment

Assess the efficacy of closed-loop DBS algorithms against traditional open-loop DBS and mechanisms of DBS tolerance

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Medtronic Activa PC+S

Trial Overview The trial is testing a new type of brain stimulation device for chronic pain relief. It compares continuous 'open-loop' DBS (current standard), no stimulation ('sham'), and 'closed-loop' DBS which activates only when the brain signals high pain levels. The goal is to see if this personalized approach provides better long-term relief.

How Is the Trial Designed?

Group I: Sham DBS Experimental Treatment 1 Intervention

Chronic brain recording and stimulation with unilateral or bilateral implantation in pain-related brain regions. Both thalamic pain syndrome and phantom pain participants will participate in sham, open-loop and closed-loop DBS, blinded to the participant. Open Loop involves tonic stimulation of ACC of OFC brain region. During closed-loop DBS sessions, stimulation will be delivered in response to identified personalized, brain biomarkers of chronic pain.Sham involves no active stimulation - brain recordings will remain active with no active stimulation. Because more than 6 sequences were used, only 1 "Arm/Group" is defined.

Group II: Open-Loop DBS and Closed-Loop DBS Experimental Treatment 2 Interventions

Chronic brain recording and stimulation with unilateral or bilateral implantation in pain-related brain regions. Both thalamic pain syndrome and phantom pain participants will participate in sham, open-loop and closed-loop DBS, blinded to the participant. Open Loop involves tonic stimulation of ACC of OFC brain region. During closed-loop DBS sessions, stimulation will be delivered in response to identified personalized, brain biomarkers of chronic pain.Sham involves no active stimulation - brain recordings will remain active with no active stimulation. Because more than 6 sequences were used, only 1 "Arm/Group" is defined.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Prasad Shirvalkar, MD, PhD

Lead Sponsor

Trials

1

Recruited

4+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

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 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]

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) and Motor Cortex stimulation (MCS) are effective methods for managing chronic pain, which is often complex and challenging to treat.

The review highlights that stimulation of specific brain areas, such as the thalamus and motor cortex, can provide partial pain relief in carefully selected patients, emphasizing the importance of targeted approaches in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation and Motor Cortex Stimulation for Chronic Pain. Senatus, P., Zurek, S., Deogaonkar, M.[2021]

Citations

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

Neuropathic pain and deep brain stimulation. [2021]

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

Treating Chronic Pain with Deep Brain Stimulation. [2023]

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

Deep Brain Stimulation for Facial Pain. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Current State of Deep Brain Stimulation for Chronic Pain and Its Context in Other Forms of Neuromodulation. [2020]

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

Treatment of chronic pain by deep brain stimulation: long term follow-up and review of the literature. [2019]

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

The performance and safety of an implantable spinal cord stimulation system in patients with chronic pain: a 5-year study. [2022]

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

Permanent Paddle-lead Trial for Spinal Cord Stimulation. [2020]

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

Efficacy and Safety of 10 kHz Spinal Cord Stimulation for the Treatment of Chronic Pain: A Systematic Review and Narrative Synthesis of Real-World Retrospective Studies. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

A single-center, open-label trial on convenience and complications of rechargeable implantable pulse generators for spinal cord stimulation: The Recharge Pain Trial. [2023]

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

Real World Characterization of Chronic Pain, Success Rates and Implant Rates: Evidence from a Digital Health Platform of Patients Undergoing Spinal Cord Stimulation Evaluations. [2023]

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 the treatment of various chronic pain syndromes. [2019]

13. India pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation and Motor Cortex Stimulation for Chronic Pain. [2021]