Deep Brain Stimulation for Chronic Lower Back Pain

Recruiting at 1 trial location

Overseen By Wendy Sia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Blood thinners

Disqualifiers: Neurodegenerative conditions, Severe diabetes, 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

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with chronic lower back pain that hasn't improved with other treatments. It employs deep brain stimulation, where a small device sends signals to specific brain areas believed to control pain. The study targets the Subgenus Cingulate Cortex. Participants will be randomly assigned to receive either the actual stimulation or a placebo version to compare results. This study may suit those who have experienced severe back pain for over two years without relief from surgeries and other pain treatments. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for chronic pain sufferers.

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 not have an implanted spinal cord stimulator device and must be able to discontinue any existing therapeutic diathermy (a type of heat therapy).

What prior data suggests that this deep brain stimulation technique is safe for treating chronic lower back pain?

Research has shown that deep brain stimulation (DBS) targets the subgenual cingulate cortex in people with depression. In studies lasting over 8 years, many participants experienced significant and lasting symptom relief, suggesting that DBS might be safe for long-term use. Although these studies primarily focused on depression, they provide some evidence of the treatment's long-term safety.

No direct studies have examined DBS for chronic lower back pain, but research on depression offers some insights. The existing studies did not report major safety issues, suggesting that the treatment might be well-tolerated. However, safety can vary depending on the condition being treated. Participants should consider these factors when deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about deep brain stimulation (DBS) for chronic lower back pain because it offers a new approach by targeting the brain's subgenus cingulate cortex, unlike traditional treatments like medication, physical therapy, or surgery that focus on the spine or pain symptoms directly. This innovative technique aims to modulate brain activity related to pain perception, potentially providing relief for patients who haven't responded well to conventional methods. By offering a different mechanism of action, DBS could open the door to more effective pain management strategies for those with chronic lower back pain.

What evidence suggests that deep brain stimulation might be an effective treatment for chronic lower back pain?

Research has shown that deep brain stimulation (DBS) in a specific part of the brain may help reduce chronic low back pain. This trial will compare two groups: one receiving active DBS of the Subgenus Cingulate Cortex and another receiving sham stimulation. This brain area connects to both pain and mood, which often overlap in conditions like chronic pain and depression. Studies have found that DBS can help with various types of long-lasting pain, including pain after an amputation or a stroke. Early results suggest it might work by changing how the brain processes pain, offering relief for those whose pain hasn't improved with other treatments. Although more research is needed, the initial findings are promising for people with chronic low back pain that hasn't improved with other methods. ^{1 2 3 6 7}

Who Is on the Research Team?

Ausaf Bari, MD PhD

Principal Investigator

UCLA Department of Neurosurgery

Are You a Good Fit for This Trial?

This trial is for adults over 40 with severe chronic lower back pain that hasn't improved after surgery, physical therapy, spinal procedures, opioid or other pain medication trials. Candidates must have tried and not responded to spinal cord stimulation, be able to consent and follow up for 1.5 years, and live within 100 miles of UCLA. Exclusions include cognitive impairment, bleeding disorders, substance abuse issues in the last six months, uncontrolled medical conditions like heart disease or diabetes, pregnancy or planning to become pregnant.

Inclusion Criteria

I still have lower back pain despite having back surgery.

I have had severe back pain averaging over 8/10 for more than 2 years.

I did not get enough pain relief from spinal cord stimulation or I refused it.

Exclusion Criteria

Pregnant or planning to become pregnant

You cannot have MRIs or need to have MRIs often.

You have had an infection related to a previous medical implant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Open-label Period

Participants receive active stimulation to determine optimal settings

4 weeks

Randomized Double-blind Crossover

Participants undergo active or sham stimulation in a crossover design

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deep Brain Stimulation of the Subgenus Cingulate Cortex

Trial Overview The study tests deep brain stimulation (DBS) of the subgenual cingulate cortex as a treatment for chronic low back pain that doesn't respond to conventional therapies. It uses a randomized double-blind crossover design where neither participants nor researchers know who receives the real treatment until after the results are collected.

How Is the Trial Designed?

Group I: Active Stimulation Experimental Treatment 1 Intervention

Patients will be randomized in a 1:1 ratio to one of two groups: Active Treatment (active stimulation programmed to the settings found to be optimal during the initial open-label period) and a Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V).

Group II: Sham Stimulation Placebo Group 1 Intervention

Patients will be randomized in a 1:1 ratio to one of two groups: Active Treatment (active stimulation programmed to the settings found to be optimal during the initial open-label phase) and a Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V).

Deep Brain Stimulation of the Subgenus Cingulate Cortex is already approved in United States, Canada, European Union for the following indications:

Approved in United States as SCC DBS for:

• Treatment-resistant depression
• Obsessive-compulsive disorder

Approved in Canada as SCC DBS for:

• Treatment-resistant depression

Approved in European Union as SCC DBS for:

• Treatment-resistant depression

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

In a study of 45 patients with post-stroke pain, satisfactory pain control improved significantly with higher stimulation sites: 7% with spinal cord stimulation (SCS), 25% with deep brain stimulation (DBS), and 48% with motor cortex stimulation (MCS).

The study also found that painful sensations from stimulation were less frequent at higher stimulation sites, suggesting that targeting higher brain areas may reduce discomfort and improve pain management in post-stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor cortex stimulation for post-stroke pain: comparison of spinal cord and thalamic stimulation. Katayama, Y., Yamamoto, T., Kobayashi, K., et al.[2017]

In a study of 34 patients with intractable neuropathic pain, motor cortex electrical stimulation (MCS) within the central sulcus led to a pain reduction of 50% or more in 36% of patients after at least 12 months of follow-up.

Test stimulation showed that MCS within the central sulcus was more effective than stimulation on the precentral gyrus, indicating that targeting the central sulcus may be a favorable approach for pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation of primary motor cortex within the central sulcus for intractable neuropathic pain. Hosomi, K., Saitoh, Y., Kishima, H., et al.[2008]

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) 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]

Chronic low back pain (CLBP) is closely linked to depression, as both conditions share overlapping brain networks, particularly involving the subgenual cingulate cortex (SCC) and other emotional processing areas.

Deep brain stimulation (DBS) targeting the SCC may offer a novel treatment approach for CLBP by engaging the interconnected brain regions that mediate both pain and emotional responses, potentially leading to more effective therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation of the Subgenual Cingulate Cortex for the Treatment of Chronic Low Back Pain. Kashanian, A., Tsolaki, E., Pouratian, N., et al.[2022]

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]

Chronic neuropathic pain affects 3%-4.5% of the global population and is often inadequately treated by current medical therapies, leading to significant personal and social consequences.

Deep brain stimulation (DBS) targeting the dorsal anterior cingulate cortex (dACC) shows promise as a new treatment option for chronic neuropathic pain, supported by neurophysiological and clinical evidence, and suggests that further research is warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation of the dorsal anterior cingulate cortex for the treatment of chronic neuropathic pain. Russo, JF., Sheth, SA.[2015]

In a randomized controlled trial with 21 patients suffering from chronic low back pain, 10 sessions of active transcranial direct current stimulation (tDCS) significantly reduced pain interference, disability, and depression symptoms compared to sham treatment.

This study is the first to demonstrate the efficacy of targeting the left dorsal anterior cingulate cortex with tDCS to alleviate the affective components of chronic low back pain, suggesting a promising noninvasive treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation for Affective Symptoms and Functioning in Chronic Low Back Pain: A Pilot Double-Blinded, Randomized, Placebo-Controlled Trial. Mariano, TY., Burgess, FW., Bowker, M., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35125139/

Deep Brain Stimulation of the Subgenual Cingulate Cortex ... We provide a critical review of the literature that highlights the intersection in brain networks between chronic low back pain (CLBP) and depression.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04085406

DBS of the SCC for the Treatment of Medically Refractory ... The purpose of this study is to evaluate the feasibility and preliminary efficacy of deep brain stimulation of the subgenual cingulate cortex for the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715921069762

Deep Brain Stimulation of the Subgenual Cingulate Cortex ... We provide a critical review of the literature that highlights the intersection in brain networks between chronic low back pain (CLBP) and depression.

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

The Current State of Deep Brain Stimulation for Chronic Pain ... This article reviews the available data and professional opinion of the current state of DBS as a treatment for chronic pain, placing it in the context of other ...

5. withpower.com withpower.com/trial/phase-back-pain-3-2021-cc589

Deep Brain Stimulation for Chronic Lower Back Pain Deep Brain Stimulation (DBS) has shown success in treating chronic pain in selected patients, particularly those with pain after amputation, stroke, and other ...

6. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.2019.18121427

Long-Term Outcomes of Subcallosal Cingulate Deep Brain ... In >8 years of observation, most participants experienced a robust and sustained antidepressant response to SCC DBS.

7. mdpi.com mdpi.com/2077-0383/9/10/3260

A Decade of Progress in Deep Brain Stimulation of the ... This review aims to examine and consolidate clinical and preclinical research on the use of DBS as a treatment for depression, targeting the subcallosal ...