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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the feasibility and preliminary efficacy of deep brain stimulation of the subgenual cingulate cortex for the treatment of chronic medically-refractory low back pain using a randomized double-blind crossover design.

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 data supports the effectiveness of the treatment 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 conditions. The subgenual cingulate cortex (SCC) is connected to brain areas involved in both chronic pain and depression, suggesting that DBS targeting this area could be effective for chronic lower back pain. ^{1 2 3 4 5}

Is deep brain stimulation generally safe for humans?

Deep brain stimulation (DBS) has been shown to be safe in humans for treating movement disorders and chronic pain, with successful outcomes reported in selected patients over the past decade. Studies have been conducted in experienced centers, and while more research is needed, the existing data supports its safety in humans. ^{1 2 6 7 8}

How is the treatment of Deep Brain Stimulation for Chronic Lower Back Pain different from other treatments?

Deep Brain Stimulation (DBS) for chronic lower back pain is unique because it targets the subgenual cingulate cortex, a brain area linked to both pain and depression, offering a novel approach by addressing the overlap between these conditions, unlike traditional pain treatments that may not consider this connection. ^{1 2 3 5 6}

Research Team

Ausaf Bari, MD PhD

Principal Investigator

UCLA Department of Neurosurgery

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

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

Deep Brain Stimulation of the Subgenual Cingulate Cortex for the Treatment of Chronic Low Back Pain. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for pain. [2013]

3. India pubmed.ncbi.nlm.nih.gov

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

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

Motor cortex stimulation for post-stroke pain: comparison of spinal cord and thalamic stimulation. [2017]

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

Neuropathic pain and deep brain stimulation. [2021]

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

Deep brain stimulation of the dorsal anterior cingulate cortex for the treatment of chronic neuropathic pain. [2015]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Electrical stimulation of primary motor cortex within the central sulcus for intractable neuropathic pain. [2008]

8. England 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. [2021]