Deep Brain Stimulation for Trigeminal Neuralgia

Overseen By Christian Iorio-Morin, MD, PhD, FRCS(C)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Université de Sherbrooke

Disqualifiers: Mri contraindication, Procedure contraindication

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: 1

Duration: Immediate post-surgery

6 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of this study is to assess the feasibility of deep brain stimulation for refractory trigeminal neuralgia due to a pontine lesion, as is usually seen in the context of multiple sclerosis. These patients usually have severe intractable facial pain and current medical and surgical options generally fail to achieve long lasting pain relief. Hoping to improve pain control in this population, the investigators of this trial propose a novel technique consisting of implanting a deep brain stimulation lead within the pontine lesion to modulate the generation of pain signals.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for patients with refractory trigeminal neuralgia who have failed at least three drugs, it is likely that you can continue your current medications.

What data supports the effectiveness of the treatment Deep Brain Stimulation for Trigeminal Neuralgia?

Deep Brain Stimulation (DBS) has shown promise in treating various types of intractable facial pain, including trigeminal neuralgia, by improving pain scores and quality of life in some patients. Although results can vary, DBS has been effective for chronic pain conditions that do not respond to other treatments. ^{1 2 3 4 5}

Is deep brain stimulation generally safe for humans?

Deep brain stimulation (DBS) is generally considered a safe procedure, but it can have complications. Common issues include infections, device malfunctions, and the need for additional surgeries. While serious problems are rare, it's important to be aware of these potential risks. ^{6 7 8 9 10}

How is deep brain stimulation treatment different from other treatments for trigeminal neuralgia?

Deep brain stimulation (DBS) is unique because it involves surgically implanting electrodes to modulate brain activity, which is different from medications or less invasive procedures. It is often considered a last resort for patients whose pain does not respond to standard treatments, offering a novel approach by targeting specific brain areas to alleviate chronic pain. ^{1 2 5 11 12}

Eligibility Criteria

This trial is for adults over 18 with severe facial pain from trigeminal neuralgia that hasn't improved after trying at least three medications and one surgery. They must have an MRI showing a demyelinating lesion in the brainstem touching the trigeminal nerve.

Inclusion Criteria

I am 18 years old or older.

My facial pain hasn't improved despite trying 3 drugs and 2 surgeries.

My MRI shows a lesion in the brainstem touching the trigeminal nerve.

Exclusion Criteria

Absolute contraindication to MRI

I have a health condition that makes the procedure unsafe for me.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implantation of deep brain stimulation lead within the pontine lesion

Immediate post-surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular visits (in-person and virtual)

Treatment Details

Interventions

• Deep brain stimulation

Trial Overview The study tests deep brain stimulation (DBS) as a new method to relieve intense facial pain caused by trigeminal neuralgia with a pontine lesion, often seen in multiple sclerosis patients where other treatments failed.

Participant Groups

Group I: Deep brain stimulation Experimental Treatment 1 Intervention

Implantation of deep brain stimulation lead within the pontine lesion

Deep brain stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Deep Brain Stimulation for:

• Parkinson's disease
• Essential tremor
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Trigeminal neuralgia

Approved in European Union as Deep Brain Stimulation for:

• Parkinson's disease
• Essential tremor
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Trigeminal neuralgia

Approved in Canada as Deep Brain Stimulation for:

• Parkinson's disease
• Essential tremor
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Trigeminal neuralgia

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Findings from Research

A novel surgical approach using deep brain stimulation (DBS) targeting both the sensory thalamus and motor cortex resulted in near complete resolution of facial pain in a patient with trigeminal deafferentation pain syndrome (TDPS) within less than a year, demonstrating its efficacy.

Functional MRI (fMRI) was effectively utilized to guide the placement of DBS electrodes, highlighting its potential as a valuable tool in the surgical management of complex pain disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional MRI-Guided Motor Cortex and Deep Brain Stimulation for Intractable Facial Pain: A Novel, Personalized Approach in 1 Patient. Saway, BF., Webb, T., Weber, A., et al.[2023]

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) was found to significantly improve pain scores and quality of life in seven patients suffering from intractable head and facial pains after electrode insertion in specific brain regions.

While there was considerable variability in individual patient outcomes, the overall results suggest that DBS can be an effective treatment option for managing severe pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for neuropathic cephalalgia. Green, AL., Owen, SL., Davies, P., et al.[2008]

Deep brain stimulation (DBS) of the posterior hypothalamus significantly reduced pain in patients with chronic cluster headaches, with a remarkable increase in pain-free days from 1-2% to 71% over five years.

While DBS was effective for chronic cluster headaches and one case of SUNCT, it was unsuccessful in treating atypical facial pain in three patients, highlighting the need for tailored approaches in headache management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on neurosurgical treatment of chronic trigeminal autonomic cephalalgias and atypical facial pain with deep brain stimulation of posterior hypothalamus: results and comments. Broggi, G., Franzini, A., Leone, M., et al.[2019]

Carbamazepine and lamotrigine are the most effective medications for treating trigeminal neuralgia, with baclofen also showing some effectiveness, highlighting the need for effective treatments with manageable side effects.

While drug therapy helps most patients, some may need additional nonpharmacological treatments, and future approaches like neuromodulation could offer new options for managing this chronic pain syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug therapy of trigeminal neuralgia. Canavero, S., Bonicalzi, V.[2006]

Deep brain stimulation (DBS) therapy is effective for treating movement disorders and neuropathic pain, but it carries risks of adverse events related to the implanted hardware.

In two reported cases, patients experienced sudden loss of DBS effectiveness due to battery failure, necessitating emergency hospital admission and re-implantation of the pulse generator, highlighting the importance of monitoring device functionality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure of chronic pallidal stimulation in dystonic patients is a medical emergency. Yianni, J., Nandi, D., Ch, M., et al.[2022]

Deep brain stimulation (DBS) for Parkinson's disease is generally safe, with a low mortality rate of 0.2% and permanent morbidity at 0.6%, but complications such as intracerebral hemorrhage (ICH) and seizures can occur in a small percentage of cases.

The study found that the type of lead used in DBS can influence complications, with Medtronic's leads associated with higher rates of perielectrode brain edema compared to Boston Scientific's, highlighting the need for further research on hardware design to improve safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. Servello, D., Galbiati, TF., Iess, G., et al.[2023]

A review of 221 unique adverse events related to deep brain stimulation (DBS) devices for Parkinson's disease revealed that the most common complications were infections (16.2%) and lead migrations (8.6%).

Over 40% of the reported adverse events required patients to return to the operating room for device explantation or revision, highlighting the need for further research to improve the safety and reliability of DBS systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. Bennett, J., MacGuire, J., Novakovic, E., et al.[2023]

In a study of 123 patients undergoing deep brain stimulation (DBS) surgery, adverse events (AEs) occurred in 14.6% of cases, but all resolved without permanent effects, indicating a relatively safe profile for the procedure.

The study found that rates of complications such as infections and lead revisions were comparable to existing literature, suggesting that the proposed categories for assessing AEs are effective for evaluating DBS safety and can help in benchmarking against other studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards unambiguous reporting of complications related to deep brain stimulation surgery: A retrospective single-center analysis and systematic review of the literature. Engel, K., Huckhagel, T., Gulberti, A., et al.[2019]

Deep brain stimulation (DBS) is highly effective for treating movement disorders like Parkinson's disease and has also been used successfully for conditions such as intractable epilepsy and chronic pain.

The procedure for implanting a DBS device is considered relatively safe, with low risks of major complications or permanent neurological deficits, but awareness of potential complications and preventive measures is crucial for ensuring patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of Deep Brain Stimulation for Movement Disorders: Literature Review and Personal Experience. Shashkin, C.[2023]

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]

Trigeminal branch stimulation is a safe and minimally invasive peripheral nerve stimulation technique used to treat various craniofacial pain disorders, including trigeminal neuralgia and migraines.

This method can be used alone or in combination with other nerve stimulation therapies, making it a versatile option for managing complex pain conditions that do not respond to traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral Nerve Stimulation for Facial Pain Using Conventional Devices: Indications and Results. Winfree, CJ.[2021]

References

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

Functional MRI-Guided Motor Cortex and Deep Brain Stimulation for Intractable Facial Pain: A Novel, Personalized Approach in 1 Patient. [2023]

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

Deep Brain Stimulation for Facial Pain. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for neuropathic cephalalgia. [2008]

4. Italy pubmed.ncbi.nlm.nih.gov

Update on neurosurgical treatment of chronic trigeminal autonomic cephalalgias and atypical facial pain with deep brain stimulation of posterior hypothalamus: results and comments. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Drug therapy of trigeminal neuralgia. [2006]

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

Failure of chronic pallidal stimulation in dystonic patients is a medical emergency. [2022]

7. Austria pubmed.ncbi.nlm.nih.gov

Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. [2023]

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

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. [2023]

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

Towards unambiguous reporting of complications related to deep brain stimulation surgery: A retrospective single-center analysis and systematic review of the literature. [2019]

10. Austria pubmed.ncbi.nlm.nih.gov

Complications of Deep Brain Stimulation for Movement Disorders: Literature Review and Personal Experience. [2023]

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

Neuropathic pain and deep brain stimulation. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Peripheral Nerve Stimulation for Facial Pain Using Conventional Devices: Indications and Results. [2021]