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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage severe facial pain in individuals with trigeminal neuralgia, particularly when linked to a specific brain lesion often associated with multiple sclerosis. The researchers aim to determine if deep brain stimulation, which involves implanting a device to send electrical signals to the brain, can control this pain when other treatments have failed. The trial seeks participants who have tried at least three different medications and two types of surgeries without success and have a specific brain lesion confirmed by MRI. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

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 prior data suggests that this technique is safe for treating trigeminal neuralgia?

Research has shown that deep brain stimulation (DBS) can safely treat long-lasting facial pain. Studies have found that DBS can reduce facial pain with few short-term complications.

Common issues include mild risks like infections or device-related problems, which are usually manageable. Specifically, some patients experienced such significant pain reduction that they required less additional pain treatment.

Overall, while DBS carries some risks, it has generally been well-tolerated by individuals with facial pain. For those considering joining a trial, it is a promising option to discuss with a doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for trigeminal neuralgia?

Unlike the standard treatments for trigeminal neuralgia, which often include medications like anticonvulsants or procedures like nerve blocks, deep brain stimulation (DBS) offers a different approach by directly targeting brain activity. DBS involves implanting a device that sends electrical impulses to specific brain areas, potentially providing relief by modulating pain signals at their source. Researchers are excited because this method could offer a new avenue for managing pain in patients who do not respond well to traditional treatments, potentially leading to more effective and long-lasting relief.

What evidence suggests that deep brain stimulation is effective for trigeminal neuralgia?

Research has shown that deep brain stimulation (DBS), which participants in this trial will receive, may help treat severe facial pain. Studies have found that DBS can greatly improve pain levels in people with persistent head and facial pain. In one study, DBS helped a patient reduce pain medication by half. Additionally, long-term results indicate that DBS remains effective for up to 83% of patients over six years. These findings suggest that DBS might provide relief for those with trigeminal neuralgia, especially when other treatments have failed. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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

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

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

Absolute contraindication to MRI

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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) 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]

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]

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) 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10046035/

Deep Brain Stimulation for Chronic Facial Pain Conclusively, our data demonstrate that DBS effectively suppressed facial pain with a relatively low complication rate in the short-term which ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1094715924004318

336449 Using Deep Brain Stimulation for Recalcitrant Pain ... The DBS implantation successfully alleviated the right facial pain. With up titration of stimulation setting, patient was able to decrease 50% of the total ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4121442/

Neuropathic Pain and Deep Brain Stimulation - PMC Only about 20 groups worldwide have reported long-term efficacy in up to 83 % of patients with follow-ups of up to 6 years (Table 1). In contrast, both other ...

4. withpower.com withpower.com/trial/phase-trigeminal-neuralgia-9-2022-01ae0

Deep Brain Stimulation for Trigeminal Neuralgia Deep brain stimulation (DBS) was found to significantly improve pain scores and quality of life in seven patients suffering from intractable head and facial ...

5. thejns.org thejns.org/focus/view/journals/neurosurg-focus/45/2/article-pE15.xml

Deep brain stimulation for intractable neuropathic facial pain in DBS of the VPM and PAG is a potential therapeutic option for patients suffering from severe, intractable facial pain refractory to other interventions.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39962366/

Safety and feasibility of deep brain stimulation of the ... This pilot study confirmed the safety of anterior cingulate DBS alone or in combination with thalamic stimulation and suggested that it might improve quality ...