Focused Ultrasound for Trigeminal Neuralgia

Overseen By Ranyah Almardawi, MBBS/MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must be taking: Anticonvulsants

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Severe psychiatric disorder, Pregnancy, Unstable cardiac status, Severe hypertension, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type of pain involving the face that can be disabling to those it affects.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, you cannot participate if you are on anticoagulant or antiplatelet medications.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, if you are taking anticoagulant or antiplatelet medications, you may not be eligible to participate.

What data supports the idea that Focused Ultrasound for Trigeminal Neuralgia is an effective treatment?

The available research shows that Focused Ultrasound, specifically magnetic resonance-guided high intensity focused ultrasound (MR-HIFU), is being explored as a promising treatment for trigeminal neuralgia. It is a non-invasive method that aims to target the trigeminal nerve without damaging surrounding tissues. This treatment could potentially be more effective than current options, which often have high recurrence rates and severe side effects. Although the research is still in early stages, the potential for a breakthrough in treating trigeminal neuralgia with this technology is significant. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment ExAblate Transcranial MR Guided Focused Ultrasound for trigeminal neuralgia?

Research suggests that magnetic resonance-guided focused ultrasound (MRgFUS) is a promising non-invasive treatment for various neurological conditions, including trigeminal neuralgia. It has been successfully used for other disorders by precisely targeting and heating specific brain areas without damaging surrounding tissues, which could potentially reduce pain and improve quality of life for patients with trigeminal neuralgia. ^{1 2 3 4 5}

What safety data exists for focused ultrasound treatment for trigeminal neuralgia?

The safety data for focused ultrasound treatment, including ExAblate systems, is primarily derived from studies on its use in neurosurgery and other conditions. The technology is incisionless and uses MR thermography to monitor tissue temperatures, minimizing the risk of overheating and brain damage. A feasibility study on trigeminal neuralgia using cadaveric models suggests potential for safe application. Additionally, MR-guided focused ultrasound has been used safely in other neurological and tumor ablations, with reports of successful procedures without adverse effects, indicating a promising safety profile. ^{1 2 3 5 6}

Is focused ultrasound treatment generally safe for humans?

Focused ultrasound treatment, used for various conditions, has been shown to safely target and destroy specific brain tissues without causing damage to surrounding areas. In a study on brain tumor ablation, it was successfully used without causing neurological deficits or other adverse effects. ^{1 2 3 5 6}

Is ExAblate Transcranial treatment a promising treatment for trigeminal neuralgia?

Yes, ExAblate Transcranial treatment is promising for trigeminal neuralgia because it is a noninvasive method that uses focused ultrasound to target and treat the affected nerve without surgery. It can help reduce pain effectively and improve the quality of life for patients who suffer from this condition. ^{1 2 3 7 8}

How is the ExAblate Transcranial treatment different from other treatments for trigeminal neuralgia?

The ExAblate Transcranial treatment is unique because it uses focused ultrasound waves guided by MRI to target and destroy specific brain tissue without any incisions, offering a non-invasive option for treating trigeminal neuralgia, unlike traditional surgical methods. ^{1 2 3 7 8}

Research Team

Dheeraj Gandhi, MD

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

This trial is for adults aged 21-75 with chronic, severe facial pain from Trigeminal Neuralgia that hasn't improved after standard treatments including anticonvulsants and possibly surgery. Candidates must be able to give consent, attend all visits, communicate during treatment, and have a feasible central lateral thalamotomy based on imaging.

Inclusion Criteria

Subjects who are able and willing to give consent and able to attend all study visits

I am between 22 and 74 years old.

Two members of the medical team have agreed upon inclusion and exclusion criteria

Exclusion Criteria

You are expected to live for less than a year.

Your skull density ratio is lower than 0.4 plus or minus 0.05.

Inability to provide informed consent, for example due to underlying cognitive impairment or aphasia

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ExAblate Transcranial focused ultrasound treatment targeting the central lateral thalamic nucleus

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person and/or virtual)

Treatment Details

Interventions

• ExAblate Transcranial treatment

Trial Overview The study tests the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) in treating Trigeminal Neuralgia. This non-invasive technique uses sound waves directed at the brain area responsible for the pain under MRI guidance.

Participant Groups

Group I: ExAblate Transcranial treatment Experimental Treatment 1 Intervention

The ExAblate Transcranial system will be used to destroy a small cluster of cells that may be causing the study participant's pain . The ExAblate uses ultrasound to heat a small spot in the brain called central lateral thalamic nucleus. Ultrasound passes through the skin and skull and into the brain to focus on this particular spot.

ExAblate Transcranial treatment is already approved in European Union, United States, Canada, Japan, China for the following indications:

Approved in European Union as ExAblate Neuro for:

• Essential Tremors
• Tremor Dominant Idiopathic Parkinson’s Disease
• Neuropathic Pain
• Metastatic Bone Cancer
• Uterine Fibroids

Approved in United States as ExAblate Neuro for:

• Medication-refractory Essential Tremor
• Tremor Dominant Parkinson Disease
• Advanced Parkinson Disease
• Pain Palliation of Metastatic Bone Cancer
• Ablation of Uterine Fibroid Tissue

Approved in Canada as ExAblate Neuro for:

• Pain Palliation of Metastatic Bone Cancer
• Treatment of Uterine Fibroids

Approved in Japan as ExAblate Neuro for:

• Pain Palliation of Metastatic Bone Cancer
• Treatment of Uterine Fibroids

Approved in China as ExAblate Neuro for:

• Pain Palliation of Metastatic Bone Cancer
• Treatment of Uterine Fibroids

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

InSightec

Industry Sponsor

Trials

92

Recruited

3,800+

Dr. Maurice R. Ferré

InSightec

Chief Executive Officer

MD

Dr. Arjun Desai

InSightec

Chief Medical Officer

MD

Focused Ultrasound Foundation

Collaborator

Trials

18

Recruited

460+

Findings from Research

Transcranial MR-guided focused ultrasound surgery (MRgFUS) successfully targeted the trigeminal nerve in a cadaveric model, achieving focal heating of up to 18°C without significant collateral damage to surrounding structures.

The study demonstrated that using no-pass regions through the petrous bone significantly reduced unwanted heating in adjacent areas, suggesting a promising approach for safe and effective treatment of trigeminal nerve conditions, although further in vivo studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic resonance-guided focused ultrasound surgery for trigeminal neuralgia: a cadaveric and laboratory feasibility study. Monteith, SJ., Medel, R., Kassell, NF., et al.[2016]

Magnetic resonance-guided high intensity focused ultrasound (MR-HIFU) has the potential to provide a non-invasive treatment for primary trigeminal neuralgia, which is known for causing severe pain and significantly impacting quality of life.

The effectiveness of MR-HIFU relies on precise targeting, careful temperature monitoring to protect surrounding tissues, and optimal radiation doses, suggesting that with the right conditions, it could be a safer alternative to current treatments that have high recurrence rates and complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The applicability and efficacy of magnetic resonance-guided high intensity focused ultrasound system in the treatment of primary trigeminal neuralgia. Ma, Y., Hsu, G., Zhang, F.[2021]

Modern transcranial magnetic resonance-guided focused ultrasound is a non-invasive treatment that effectively targets and destroys specific areas of brain tissue, making it a promising option for various neurological disorders.

This technique uses real-time MR thermography to ensure safety by monitoring tissue temperatures, allowing for precise ablation without damaging surrounding brain structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Frequency Ultrasound Ablation in Neurosurgery. Pomeraniec, J., Elias, WJ., Moosa, S.[2023]

Magnetic resonance-guided focused ultrasound (MRgFUS) is a noninvasive technique that can precisely target and treat brain disorders by creating thermal lesions and disrupting the blood-brain barrier, which is a significant advancement in neurotherapeutics.

MRgFUS has been successfully used in various clinical applications, including treating bone metastases and uterine fibroids, and is being explored as a safer alternative to traditional neurosurgery for a range of brain-related conditions, supported by studies from small animal models to large clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial applications of magnetic resonance-guided focused ultrasound. Lipsman, N., Mainprize, TG., Schwartz, ML., et al.[2021]

The first clinical experience with MRgFUS using the ExAblate 2100 system for non-invasive breast cancer showed promising results, with no severe adverse events reported in two patients.

Pathological examinations indicated that the treatment effectively induced tumor necrosis, suggesting that MRgFUS is a safe and feasible option for non-invasive breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative use of magnetic resonance imaging-guided focused ultrasound surgery for non-invasive breast cancer: a report of two cases. Matsutani, A., Ide, Y., Miura, S., et al.[2020]

A 63-year-old patient with a recurrent glioblastoma underwent transcranial MR-guided focused ultrasound surgery (MRgFUS), demonstrating the feasibility of this noninvasive technique for brain tumor ablation.

The procedure involved 25 high-power sonications and successfully achieved partial tumor ablation without causing neurological deficits or adverse effects, highlighting its safety and potential for treating brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First noninvasive thermal ablation of a brain tumor with MR-guided focused ultrasound. Coluccia, D., Fandino, J., Schwyzer, L., et al.[2020]

In a study involving 12 patients with chronic neuropathic pain, transcranial magnetic resonance imaging-guided focused ultrasound (tcMRgFUS) achieved significant pain relief, with a mean reduction of 49% at 3 months and 57% at 1 year after treatment.

The tcMRgFUS technique demonstrated high targeting precision and safety, with only one complication reported, and it offers a noninvasive alternative to traditional neurosurgery, minimizing risks such as infection and mechanical brain tissue damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic resonance imaging-guided focused ultrasound: noninvasive central lateral thalamotomy for chronic neuropathic pain. Jeanmonod, D., Werner, B., Morel, A., et al.[2022]

Transcranial magnetic resonance-guided high-intensity focused ultrasound (tcMRgHIFU) was successfully used to treat nine patients with chronic neuropathic pain through precise thermal ablations, demonstrating its potential as a noninvasive treatment for brain diseases.

The procedure was well tolerated by all patients, with no reported side effects or neurological deficits, highlighting the safety and reliability of tcMRgHIFU for neurosurgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity focused ultrasound for noninvasive functional neurosurgery. Martin, E., Jeanmonod, D., Morel, A., et al.[2011]

References

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

Transcranial magnetic resonance-guided focused ultrasound surgery for trigeminal neuralgia: a cadaveric and laboratory feasibility study. [2016]

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

The applicability and efficacy of magnetic resonance-guided high intensity focused ultrasound system in the treatment of primary trigeminal neuralgia. [2021]

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

High-Frequency Ultrasound Ablation in Neurosurgery. [2023]

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

Intracranial applications of magnetic resonance-guided focused ultrasound. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Innovative use of magnetic resonance imaging-guided focused ultrasound surgery for non-invasive breast cancer: a report of two cases. [2020]

6. England pubmed.ncbi.nlm.nih.gov

First noninvasive thermal ablation of a brain tumor with MR-guided focused ultrasound. [2020]

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

Transcranial magnetic resonance imaging-guided focused ultrasound: noninvasive central lateral thalamotomy for chronic neuropathic pain. [2022]

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

High-intensity focused ultrasound for noninvasive functional neurosurgery. [2011]