Focused Ultrasound for Trigeminal Neuralgia
Recruiting in Palo Alto (17 mi)
Overseen byDheeraj Gandhi, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of Maryland, Baltimore
No Placebo Group
Approved in 5 Jurisdictions
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.
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.
12345What 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.
12356Is 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.
12378Eligibility 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
+8 more
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
+17 more
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: ExAblate Transcranial treatmentExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Maryland Medical CenterBaltimore, MD
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Who Is Running the Clinical Trial?
University of Maryland, BaltimoreLead Sponsor
InSightecIndustry Sponsor
Focused Ultrasound FoundationCollaborator
References
Transcranial magnetic resonance-guided focused ultrasound surgery for trigeminal neuralgia: a cadaveric and laboratory feasibility study. [2016]Transcranial MR-guided focused ultrasound surgery (MRgFUS) is evolving as a treatment modality in neurosurgery. Until now, the trigeminal nerve was believed to be beyond the treatment envelope of existing high-frequency transcranial MRgFUS systems. In this study, the authors explore the feasibility of targeting the trigeminal nerve in a cadaveric model with temperature assessments using computer simulations and an in vitro skull phantom model fitted with thermocouples.
The applicability and efficacy of magnetic resonance-guided high intensity focused ultrasound system in the treatment of primary trigeminal neuralgia. [2021]Primary trigeminal neuralgia is a common clinical refractory neuralgia characterized by an onset of excruciating pain that can severely affect patients' quality of life. Long-term suffering from this pain may lead to depression, anxiety, and suicide. Current treatments, however, are associated with high recurrent rates and severe complications. We hypothesize that both the applicability and efficacy of magnetic resonance-guided high intensity focused ultrasound (MR-HIFU) treatment in primary trigeminal neuralgia can be achieved under the following conditions: a specific target focus and incident channel, a temperature measurement system that does not incur damage to surrounding tissues, and an optimal radiation dose. Successful non-invasive treatment of primary trigeminal neuralgia by MR-HIFU systems could represent a breakthrough of this technology applied to the oral and maxillofacial region.
High-Frequency Ultrasound Ablation in Neurosurgery. [2023]Modern transcranial magnetic resonance-guided focused ultrasound is an incisionless, ablative treatment modality for a growing number of neurologic disorders. This procedure selectively destroys a targeted volume of cerebral tissue and relies on real-time MR thermography to monitor tissue temperatures. By focusing on a submillimeter target through a hemispheric phased array of transducers, ultrasound waves pass through the skull and avoid overheating and brain damage. High-intensity focused ultrasound techniques are increasingly used to create safe and effective stereotactic ablations for medication-refractory movement and other neurologic and psychiatric disorders.
Intracranial applications of magnetic resonance-guided focused ultrasound. [2021]The ability to focus acoustic energy through the intact skull on to targets millimeters in size represents an important milestone in the development of neurotherapeutics. Magnetic resonance-guided focused ultrasound (MRgFUS) is a novel, noninvasive method, which--under real-time imaging and thermographic guidance--can be used to generate focal intracranial thermal ablative lesions and disrupt the blood-brain barrier. An established treatment for bone metastases, uterine fibroids, and breast lesions, MRgFUS has now been proposed as an alternative to open neurosurgical procedures for a wide variety of indications. Studies investigating intracranial MRgFUS range from small animal preclinical experiments to large, late-phase randomized trials that span the clinical spectrum from movement disorders, to vascular, oncologic, and psychiatric applications. We review the principles of MRgFUS and its use for brain-based disorders, and outline future directions for this promising technology.
Innovative use of magnetic resonance imaging-guided focused ultrasound surgery for non-invasive breast cancer: a report of two cases. [2020]This report describes the first clinical experience with magnetic resonance imaging-guided focused ultrasound surgery (MRgFUS) using the ExAblate 2100 system for non-invasive breast cancer.
First noninvasive thermal ablation of a brain tumor with MR-guided focused ultrasound. [2020]Magnetic resonance-guided focused ultrasound surgery (MRgFUS) allows for precise thermal ablation of target tissues. While this emerging modality is increasingly used for the treatment of various types of extracranial soft tissue tumors, it has only recently been acknowledged as a modality for noninvasive neurosurgery. MRgFUS has been particularly successful for functional neurosurgery, whereas its clinical application for tumor neurosurgery has been delayed for various technical and procedural reasons. Here, we report the case of a 63-year-old patient presenting with a centrally located recurrent glioblastoma who was included in our ongoing clinical phase I study aimed at evaluating the feasibility and safety of transcranial MRgFUS for brain tumor ablation. Applying 25 high-power sonications under MR imaging guidance, partial tumor ablation could be achieved without provoking neurological deficits or other adverse effects in the patient. This proves, for the first time, the feasibility of using transcranial MR-guided focused ultrasound to safely ablate substantial volumes of brain tumor tissue.
Transcranial magnetic resonance imaging-guided focused ultrasound: noninvasive central lateral thalamotomy for chronic neuropathic pain. [2022]Recent technological developments open the field of therapeutic application of focused ultrasound to the brain through the intact cranium. The goal of this study was to apply the new transcranial magnetic resonance imaging-guided focused ultrasound (tcMRgFUS) technology to perform noninvasive central lateral thalamotomies (CLTs) as a treatment for chronic neuropathic pain.
High-intensity focused ultrasound for noninvasive functional neurosurgery. [2011]Transcranial magnetic resonance (MR)-guided high-intensity focused ultrasound (tcMRgHIFU) implies a novel, noninvasive treatment strategy for various brain diseases. Nine patients with chronic neuropathic pain were treated with selective medial thalamotomies. Precisely located thermal ablations of 4mm in diameter were produced at peak temperatures of 51 degrees C to 60 degrees C under continuous visual MR guidance and MR thermometry. The resulting lesions are clearly visible on follow-up MR imaging. All treatments were well tolerated, without side effects or neurological deficits. This is the first report on successful clinical application of tcMRgHIFU in functional brain disorders, portraying it as safe and reliable for noninvasive neurosurgical interventions.