MR Guided Focused Ultrasound (FUS) for the Treatment of Trigeminal Neuralgia (NCT04579692) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
MR Guided Focused Ultrasound (FUS) for the Treatment of Trigeminal Neuralgia
United States10 participantsStarted 2021-08-16
Plain-language summary
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.
Who can participate
Age range21 Years – 75 Years
SexALL
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Inclusion criteria
✓. Clinical Diagnosis of Classical or Idiopathic TN refractory to medical therapy
✓. Age greater than 21 and less than 75 years
✓. Subjects who are able and willing to give consent and able to attend all study visits
✓. Documented chronic, severe pain for more than 6 months duration
✓. Failure to respond to the usual therapeutic regimen considered to be standard of care for Trigeminal Neuralgia. The patient should have failed a trial of at least two classes of therapeutic agents, including an anticonvulsant agent
✓. Patient with Trigeminal Neuralagia who has either failed a prior surgical approach considered to be standard of care for TN (Micro-vascular decompression, radiofrequency, stereotactic, Radiosurgery or glycerol) or is not considered to be an acceptable candidate for one of those alternative options (due to anesthesia risk, medical comorbidities or Patient refusal despite counseling).
✓. Central lateral thalamotomy is feasible based on evaluation of imaging studies
✓. Patient able to communicate sensations during the Exablate TcMRgFUS treatment
Exclusion criteria
✕. Severe psychiatric disorder such as uncontrolled depression, bipolar disorder, prior attempt at suicide or suicide ideation in preceding 12 months
✕. Life expectancy less than 12 months
✕
What they're measuring
1
Incidence of Treatment related adverse events
Timeframe: All events will be reported up to 6 months from treatment
. Anticoagulant or antiplatelet medications as well as underlying coagulopathy
✕. Prior or currently implanted thalamic DBS
✕. Pregnant ladies or women of childbearing age who are sexually active and not using contraception
✕. Inability to provide informed consent, for example due to underlying cognitive impairment or aphasia
✕. Presence of intracranial mass or an acute intracranial abnormality
✕. Subjects with unstable cardiac status such as Unstable angina pectoris, documented myocardial infarction within 6 months of protocol entry and ejection fraction less than 40