MRI Guided Focused Ultrasound for Tremor in Multiple Sclerosis
MRI Guided Focused Ultrasound for Tremor in Multiple Sclerosis
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- MRI guided focused ultrasound thalamotomy
What it measured
Main measures
Device or procedure related adverse events reported
3 months
MRI lesionsSafety
Other measures (1)
Tremor rating scale
1 month
Physical function
Who could take part
MS (type not specified) · 18 to 90
Show the full criteria
Inclusion criteria
* Men and women, age 18 years and older * Patients who are able and willing to give informed consent and able to attend all study visits * Patients with a diagnosis of Multiple sclerosis (MS) as confirmed from clinical history and examination by a neurologist. * The patient must have disabling tremor from MS as indicated by a score of at least 2 on the Tremor Rating Scale (TRS) baseline global assessments by the examiner and the patient. Or Disabling is defined as significant impairment of the normal functions of daily life as indicated by a score of at least 5 on the Clinical Global Impression (CGI)-Severity scale.or ETRS * The MS patient must have disabling and medically refractory unilateral or bilateral upper extremity tremor. Patients with associated ipsilateral lower extremity tremor are not excluded. * The patient must have a history of an unsatisfactory response to medical management. Any patient will need to have tried and failed at least one drug. Alternatively, a patient may also qualify if tremor-suppressing medications are contraindicated due to a coexisting medical condition or drug allergy. * Patients should be on a stable dose of medications for 30 days prior to study entry
Exclusion criteria
* Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc. * Significant claustrophobia * Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment * Subjects with unstable cardiac status * Severe hypertension * Current medical condition resulting in abnormal bleeding and/or coagulopathy * Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within two weeks of focused ultrasound procedure or drugs known to increase risk or hemorrhage * History of intracranial hemorrhage * History of multiple strokes, or a stroke within past 6 months * Subjects with a history of seizures within the past year * Subjects with brain tumors * Are participating or have participated in another clinical trial in the last 30 days * More than mild non-tremor cerebellar dysfunction (ataxia, dysmetria, dysdiadokokinesia). * Cognitive dysfunction as evidenced by a score of less than ??? on the ???
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This project goal is to explore the option of (MRgFUS) as a treatment for tremor in MS patients with disabling refractory tremor.
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History
Started
Jan 2016
Main results due
Dec 2017
Finished
Dec 2018