MR-Guided Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Feb 19, 2020

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Male or Female aged 18-80 years
• • Willing and able to give consent and attend all study visits
• • A confirmed diagnosis of medication-refractory, MS-related hand tremor
• • No clinical evidence of relapse over 12 months or more before enrollment
• • No MRI activity over 3 months or more before enrollment
• • Presence of disabling postural or kinetic tremor
• • Unsatisfactory tremor response to adequate trials of at least two medications
• • Able to communicate sensations during the treatment
• • Stable doses of all medications for 30 days prior to and during study
• Exclusion Criteria:
• • Severe cerebellar dysfunction measured by Scale for the Assessment and Rating of Ataxia (\>35 out of 40)
• • Severe weakness or sensory loss in arm contralateral to the side of the brain considered for MRgFUS
• • Evidence of a superimposed or atypical movement disorder
• • Unstable cardiac status such as angina pectoris, congestive heart failure, etc.
• • Severe hypertension
• • Patients with standard contraindications for MR imaging
• • History of abnormal bleeding and/or coagulopathy
• • Ischemic or hemorrhagic stroke within 6 months
• • Symptoms and signs of increased intracranial pressure (e.g. headache, nausea, vomiting, lethargy, and papilledema)
• • Untreated, uncontrolled sleep apnea
• • Active or suspected acute or chronic uncontrolled infection
• • Receiving anticoagulant or antiplatelet therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage within one month of MRgFUS surgery
• • Not able or willing to tolerate the required prolonged stationary supine position during treatment
• • Participating or have participated in another clinical trial in the last 30 days
• • Unable to communicate with the investigator and staff
• • Presence of neurodegenerative disease or significant cognitive impairment
• • Presence of significant cognitive impairment (≤24 on MMSE)
• • Uncontrolled major psychiatric disorder or suicidal ideation
• • Risk factors for intraoperative or postoperative bleeding or documented coagulopathy
• • Presence of brain tumours
• • Any illness that in the investigator's opinion preclude participation in this study
• • Pregnancy or lactation
• • Legal incapacity or limited legal capacity
• • Deep Brain Stimulation or a prior stereotactic ablation of the basal ganglia
• • A history of seizures within the past year