Status:
UNKNOWN
MR-Guided Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Multiple Sclerosis Society of Canada
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study will be a single-centre, prospective, single-arm, open-label pilot trial assessing the feasibility and safety of unilateral MR-guided focused ultrasound (MRgFUS) thalamotomy for refractory ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04279912
Start Date
January 16 2020
End Date
July 1 2021
Last Update
February 21 2020
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5