MR-Guided Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Device: Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis
- Registration Number
- NCT04279912
- Lead Sponsor
- Sunnybrook Health Sciences Centre
- 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 hand tremor in up to 12 patients with multiple sclerosis (relapsing-remitting, primary progressive or secondary progressive MS). This study will be conducted at the Focused Ultrasound Centre of Excellence and MS Clinic located at Sunnybrook Health Sciences Centre/ University of Toronto. Patients with stable MS and refractory hand tremor providing informed consent will receive MRgFUS thermal ablation of the Vim thalamus contralateral to the most affected side of the body (frequently this will be the dominant hand).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 6
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with Multiple Sclerosis and Tremor Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis Participants will undergo MRgFUS thermal ablation of the ventral intermedius (Vim) thalamus contralateral to the most affected side of the body.
- Primary Outcome Measures
Name Time Method Composite safety outcome of MRgFUS thalamotomy 90 days Composite outcome of detectable Vim lesion on MRI scan; AND lack of new-onset or worsening of contralateral upper limb sensory loss or weakness
- Secondary Outcome Measures
Name Time Method Changes from baseline in the EDSS (Expanded Disability Status Scale) scores 30 and 90 days Changes from baseline in the EDSS scores at 30 and 90 days. This is a scale to of quantify disability in multiple sclerosis. Score: 0 to 10 with higher scores meaning worse outcome.
Changes from baseline in QUEST (Quality of Life in Essential Tremor Questionnaire) scores 30 and 90 days Changes from baseline in QUEST scores at 30 and 90 days. This is a 30-item scale developed specifically for patients with essential tremor to measure items impacting perceived quality of life (QOL) that generic QOL measures do not effectively capture, including activities of daily living that are affected by tremor. Higher scores mean worse outcome.
Change from baseline in the CRST (Clinical Rating Scale for Tremors) 30 and 90 days Change from baseline in the treated upper limb tremor subscore of the CRST at 30 and 90 days. Score: 0 to 32 with higher scores meaning worse outcome.
Changes from baseline in the SARA (Scale for Assessment and Rating of Ataxia) scores 30 and 90 days Changes from baseline in the SARA scores at 30 and 90 days. This is a scale to of quantify function and disability related to ataxia. Score: 0 to 40 with higher scores meaning worse outcome.
Composite safety outcome of MRgFUS thalamotomy 30 days Composite outcome of detectable Vim lesion on MRI scan; AND lack of new-onset or worsening of contralateral upper limb sensory loss or weakness
Incidence and severity of adverse events related to MRgFUS thalamotomy 1, 7, 30, 90 and 120 days Incidence and severity of adverse events possibly, probably or definitely related to the MRgFUS procedure at 1, 7, 30, 90 and 120 days after treatment.
Changes from baseline in the speech intelligibility (percentage of intelligible words recorded during standardized passage reading) 30 and 90 days Changes from baseline in intelligibility percentage at 30 and 90 days. Score: 0 to 100% with higher scores meaning better outcome.
Incidence and severity of adverse events related to MS disease relapse or progression 30 and 90 days Incidence and severity of AEs possibly, probably or definitely-related to MS disease relapse or progression (based on clinical assessment) over 30 and 90 days.
Trial Locations
- Locations (1)
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada