Recruiting

MRgFUS

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04279912

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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).

Conditions

Multiple Sclerosis

Study ID

NCT04279912

Start date

Jan 16, 2020

Status verified date

Feb, 2020

Completion date

Jul, 2021

Anticipated

Primary completion date

Mar, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Patients with Multiple Sclerosis and Tremor

Participants will undergo MRgFUS thermal ablation of the ventral intermedius (Vim) thalamus contralateral to the most affected side of the body.

Interventions

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

The intervention is MRIgFUS thermal ablation of the ventral intermedius (Vim) thalamus contralateral to the most affected side of the body.

Primary outcome measure

  • Composite safety outcome of MRgFUS thalamotomy [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Nadia Scantlebury, PhD

416-480-6100nadia.scantlebury@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Nadia Scatlebury, PhD

+1 416-480-6100nadia.scantlebury@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Feb 21, 2020

Last verified

Feb, 2020

Keywords

  • Tremor
  • Multiple Sclerosis
  • MR-guided Focused Ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2020-02-21.