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

NCT04279912 | Unknown DMC

• 1 other identifier: 029-2019
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

Tremor; Multiple Sclerosis; MR-guided Focused Ultrasound

Outcome Measures

Primary Outcomes (1)

• Composite safety outcome of MRgFUS thalamotomy

  Composite outcome of detectable Vim lesion on MRI scan; AND lack of new-onset or worsening of contralateral upper limb sensory loss or weakness

  90 days

Secondary Outcomes (8)

• Incidence and severity of adverse events related to MRgFUS thalamotomy

  1, 7, 30, 90 and 120 days

• Incidence and severity of adverse events related to MS disease relapse or progression

  30 and 90 days

• Changes from baseline in the EDSS (Expanded Disability Status Scale) scores

  30 and 90 days

• Changes from baseline in the SARA (Scale for Assessment and Rating of Ataxia) scores

  30 and 90 days

• Changes from baseline in the speech intelligibility (percentage of intelligible words recorded during standardized passage reading)

  30 and 90 days

Study Arms (1)

Patients with Multiple Sclerosis and Tremor

EXPERIMENTAL

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

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

Interventions

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

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

Patients with Multiple Sclerosis and Tremor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Multiple Sclerosis Society of Canada: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Tremor

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nir Lipsman, MD, PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Agessandro Abrahao, MD, MSc

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia Scantlebury, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon, Principal Investigator, Assistant Professor

Model Details: Single-centre, prospective, single-arm, open-label pilot trial assessing the feasibility and safety of MRgFUS thalamotomy for refractory hand tremor in up to 6 patients with multiple sclerosis

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 21, 2020
• Study Start: January 16, 2020
• Primary Completion: March 1, 2021
• Study Completion: July 1, 2021
• Last Updated: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)