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Bilateral Essential Tremor Treatment With FUS (BEST-FUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04501484
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : May 17, 2022
Sponsor:
Collaborator:
Université de Sherbrooke
Information provided by (Responsible Party):
Andres M. Lozano, University Health Network, Toronto

Study Description
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Brief Summary:

Combined Phase II/III, multi-center, prospective, single-blinded trial.

Ten (10) patients with who previously underwent successful and uncomplicated MRgFUS thalamotomy for essential tremor will undergo a contralateral treatment. The incidence of side effects will be determined at 1 and 3 months postoperatively, graded per the CTCAE v5 and analyzed by a data safety monitoring board. Upon successful review, this Phase II trial will be converted to a Phase III trial of utility that will enrol 40 additional patients. The primary outcome will be the change in QUEST score at 12 months postoperatively, as well as a patient-reported assessment of Health Utility. Secondary outcomes will include objective tremor, gait and speech assessments (filmed and scored by blinded evaluators), as well as quality of life questionnaires and adverse events questionnaires. Outcomes will be assessed immediately after the procedure, as well as 1, 3, 12, 24 and 36 months post-operatively.


Condition or disease Intervention/treatment Phase
Essential Tremor Procedure: Magnetic Resonance-guided Focused Ultrasound VIM Thalamotomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: All assessments filmed on video and scored by a blinded evaluator.
Primary Purpose: Treatment
Official Title: Bilateral Essential Tremor Treatment With Magnetic Resonance-guided Focused Ultrasound
Actual Study Start Date : July 8, 2020
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Group
Participants will undergo a thalamotomy contralateral to their previous treatment with MRgFUS using ExAblate Neuro 4000 device (InSightec Ltd, Tirat Carmel, Israel).
 Procedure: Magnetic Resonance-guided Focused Ultrasound VIM Thalamotomy
Ablation of contralateral VIM nucleus of thalamus with MRgFUS using ExAblate Neuro 4000 Device (InSightec Ltd, Tirat Carmel, Israel)


Outcome Measures
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Primary Outcome Measures :
  1. Change in QUEST Score [ Time Frame: 12 months ]
    Difference in QUEST score between baseline and the 12-month follow-up, with statistical significance defined as p = 0.05 and a minimum clinically important difference (MCID) defined as 5

  2. Patient-based Assessment of Utility [ Time Frame: 12 months ]
    A patient-reported assessment of utility after 12 months using the question "Knowing what you know now, would you do this treatment again?".


Secondary Outcome Measures :
  1. Gait Assessment (NRS-11) [ Time Frame: Immediately after surgery, post operative month 1, 3, 12, 24, 36 ]
    Patient-reported and blinded observer rating of the patient's ability to walk (Numerical rating scale (NRS-11) from 0 to 10, with 10 being best)

  2. Gait Assessment (missteps) [ Time Frame: Immediately after surgery, post operative month 1, 3, 12, 24, 36 ]
    Number of missteps in a 6 m standardized tandem walk

  3. Falls [ Time Frame: Post operative month 1, 3, 12, 24, 36 ]
    Number of falls in last month

  4. Speech Assessment (NRS-11) [ Time Frame: Immediately after surgery, post operative month 1, 3, 12, 24, 36 ]
    Patient-reported and blinded observer rating of the patient's ability to speak (Numerical rating scale (NRS-11) from 0 to 10, with 10 being best)

  5. Numbness [ Time Frame: Immediately after surgery, post operative month 1, 3, 12, 24, 36 ]
    Incidence of new-onset numbness

  6. Dysgeusia [ Time Frame: Immediately after surgery, post operative month 1, 3, 12, 24, 36 ]
    Incidence of taste alterations

  7. Other adverse events [ Time Frame: Immediately after surgery, post operative month 1, 3, 12, 24, 36 ]
    Incidence of other adverse events as classified in the CTCAE

  8. Tremor (CRST) [ Time Frame: Immediately after surgery, post operative month 1, 3, 12, 24, 36 ]
    Assessment of tremor using the Clinical Rating Scale for Tremor (CRST) parts A (0-88) and B (0-36), higher scores correspond to a worse tremor).

  9. Quality of life (QUEST) [ Time Frame: Post operative month 1, 3, 12, 24, 36 ]
    QUality of life in ESsential Tremor (QUEST) questionnaire (0-100%, higher scores correspond to a worse quality of life)

  10. Quality of life (CRST part C) [ Time Frame: Post operative month 1, 3, 12, 24, 36 ]
    Part C of the Clinical Rating Scale for Tremor (CRST) (0-32, higher scores correspond to a worse quality of life)

  11. Health Utility (EQ-5D-5L) [ Time Frame: Post operative month 1, 3, 12, 24, 36 ]
    Health Utility measured using the EQ-5D-5L and computed using the Canadian preference weights. Values range from 0 to 1, with 1 representing a perfect health.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be ≥ 18 years
  • The patient has a primary diagnosis of ET or ET plus confirmed by a movement disorder neurologist;
  • The patient previously underwent a MRgFUS (> 6 months ago);
  • The tremor on the untreated side negatively impacts the patients' quality of life;
  • The patient wants treatment of the contralateral side.

Exclusion Criteria:

  • Clinically relevant gait and/or balance impairment (e.g. wide-based, more than 2 falls/months, wheelchair, walker, cane use)
  • Clinically relevant speech impairment (e.g. impairment of intelligibility)
  • Inability to comply with the follow-up schedule;
  • Refusal of the treating physician.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04501484


Contacts
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Contact: Martha Lenis, BHA +14166035800 ext 2797 martha.lenis@uhnresearch.ca
Contact: Christian Iorio-Morin, MD, PhD christian.iorio-morin@usherbrooke.ca

Locations
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Canada, Ontario
Toronto Western Hospital, University Health Network Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Martha Lenis, BHA    +14166035800 ext 2797    martha.lenis@uhnresearch.ca   
Sponsors and Collaborators
University Health Network, Toronto
Université de Sherbrooke
Investigators
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Principal Investigator: Andres Lozano, MD, PhD University of Toronto
More Information
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Responsible Party: Andres M. Lozano, Neurosurgeon, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04501484    
Other Study ID Numbers: 20-5172
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Andres M. Lozano, University Health Network, Toronto:
High-Intensity Focused Ultrasound Ablation
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Movement Disorders
Central Nervous System Diseases