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Essential TremorBEST-FUSNCT04501484

Bilateral Essential Tremor Treatment With FUS

A study testing Magnetic Resonance-guided Focused Ultrasound VIM Thalamotomy in people with Essential Tremor, run by University Health Network, Toronto at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Essential Tremor
What is being tested?
Magnetic Resonance-guided Focused Ultrasound VIM Thalamotomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteCanada
Study dates
8 Jul 2020to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Toronto Western Hospital, University Health Network

    Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

Official title: Bilateral Essential Tremor Treatment With Magnetic Resonance-guided Focused Ultrasound

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.

Being tested
Magnetic Resonance-guided Focused Ultrasound VIM Thalamotomy
Keywords
High-Intensity Focused Ultrasound Ablation
Medical subject headings
Essential Tremor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic Resonance-guided Focused Ultrasound VIM ThalamotomyProcedure or surgery

    Ablation of contralateral VIM nucleus of thalamus with MRgFUS using ExAblate Neuro 4000 Device (InSightec Ltd, Tirat Carmel, Israel)

Study groups in NCT04501484
Study groupRoleWhat they receive
Treatment GroupExperimentalParticipants will undergo a thalamotomy contralateral to their previous treatment with MRgFUS using ExAblate Neuro 4000 device (InSightec Ltd, Tirat Carmel, Israel).
Receives: Procedure: Magnetic Resonance-guided Focused Ultrasound VIM Thalamotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in QUEST Score

    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

    Measured: 12 months

  2. Patient-based Assessment of Utility

    A patient-reported assessment of utility after 12 months using the question "Knowing what you know now, would you do this treatment again?".

    Measured: 12 months

Secondary outcomes (11)

  1. Gait Assessment (NRS-11)

    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)

    Measured: Immediately after surgery, post operative month 1, 3, 12, 24, 36

  2. Gait Assessment (missteps)

    Number of missteps in a 6 m standardized tandem walk

    Measured: Immediately after surgery, post operative month 1, 3, 12, 24, 36

  3. Falls

    Number of falls in last month

    Measured: Post operative month 1, 3, 12, 24, 36

  4. Speech Assessment (NRS-11)

    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)

    Measured: Immediately after surgery, post operative month 1, 3, 12, 24, 36

  5. Numbness

    Incidence of new-onset numbness

    Measured: Immediately after surgery, post operative month 1, 3, 12, 24, 36

  6. Dysgeusia

    Incidence of taste alterations

    Measured: Immediately after surgery, post operative month 1, 3, 12, 24, 36

  7. Other adverse events

    Incidence of other adverse events as classified in the CTCAE

    Measured: Immediately after surgery, post operative month 1, 3, 12, 24, 36

  8. Tremor (CRST)

    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).

    Measured: Immediately after surgery, post operative month 1, 3, 12, 24, 36

  9. Quality of life (QUEST)

    QUality of life in ESsential Tremor (QUEST) questionnaire (0-100%, higher scores correspond to a worse quality of life)

    Measured: Post operative month 1, 3, 12, 24, 36

  10. Quality of life (CRST part C)

    Part C of the Clinical Rating Scale for Tremor (CRST) (0-32, higher scores correspond to a worse quality of life)

    Measured: Post operative month 1, 3, 12, 24, 36

  11. Health Utility (EQ-5D-5L)

    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.

    Measured: Post operative month 1, 3, 12, 24, 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2020
  2. Study start8 Jul 2020
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04501484
Sponsor's protocol ID
20-5172
Acronym
BEST-FUS
Status last verified
May 2024
First submitted
29 Jul 2020
Last updated
8 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Magnetic Resonance-guided Focused Ultrasound VIM Thalamotomy in people with Essential Tremor, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in QUEST Score (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04501484.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.

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