A Second Magnetic Resonance Guided Focused Ultrasound Thalamotomy for Essential Tremor

NCT04720469 | Completed DMC

• 1 other identifier: 3341
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be a single-centre, prospective, single-arm, open-label, 12-week pilot trial assessing the safety and preliminary efficacy of a second MR-guided focused ultrasound (MRgFUS) thalamotomy on the naïve brain hemisphere after 48 weeks or more of the first MRgFUS thalamotomy in patients with medication-refractory ET. This study will be conducted at the Focused Ultrasound Centre of Excellence at Sunnybrook Health Sciences Centre/University of Toronto.

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (1)

• Incidence at week 12 of new onset or significant worsening of: ataxic gait; speech impairment; cognitive impairment; contralateral weakness; patient-reported disabling sensory loss; Severe AEs related to the MRgFUS procedure.

  This composite outcome will be measured by the Scale for the Assessment and Rating of Ataxia (SARA) scale, neuropsychology battery, neurological examination and AE reports.

  12 weeks

Secondary Outcomes (2)

• Change in the tremor score (Part A and B) from baseline to 12 weeks after MRgFUS thalamotomy, adjusted for baseline scores.

  12 weeks

• Change in QUEST global score and EQ-5D from baseline to 12 weeks after MRgFUS, adjusted for baseline scores.

  12 weeks

Other Outcomes (2)

• Change in speech intelligibility and speaking rate from baseline to 12 weeks after MRgFUS thalamotomy, adjusted for baseline scores.

  12 weeks

• Change in the subscores of neuropsychological tests and self-reported questionnaires from baseline to 12 weeks after MRgFUS thalamotomy.

  12 weeks

Study Arms (1)

Patients with bilateral essential tremor who have undergone one MRgFUS thalamotomy

EXPERIMENTAL

Patients with bilateral essential tremor who have undergone one MRgFUS thalamotomy

Device: MRgFUS thalamotomy

Interventions

MRgFUS thalamotomy DEVICE

Ablation of untreated thalamus using focused ultrasound to abate tremor.

Also known as: ExAblate Neuro

Patients with bilateral essential tremor who have undergone one MRgFUS thalamotomy

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 22 years or older;
• Subjects who are able and willing to give consent and able to attend all study visits and MRgFUS procedure, understanding the associated risks, benefits, and alternative treatments;
• Diagnosis of ET as confirmed from clinical history and examination by a neurologist or neurosurgeon and unilateral MRgFUS thalamotomy at least 48 weeks prior;
• On a stable dose of medication for tremor for at least 4 weeks;
• Medication-refractory criterion: tremor refractory to adequate trials of at least two medications, one of which should be a first line therapy of either propranolol or primidone. An adequate medication trial is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated;
• Moderate-severe tremor severity criteria in the untreated hand: Despite medical treatment, untreated hand score of ≥2 points in the postural or intention component of the item 5 or 6 in the Part A of CRST, AND untreated hand score of ≥2 points in any one of the items 12-15 of the Part B of CRST;
• Disability criterion: ≥2 points in any one of the Part C items 17-23 as measured by the CRST;
• Able to communicate sensations during the MRgFUS treatment and to press the device STOP button.

You may not qualify if:

• Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc;
• Women who are pregnant;
• Gait subscore ≥2 points in the SARA scale;
• Speech subscore ≥2 points in the SARA scale;
• Patients with advanced kidney disease (with estimated glomerular filtration rate \<30 mL/min/1.73m2) or on dialysis;
• Patients with unstable cardiac status or severe hypertension including:
• Documented myocardial infarction within six months of enrollment
• Unstable angina on medication
• Unstable or worsening congestive heart failure
• Left ventricular ejection fraction below the lower limit of normal
• History of a hemodynamically unstable cardiac arrhythmia
• Cardiac pacemaker
• Severe hypertension (diastolic BP \> 100 on medication);
• Patients exhibiting any behaviour(s) or clinical assessment consistent with ethanol or substance abuse;
• Patients with history of abnormal bleeding, hemorrhage, and/or coagulopathy defined as abnormal coagulation profile (platelet \< 100,00/μl), PT (\>14 sec) or PTT (\>36 sec), and INR \> 1.3;

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Links

• Sunnybrook Focused Ultrasound Centre of Excellence

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Agessandro Abrahao, MD, MSc

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This study is open label. CRST rating will be performed by a trained neurologist who will be blinded to whether the CRST data were collected pre- or post- treatment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm, pre/post designl study

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: January 22, 2021
• Study Start: October 5, 2020
• Primary Completion: March 18, 2024
• Study Completion: March 18, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)