This is a post-market (Phase IV) randomized, controlled, blinded, multicenter study with the aim to determine the added value of staged bilateral Exablate thalamotomy compared to a group of patients on previous unilateral treatment combined with local standard medical treatment.
In patients who have undergone previous unilateral Exablate thalamotomy for Essential Tremor, the aim of this trial is to determine the effect of staged bilateral Exablate thalamotomy compared to a group of patients on previous unilateral treatment. The effect will be measured on tremor reduction, functional impairment, disease-specific quality of life, adverse events and patient-perception of the overall treatment result in patients eligible for a staged bilateral Exablate procedure. Patients assigned to the treatment arm will receive staged bilateral Exablate thalamotomy. Patients assigned to control group will remain under local standard medical treatment. The primary efficacy study objective is to demonstrate that Exablate staged-bilateral thalamotomy treatment reduces tremor, as measured by Treated Upper Limb CRST (A+B) (0-28) score, to a higher extent than those remaining on previous unilateral Exablate thalamotomy at 6 months. The primary safety study objective is to assess the adverse events (AEs) of Exablate staged-bilateral thalamotomy treatment in comparison to those remaining on unilateral treatment (control group) plus medical treatment, including AE type, incidence, severity and duration at 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Staged bilateral Exablate thalamotomy in ET patients
Local standard medical treatment
Turku University Hospital
Turku, Finland
RECRUITINGUniversitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)
Kiel, Germany
Treated Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-28) score for the treated side.
The primary endpoint is the difference of the Treated Upper Limb CRST (A+B) score between groups at 6 months. Higher score means a worse tremor.
Time frame: 6 Months
Treated Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-28) score as assessed by the blinded reviewers of the video-recordings.
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Treated Upper Limb CRST (A+B) score as assessed by the blinded reviewers of the video-recordings. Higher score means a worse tremor.
Time frame: 6 Months, 12 Months
Clinical Rating Scale for Tremor (CRST) part A (0-76)
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in resting, postural, and action tremors of all items as measured by CRST part A. Higher score means a worse tremor.
Time frame: 6 Months, 12 Months
Bilateral Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-56)
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Bilateral Upper Limb CRST (A+B). Higher score means a worse tremor.
Time frame: 6 Months, 12 Months
Total Clinical Rating Scale for Tremor (CRST) (A+B) (0-116)
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Total CRST (A+B). Higher score means a worse tremor.
Time frame: 6 Months, 12 Months
Clinical Rating Scale for Tremor (CRST) part C (0-32)
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in functional disabilities as measured by CRST part C. Higher score means a worse tremor.
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Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
RECRUITINGCentral Japan International Medical Center
Minokamo, Gifu, Japan
NOT_YET_RECRUITINGKashiwaba Neurology Hospital
Sapporo, Hokkaido, Japan
NOT_YET_RECRUITINGMedical Research Institute KITANO HOSPITAL, PIIF Tazuke-Kofukai
Kita-ku, Osaka, Japan
NOT_YET_RECRUITINGGermans Trias i Pujol Hospital
Badalona, Spain
RECRUITINGHM CINAC- Hospital Universitario HM Puerta del Sur
Móstoles, Spain
RECRUITINGClinica Universidad de Navarra
Pamplona, Spain
RECRUITINGAscires Hospital_ECG Salud
Valencia, Spain
ACTIVE_NOT_RECRUITING...and 3 more locations
Time frame: 6 Months, 12 Months
Axial Clinical Rating Scale for Tremor (CRST) (0-20)
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Axial CRST defined as face, tongue, head tremor and voice items of CRST part A
Time frame: 6 Months, 12 Months
Quality of life questionnaire
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in disease specific QOL
Time frame: 6 Months, 12 Months
Change of tremor medication
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in tremor medication change
Time frame: 6 Months, 12 Months
Safety: Incidence and frequency of adverse events related to the treatment.
Incidence and frequency of adverse events related to the treatment and/or procedure. The investigator will capture any untoward events in the case report forms along with severity, duration, and resolution, and whether the event is considered serious. The severity of adverse events will be categorized according to the definition of adverse events from the International Organization for Standardization (ISO).
Time frame: 6 Months, 12 Months