EMBRACE Tremor BiFUS
ConditionEssential Tremor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInSightec
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women with an age of 18 years or older (according to local labeling).
Willing to participate in the study (i.e., signed ICF). (Willing to be randomized).
Patient is able to undergo a high-resolution Computerized Tomography (CT) scan.
Patient is able to fit into MRI unit and comply with all contraindications for the specific magnetic resonance (MR) system including and limited to contrast medium should there be needed.
Disqualifiers
Subject experienced any non-transient neurological event or worsening following the previous Exablate procedure.
Patients with MRI related contraindications (e.g. presence of metallic implants incompatibility with MRI, severe claustrophobia, reaction to contrast medium).
Patients in whom it is not possible to avoid energy absorbing structures or sensitive tissues (e.g., skull implants, surgical clips, shunts, electrodes, dura patch, skull patch, electrodes, etc.) from the path of the ultrasound beam.
Patients with concurrent active infections disease and/or severe allergies with fever.
Trial design
Design model
Parallel
Treatments tested in this trial
Staged bilateral Exablate thalamotomy
Procedure/SurgeryStaged bilateral Exablate thalamotomy in ET patients
Local standard medical treatment after previous Exablate unilateral thalamotomy.
Other interventionLocal standard medical treatment
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Exablate ArmExperimental treatment 1 intervention
Group B: Control ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 MonthsSecondary outcomes
1
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 Months2
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 Months3
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 Months4
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 MonthsOther outcomes
1
Objective assessment of specific adverse events
Objective assessment of specific adverse events will be carried out for Speech, Gait and Motor Strength at baseline and 6 months and eventually at 12 months. If the adverse reported in the objective assessment is resolved at 6 months (Speech, Gait and Motor strength) it will not be carried out for the 12-month visit.
Time frame
6 Months, 12 Months2
Patient Global Impression of Change (PGIC)
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Patient Global Impression of Change (PGIC). PGIC is a 7-point scale depicting a patient's rating of overall improvement. Higher score means a worse condition.
Time frame
6 Months, 12 Months3
Clinician Global Impression of Change (CGIC)
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Clinician Global Impression of Change (CGIC). The CGIC comprises two companion one-item measures evaluating the following: (a) severity of pathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale. Higher score means a worse condition.
Time frame
6 Months, 12 Months4
Caregiver Global Impression of Change (CaGIC)
Between group comparison through month 6 and within group comparison vs baseline up to month 12 in Caregiver Global Impression of Change (CaGIC). The CaGIC comprises two companion one-item measures evaluating the following: (a) severity of pathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale. Higher score means a worse condition.
Time frame
6 Months, 12 Months Source ClinicalTrials.gov