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
Qualifiers
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
Treatments tested in this trial
- Staged bilateral Exablate thalamotomy
- Local standard medical treatment after previous Exablate unilateral thalamotomy.
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov