Actively Recruiting
EMBRACE Tremor BiFUS
Led by InSightec · Updated on 2026-05-08
100
Participants Needed
8
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EMBRACE Tremor BiFUS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women with an age of 18 years or older.
- Willing to participate in the study and sign informed consent.
- Able to undergo a high-resolution CT scan.
- Able to fit into MRI unit and meet MRI safety requirements.
- Thalamus, sub-thalamus, and pallidum visible on MRI imaging.
- Able to communicate sensations during the procedure without general anesthesia.
- Able to use the Stop Sonication button freely.
- Willing to have their head shaved prior to treatment.
- No history of claustrophobia unresponsive to medications.
- Eligible for second side staged bilateral Exablate thalamotomy with at least 9 months since first intervention.
- Available tremor assessment prior to unilateral Exablate thalamotomy.
- Willing and able to remain in the study for at least 6 months and complete required assessments.
You will not qualify if you...
- Experienced any non-transient neurological event or worsening after previous Exablate procedure.
- MRI contraindications such as incompatible metallic implants, severe claustrophobia, or contrast medium reaction.
- Presence of energy absorbing structures or sensitive tissues in the ultrasound path (e.g., skull implants, surgical clips).
- Active infections or severe allergies with fever.
- Diagnosed brain tumors or vascular anomalies.
- History of seizures, brain hemorrhages, stroke within past year, or coagulopathy.
- Use of anticoagulants or anti-platelet drugs increasing bleeding risk.
- Received contrast agent within 24 hours before treatment.
- Severe unstable hypertension not controlled by medication (diastolic BP > 100).
- Unstable cardiac status.
- Behavior consistent with ethanol or substance abuse.
- Cerebrovascular disease (multiple CVA or CVA within 6 months).
- Risk factors for intraoperative or postoperative bleeding.
- Abnormal brain imaging findings (tumor, vascular malformation, shunt).
- Physical subscale score ≥ 16.5 on Dysphagia Handicap Index or diagnosed dysphagia.
- Cognitive impairment.
- Clinically significant abnormal speech function as determined by a speech pathologist.
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Turku University Hospital
Turku, Finland, FI20520
Actively Recruiting
2
Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)
Kiel, Germany, 24105
Actively Recruiting
3
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy, 20133
Actively Recruiting
4
Germans Trias i Pujol Hospital
Badalona, Spain, 08916
Actively Recruiting
5
HM CINAC- Hospital Universitario HM Puerta del Sur
Móstoles, Spain, 28938
Actively Recruiting
6
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
7
Ascires Hospital_ECG Salud
Valencia, Spain, 46014
Active, Not Recruiting
8
The Walton Center
Liverpool, United Kingdom, L97LJ
Not Yet Recruiting
Research Team
P
Pascalle Reiters
CONTACT
I
Insightec
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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