EMBRACE Tremor BiFUS

Sponsor
InSightec
Study ID
NCT06974916
Status
Recruiting
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Conditions

  • Essential Tremor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Staged bilateral Exablate thalamotomy — PROCEDURE
    Staged bilateral Exablate thalamotomy in ET patients
  • Local standard medical treatment after previous Exablate unilateral thalamotomy. — OTHER
    Local standard medical treatment

Study Details

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.

Key Dates

First listed
May 16, 2025
Start date
Apr 22, 2025
Status verified
Jun 2026
Primary completion
Jul 31, 2026
Completion
Mar 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Exablate Arm
    Subjects will receive staged bilateral Exablate thalamotomy.
  • Active Comparator: Control Arm
    Subjects will continue with their standard of care treatment for 6 months.

Primary Outcome Measure

Treated Upper Limb Clinical Rating Scale for Tremor (CRST) (A+B) (0-28) score for the treated side. [ Time Frame: 6 Months ]

Central Contacts

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