Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
Study NCT ID:
NCT06974916
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EMBRACE Tremor BiFUS
Sponsor:
InSightec
Organization:
Study Overview
Official Title:
European, Multicenter, Investigator Blinded, Randomized And Controlled Essential Tremor Trial With Staged-Bilateral FUS
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: