Montreal Cognitive Assessment Index Following MRI Guided... | NCT06941285

Studies
Montreal Cognitive Assessment Index Following MRI Guided Focused Ultrasound Thalamotomy

NCT06941285

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Apr 23, 2025Actual

Enrollment

142Actual

Phase

Not provided

Conditions

Essential Tremor

Interventions

Data collection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2013Actual

Primary Completion Date

Jun 1, 2024Actual

Completion Date

Jun 1, 2024Actual

First Submitted Date

Apr 16, 2025

First Submission Date that Met QC Criteria

Apr 16, 2025

First Posted Date

Apr 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2025

Last Update Posted Date

Apr 23, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ilana Schlesinger, Director Movement Disorders Institute, Rambam Health Care CampusPrincipal Investigator

Lead Sponsor

Rambam Health Care CampusOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We assessed Montreal Cognitive Assessment scores before and after MRI guided focused ultrasound thalamotomy for tremor in order to identify if there are changes in cognitive function following treatment.

Detailed Description

All patients who underwent MRI guided focused ultrasound thalamotomy underwent cognitive assessment by Montreal Cognitive Assessment. We calculated the scores before and after treatment and compared the results.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

142Actual

Name	Type	Description	Arm Group Labels	Other Names
Data collection	Other	Data collection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Montreal Cognitive Assessment	Cognitive assessessment with higher score indicating better cognitive state	baselin, preprocedure, 6 months and 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients that underwent MRI guided focused ultrasound thalamotomy and suffered from Essential tremor.

Exclusion Criteria:

Patients that did not undergo MRI guided focused ultrasound thalamotomy
Patinets that did not suffer from Essential tremor.
Patients that underwent MRI guided focused ultrasound for areas other then a thalamus
Patients tat underwent bilateral thalamothomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients that underwent MRI guided focused ultrasound thalamotomy and suffered from Essential tremor.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Inna Senderova	Rambam Health Care Campus	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020329	Essential Tremor

Ancestor Terms

ID	Term
D009069	Movement Disorders
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003625	Data Collection

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided