Focused Ultrasound Thalamotomy for Tremor Relief in Atypi... | NCT06204575

Studies
Focused Ultrasound Thalamotomy for Tremor Relief in Atypical Parkinsonism

NCT06204575

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Jan 12, 2024Actual

Enrollment

8Actual

Phase

Not provided

Conditions

Atypical Parkinsonism
Dementia With Lewy Bodies
Multiple System Atrophy, MSA

Interventions

Data collection

Countries

Israel

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

Jan 2024

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

May 31, 2023Actual

Completion Date

May 31, 2023Actual

First Submitted Date

Dec 31, 2023

First Submission Date that Met QC Criteria

Jan 11, 2024

First Posted Date

Jan 12, 2024Actual

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

Jan 11, 2024

Last Update Posted Date

Jan 12, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ilana Schlesinger, Director Movement Disorders Institute, clinical senior lecturer, Chair of Neurology, Rappaport Faculty of Medicine, Technion-Israel Institute of Technology Haifa, Israel, Rambam Health Care CampusPrincipal Investigator

Lead Sponsor

Rambam Health Care CampusOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

The goal of this retrospective observational study is to describe the efficacy of focused ultrasound ventral-intermediate nucleus thalamotomy in patients with atypical parkinsonism.

Is this treatment efficacious in patients with multiple system atrophy?
Is this treatment efficacious in patients with diffuse Lewy Body Dementia? Data will be collected from patients charts.

Detailed Description

Not provided

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

8Actual

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Rating Scale for Tremor	tremor assessment by Clinical Rating Scale for Tremor. Scores ranging from 0 to 156, with higher scores indicating more severe tremor.	baseline, pre-procedure, 1 month, 6 months and 1 year following procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Patients that underwent FUS ventral-intermediate nucleus thalamotomy Suffer from multiple system atrophy-Parkinsonian type (MSA-P) or dementia with Lewy bodies (DLBD).

Exclusion Criteria:

Patients that did not underwent FUS ventral-intermediate nucleus thalamotomy
Patients that underwent FUS ventral-intermediate nucleus thalamotomy and do not suffer from MSA or DLBD

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 FUS VIM-thalamotomy and suffered from MSA or DLBD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Health Care Campus		Haifa		3109601	Israel

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
D020961	Lewy Body Disease
D019578	Multiple System Atrophy
C563206	Thyroid Dyshormonogenesis 2A
D014202	Tremor

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central 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