Focused Ultrasound Thalamotomy for Tremor Relief in Atypical Parkinsonism (FUSAP)

January 11, 2024 updated by: Ilana Schlesinger, Rambam Health Care Campus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients that underwent FUS VIM-thalamotomy and suffered from MSA or DLBD

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Rating Scale for Tremor
Time Frame: baseline, pre-procedure, 1 month, 6 months and 1 year following procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

December 31, 2023

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMB-0404-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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