NCT06204575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

9.6 years

First QC Date

December 31, 2023

Last Update Submit

January 11, 2024

Conditions

Keywords

focused ultrasoundtremorsurgerythalamotomy

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Data collection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

MeSH Terms

Conditions

Lewy Body DiseaseMultiple System AtrophyThyroid Dyshormonogenesis 2ATremor

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersPrimary DysautonomiasAutonomic Nervous System DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Movement Disorders Institute, clinical senior lecturer, Chair of Neurology, Rappaport Faculty of Medicine, Technion-Israel Institute of Technology Haifa, Israel

Study Record Dates

First Submitted

December 31, 2023

First Posted

January 12, 2024

Study Start

November 1, 2013

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

January 12, 2024

Record last verified: 2024-01

Locations