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A Clinical Trial for the Safety and Effect of MRGuided FUS Subthalamotomy for Medication Refractory Parkinson's Disease

NCT04744493 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-03-06

No results posted yet for this study

Summary

Study design: This is a prospective, open-label, single-center, and sponsor-initiated clinical trial. The clinical trial follows the Clinical Investigation Plan, GCP. Objective: The objective of the clinical trial is to evaluate improving Parkinson's disease motor features by MR-guided focused ultrasound surgery (Patient who has less effectiveness.).

Conditions

  • Parkinson Disease

Interventions

DEVICE

ExaBlate 4000

The Exablate 4000, an advanced, non-invasive technique for performing ablation of the Thalamus for treating Essential Tremor, received FDA PMA (P150038) approval for unilateral treatment of Essential Tremor in 2016.

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2022-05-31
Completion
2022-07-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04744493 on ClinicalTrials.gov