A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease

NCT04991831 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-03-20

No results posted yet for this study

Summary

The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.

Conditions

  • Tremor Associated With Tremor Dominant Parkinson's Disease

Interventions

DEVICE

Unilateral thalamotomy

Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Eligibility

Min Age
30 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United States
  • United Kingdom

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 NCT04991831 on ClinicalTrials.gov