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ExAblate Transcranial MRgFUS for Unilateral Pallidotomy for the Treatment of Parkinson's Disease

StatusActive, Not Recruiting
PhaseNot applicable
SponsorInSightec
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 1, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jun 2023 to Jun 2026 Completion date: Dec 2023 to Dec 2026v12 Show 1 more changeShow less
    • Completion date: Dec 2023 to Dec 2026
  2. Primary completion date: Dec 2020 to Jun 2023 Completion date: Dec 2020 to Dec 2023v11 Show 1 more changeShow less
    • Completion date: Dec 2020 to Dec 2023
  3. Trial status: Recruiting to Active, Not Recruiting Site details revisedv10 Show 1 more changeShow less
    • Site details revised
  4. Primary and study completion dates: Dec 2019 to Dec 2020v9
  5. Primary and study completion dates: Dec 2018 to Dec 2019v8
Show 6 earlier versionsHide 6 earlier versions
  1. Primary and study completion dates: Dec 2017 to Dec 2018v7
  2. Primary and study completion dates: Dec 2016 to Dec 2017v6
  3. Re-verified, no change to tracked fieldsv5
  4. Primary and study completion dates: Dec 2015 to Dec 2016v4
  5. Site contact updatedv3
  6. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
InSightec
42 trials monitored
See 1 trial at risk
Parkinson's Disease
1,435 trials monitored
See 62 trials at risk
The proposed study is to evaluate the safety and initial effectiveness of the ExAblate Transcranial MRgFUS) treatment of patients with L-dopa induced dyskinesia of Parkinson's disease (LID PD). Safety: To evaluate the incidence and severity of adverse events associated with ExAblate Transcranial 4000 MRgFUS treatment of dyskinesia of Parkinson's disease. Effectiveness: To determine the level of effectiveness of the ExAblate Transcranial MRgFUS treatment of LID in PD patients. Efficacy will be determined utilizing clinical rating scales for dyskinesia (UPDRS-IV and the Unified Dyskinesia Rating Scale) from examinations at Baseline, 3-Months and 12-Months post-ExAblate treatment.
Trial Details
NCT Number NCT02347254
Lead Sponsor InSightec
Conditions Parkinson's Disease
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov