NCT02347254 · ClinicalTrials.gov record · last posted 2025-05-01
ExAblate Transcranial MRgFUS for Unilateral Pallidotomy for the Treatment of Parkinson's Disease
StatusActive, Not Recruiting
PhaseNot applicable
Started2014-09
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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.
from the ClinicalTrials.gov record
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.
Amendment record
11 amendments on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended 11 times since 2015-01-21; most recent amendment 2025-04-30. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
See every version on ClinicalTrials.gov ↗
2020-03-09
Status change Recruiting→Active, Not Recruitingv9
| NCT Number |
NCT02347254 |
| Lead Sponsor |
InSightec
|
| Conditions |
Parkinson's Disease |
| Enrollment |
6 participants |
| Start Date |
2014-09 |
| Primary Completion |
2026-06 (estimated) |
| Study Completion |
2026-12 (estimated) |
| Updated on ClinicalTrials.gov |
2025-05-01 |