ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanc… (NCT03319485) | Clinical Trial Compass
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ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease
United States92 participantsStarted 2018-02-09
Plain-language summary
Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.
Who can participate
Age range30 Years
SexALL
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Inclusion criteria
✓. Men and women, age 30 years and older.
✓. Subjects who are able and willing to give informed consent and able to attend all study visits through 12 Months.
✓. Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
✓. Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor subscale in the ON vs OFF medication state.
✓. MDS-UPDRS score of ≥ 20 in the meds OFF condition OR Motor complications of PD on optimum medical treatment .
✓. Subjects should be on a stable dose of all PD medications for 30 days prior to study entry as determined by medical records.
✓. Subject is able to communicate sensations during the ExAblate procedure.
✓. Subjects on stable antidepressant medications for at least 3 months
Exclusion criteria
✕. Hoehn and Yahr stage in the ON medication state of 3 or greater.
✕. Presence of other central neurodegenerative disease suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, and Alzheimer's disease.
✕. Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
What they're measuring
1
Responder Analysis
Timeframe: Change in UDysRS and MDS-UPDRS Part III Motor Exam score from before treatment to 3 months following treatment