Evaluation of the Safety and Effectiveness of Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD)
1 other identifier
interventional
50
3 countries
9
Brief Summary
Evaluate the Safety and Effectiveness of Staged Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started May 2021
Longer than P75 for not_applicable parkinson-disease
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2021
CompletedFirst Posted
Study publicly available on registry
January 28, 2021
CompletedStudy Start
First participant enrolled
May 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
ExpectedFebruary 17, 2025
February 1, 2025
2.9 years
January 14, 2021
February 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III OFF Medication
OFF-medication, Upper + Lower Extremity motor score from the MDS-UPDRS Part III comparing Month 3 post Bilateral treatment to Baseline. Lower score on the scale means a better outcome.
Up to Month 3 post Bilateral Treatment
Secondary Outcomes (1)
MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part II
Up to Month 12 post Bilateral Treatment
Other Outcomes (2)
MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III OFF Medication
Up to Month 12 post Bilateral Treatment
MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part IV
Up to Month 12 post Bilateral Treatment
Study Arms (1)
Exablate Pallidothalamic Tractotomy
EXPERIMENTALExablate treatment for Advanced Idiopathic Parkinson's Disease
Interventions
Exablate Pallidothalamic Tractotomy
Eligibility Criteria
You may qualify if:
- Men and women, age 30 years and older, desiring bilateral treatment option with second side staged at 6 months.
- Subject is able and willing to give informed consent and able to attend all study visits
- Subject with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
- Motor complications of PD on optimum medical treatment
- Subject is on a stable dose of all PD medications for 30 days prior to screening visit
- Subject is able to communicate sensations during the Exablate procedure.
You may not qualify if:
- Subject where there is suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
- Subject with significant cognitive impairment as determined by the neuropsychologist.
- Subject has 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.
- Subject with unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation
- Women of childbearing potential who are pregnant or lactating
- Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
- Subject with unstable cardiac status or severe hypertension including:
- Documented myocardial infarction within six months of enrollment
- Unstable angina on medication
- Unstable or worsening congestive heart failure
- Left ventricular ejection fraction below the lower limit of normal
- History of a hemodynamically unstable cardiac arrhythmia
- Cardiac pacemaker
- Diastolic BP \> 100 on medication
- Subject with history of abnormal bleeding, hemorrhage, or coagulopathy including:
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InSighteclead
Study Sites (9)
Stanford
Palo Alto, California, 94304, United States
Delray Medical Center
Delray Beach, Florida, 33484, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Maryland, Baltimore
Baltimore, Maryland, 21201, United States
New York University Langone
New York, New York, 10016, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Neurology, Hospital Universitario HM Puerta del Sur (HM CINAC)
Madrid, Spain
ClĂnica Universidad de Navarra
Pamplona, Spain
Chang Bing Show Chwan Memorial Hospital
Lugang, Changhua County, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2021
First Posted
January 28, 2021
Study Start
May 14, 2021
Primary Completion
March 28, 2024
Study Completion (Estimated)
December 1, 2028
Last Updated
February 17, 2025
Record last verified: 2025-02