ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03319485|
Recruitment Status : Active, not recruiting
First Posted : October 24, 2017
Last Update Posted : November 9, 2020
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: ExAblate Pallidotomy Device: Sham ExAblate Pallidotomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Pivotal Clinical Trial of the Management of the Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Idiopathic Parkinson's Disease With Unilateral Lesioning of the Globus Pallidum Using the ExAblate Neuro System|
|Actual Study Start Date :||February 9, 2018|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||January 31, 2025|
Experimental: ExAblate Pallidotomy
ExAblate treatment for Advanced Idiopathic Parkinson's Disease
Device: ExAblate Pallidotomy
ExAblate Pallidotomy for Parkinson's Disease
Sham Comparator: Sham ExAblate Pallidotomy
Sham (fake) treatment
Device: Sham ExAblate Pallidotomy
ExAblate MRgFUS Sham Procedure
- Responder Analysis [ Time Frame: Change in UDysRS and MDS-UPDRS Part III Motor Exam score from before treatment to 3 months following treatment ]Responder is defined as the patient reaching a minimally clinically significant difference on: 1. UDysRS (this measures dyskinesia and their impact) OR 2. MDS-UPDRS Part III Motor Exam -Total score (this measures overall motor fluctuations).
- Severity of Device and Procedure related complications [ Time Frame: At the time of ExAblate Pallidotomy procedure ]To evaluate of the incidence and severity of device- and procedure-related
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||30 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
- Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia.
- Presence of significant cognitive impairment using MMSE ≤ 24.
- Unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation.
- Subjects with an active alcohol or drug dependency or history of drug/alcohol abuse within the past year
- Subjects with unstable cardiac status
- Severe hypertension (diastolic BP > 100 on medication).
- Current medical condition resulting in abnormal bleeding and/or coagulopathy.
- Receiving anticoagulant (e.g., warfarin) or antiplatelet (e.g., aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g., Avastin) within one month of focused ultrasound procedure.
- Subjects with risk factors for intraoperative or postoperative bleeding as indicated by: platelet count less than 100,000 per cubic millimeter; a documented clinical coagulopathy; or INR coagulation studies exceeding the institution's laboratory standard
- Patient with kidney disease or on dialysis.
- Subjects with standard contraindications for MR imaging
- Significant claustrophobia that cannot be managed with mild medication.
- Subjects who weigh more than the upper weight limit of the MR scanner table and who cannot fit into the MR scanner.
- Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment.
- History of intracranial hemorrhage, multiple strokes, or a stroke within past 6 months.
- Subjects with a history of seizures within the past year.
- Subjects with brain tumors.
- Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment.
- Are participating or have participated in another clinical trial in the last 30 days.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319485
|Other Study ID Numbers:||
|First Posted:||October 24, 2017 Key Record Dates|
|Last Update Posted:||November 9, 2020|
|Last Verified:||November 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases