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Ultrasound Therapy
Transcranial MRgFUS for Parkinson's Disease
N/A
Waitlist Available
Led By Jeff Elias, MD
Research Sponsored by InSightec
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12-months post treatment
Summary
This trial is to see if a new treatment for Parkinson's disease is safe.
Eligible Conditions
- Parkinson's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12-months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12-months post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence and severity of adverse events
Mean change in MDS-UPDRS Part III scores
Secondary study objectives
Long Term Adverse Events Profile
Other study objectives
Mean change in MDS-UPDRS Part IV scores
Mean change in MDS-UPDRS total score
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExAblate Treated ArmExperimental Treatment1 Intervention
ExAblate Transcranial System subthalamotomy for motor symptoms of Parkinson's Disease.
Group II: ExAblate Sham Treated ArmPlacebo Group1 Intervention
ExAblate Transcranial System sham subthalamotomy for motor symptoms of Parkinson's Disease. Sham subjects completing the 4 Month visit may be offered the actual ExAblate subthalamotomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ExAblate Transcranial System
2011
N/A
~30
Find a Location
Who is running the clinical trial?
InSightecLead Sponsor
91 Previous Clinical Trials
3,791 Total Patients Enrolled
Jeff Elias, MDPrincipal InvestigatorUniversity of Virginia
1 Previous Clinical Trials
12 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are at stage 2.5 or higher on the Hoehn and Yahr scale when taking your medication.You have severe difficulty with movement as determined by specific questions on a medical assessment.You have signs of other brain diseases, such as multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, or Alzheimer's disease.You have had more than one stroke, or a stroke in the last 6 months.Your skull density ratio, calculated from a CT scan, is less than 0.40.People who are 30 years old or older.You have been diagnosed with Parkinson's disease by a movement disorder neurologist using specific criteria.If there's a concern that the symptoms of Parkinson's disease are caused by certain medications for mental illness.You have previously had a deep brain stimulation or a targeted ablation procedure in the basal ganglia.You have a significant problem with memory or thinking, as shown by a specific test score.You have been diagnosed with severe depression by a neuropsychologist using a test called the Beck Depression Inventory, where you scored higher than 14.You have heart problems that are not well controlled, a recent heart attack, or a history of abnormal bleeding or clotting issues.You have had bleeding inside your head in the past.You have had a seizure in the past year.You have a brain tumor.You have a type of blood vessel problem in your brain that needs to be treated.You have severe movement problems that are not well managed with medication.The subthalamic nucleus can be seen on an MRI, so the ExAblate device can be used to target it.Before taking any medication, your motor skills score should be 35 or higher on the MDS-UPDRS test.You have very poor kidney function and are on dialysis.You have severe claustrophobia that cannot be helped with mild medication.You are not able to lie still for a long time during treatment, or you don't want to.You have severe, uncontrolled mental health issues such as ongoing strong feelings of sadness, seeing or hearing things that aren't there, or thoughts of harming yourself. If you have long-term anxiety or depression that is well managed with medication, you may still be able to take part in the study.You show signs of alcohol or drug abuse according to specific guidelines.You have conditions that make it unsafe for you to have a magnetic resonance imaging (MRI) scan.Your symptoms improve by at least 30% when you take levodopa medication.You have significant disability on one side of your body, as determined by specialists who treat movement disorders.
Research Study Groups:
This trial has the following groups:- Group 1: ExAblate Sham Treated Arm
- Group 2: ExAblate Treated Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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