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Procedure
Transcranial MRgFUS for Parkinson's Disease
N/A
Waitlist Available
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 at the time of exablate trascranial procedure
Awards & highlights
No Placebo-Only Group
Summary
This trialwill test the safety and effectiveness of a non-invasive treatment to reduce dyskinesia in Parkinson's patients.
Eligible Conditions
- Parkinson's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the time of exablate trascranial procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of exablate trascranial procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Device and Procedure related adverse events
Secondary study objectives
Severity of Device and Procedure related adverse events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Transcranial ExAblateExperimental Treatment1 Intervention
Transcranial ExAblate MRgFUS
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial ExAblate
2015
N/A
~140
Find a Location
Who is running the clinical trial?
InSightecLead Sponsor
91 Previous Clinical Trials
3,792 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of bleeding inside your brain.You have an infection that is not being treated or controlled.You have a serious illness that could be life-threatening.You have had a recent heart attack, unstable angina, or severe heart failure that requires medication.You are at risk for bleeding during or after surgery due to low platelet count or a blood clotting problem.You have a brain tumor.You have had specific types of brain surgeries called deep brain stimulation or stereotactic ablation of the basal ganglia.You have a weakened immune system, such as being HIV positive.You are between 18 and 80 years old.You have very poor kidney function or are on dialysis.You have a neurological condition like multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, or Alzheimer's disease.You have significant problems with thinking and remembering, as determined by a test called the Mini Mental Status Examination (MMSE) with a score of 24 or lower.You have had multiple strokes or a stroke within the past 6 months.You can't or don't want to stay lying down for a long time during treatment.You have metal implants or devices that are not safe for MRI scans.You are allergic to the MRI contrast agent or have advanced kidney disease.You have symptoms like headache, nausea, vomiting, and other signs that suggest pressure inside your head is too high.You have taken blood-thinning medication like warfarin or aspirin within one week of the procedure, or drugs that increase the risk of bleeding within one month of the procedure.You have had seizures in the last year.You can tell the doctor how you feel during the treatment.You have a psychiatric illness that is not well controlled, or you have experienced symptoms of psychosis, depression, or have received certain types of treatment for your psychiatric condition.You have a history of unusual bleeding or blood clotting problems.
Research Study Groups:
This trial has the following groups:- Group 1: Transcranial ExAblate
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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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