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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
Study 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Device and Procedure related adverse events
Secondary outcome measures
Severity of Device and Procedure related adverse events
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
2013
N/A
~80
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Who is running the clinical trial?
InSightecLead Sponsor
89 Previous Clinical Trials
3,708 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment for this experiment open to octogenarians?
"The age range for this trial is 18 to 80, with 26 trials that cater exclusively to the younger demographic and 494 trials specifically targeting individuals over 65."
Answered by AI
Are there any openings available for me to partake in this investigation?
"This clinical trial is accepting a total of 6 participants who have been clinically diagnosed with Parkinson's disease (PD) and are within the age range of 18 - 80."
Answered by AI
Is this clinical research actively seeking participants?
"According to its listing on clinicaltrials.gov, this medical trial is not currently looking for new participants despite having been initially posted in September 2014 and last updated in December 2022. Nevertheless, 497 other studies are actively searching for volunteers at present time."
Answered by AI
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