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Procedure
Exablate Ablation 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
Subject is on a stable dose of all PD medications for 30 days prior to screening visit
Motor complications of PD on optimum medical treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 12 post bilateral treatment
Awards & highlights
Study Summary
This trial will study whether a new treatment for Parkinson's disease is safe and effective.
Who is the study for?
This trial is for men and women aged 30 or older with Parkinson's Disease who want a bilateral treatment option, can give informed consent, attend all visits, are on stable PD medication doses for 30 days prior to screening, can communicate during the procedure, and have motor complications despite optimal medical treatment. Exclusions include pregnant/lactating women, substance abuse behaviors, other neurodegenerative diseases or significant cognitive impairment, unstable psychiatric disease or cardiac status, bleeding risks including low platelets/coagulopathy/stroke history/anticoagulant use within specific timeframes before the procedure.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a staged bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) in treating motor complications in Parkinson's Disease patients. The intervention involves using Exablate 4000 technology with one side treated initially and the second side six months later.See study design
What are the potential side effects?
Potential side effects may include discomfort from lying still during treatment; risks associated with MRI such as reactions to metal implants; possible skin burns from focused ultrasound energy; neurological symptoms like weakness or numbness; speech problems; balance issues; headache or dizziness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Parkinson's disease medication dose has been stable for the last 30 days.
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I experience movement issues due to Parkinson's despite taking my medication.
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I have been diagnosed with Parkinson's disease by a specialist.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to month 12 post bilateral treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 12 post bilateral treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part II
Other outcome measures
MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III OFF Medication
MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part IV
Trial Design
1Treatment groups
Experimental Treatment
Group I: Exablate Pallidothalamic TractotomyExperimental Treatment1 Intervention
Exablate treatment for Advanced Idiopathic Parkinson's Disease
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Who is running the clinical trial?
InSightecLead Sponsor
88 Previous Clinical Trials
3,654 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You show signs of alcohol or drug abuse.My Parkinson's disease medication dose has been stable for the last 30 days.I have been diagnosed with a neurodegenerative disease like Alzheimer's.You have a history of abnormal bleeding, blood clotting issues, or certain medical conditions that increase the risk of bleeding. You also have certain health conditions like severe kidney problems, recent seizures, brain tumors, or life-threatening diseases that prevent you from participating in the study. Additionally, if you have certain medical devices in your body or have recently participated in another clinical trial with an active treatment, you may be excluded from this study.I might have Parkinson-like symptoms due to my medication.You have severe problems with memory or thinking, as determined by a specialist.I do not have severe heart problems or very high blood pressure.I experience movement issues due to Parkinson's despite taking my medication.I am not pregnant or breastfeeding.I am 30 or older and interested in treatment for both sides, with the second side treated 6 months later.I do not have uncontrolled mental health issues like severe depression, psychosis, or thoughts of harming myself.I have been diagnosed with Parkinson's disease by a specialist.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities to join this research program at present?
"The clinical trial, which was first uploaded to clinicaltrials.gov on May 14th 2021 and last updated July 11th 2022, is not presently enrolling patients. However, there are 488 other experiments that have openings for participants at the present time."
Answered by AI
Are any healthcare facilities administering this investigation within the state?
"This research is being conducted at NYU Langone in New york City, Weill Cornell Medicine located near Palo Alto, and Stanford University situated in Baltimore. Moreover, 6 other sites are also participating."
Answered by AI
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