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Procedure

Focused Ultrasound Pallidotomy 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
Subjects on stable antidepressant medications for at least 3 months
Men and women, age 30 years and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in udysrs and mds-updrs part iii motor exam score from before treatment to 3 months following treatment
Awards & highlights

Study Summary

This trial will test whether a new treatment for Parkinson's disease, focused ultrasound pallidotomy, is safe and effective.

Who is the study for?
This trial is for men and women over 30 with advanced Parkinson's disease who have not responded well to medications. Participants must be diagnosed by specific criteria, respond to Levodopa, and be on stable medication doses. They cannot have severe cognitive impairment or other neurodegenerative diseases, a history of certain brain procedures, uncontrolled blood pressure or bleeding disorders, kidney issues, MR contraindications like severe claustrophobia or weight limits.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of ExAblate Pallidotomy—a focused ultrasound procedure—against a sham (fake) version for managing dyskinesia symptoms in Parkinson's patients. It involves one group receiving the real treatment while another receives a non-therapeutic procedure to compare outcomes.See study design
What are the potential side effects?
Potential side effects may include discomfort during the procedure, risk of bleeding due to ultrasound exposure, possible skin burns from MRI components used during treatment, headache or dizziness post-procedure. There might also be risks associated with lying still for an extended period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on the same antidepressant for at least 3 months.
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I am 30 years old or older.
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My Parkinson's disease symptoms are severe without medication or I have complications despite treatment.
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I have been diagnosed with Parkinson's disease by a specialist.
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My Parkinson's symptoms are severe without medication or I have complications despite treatment.
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My Parkinson's disease medication dose has been stable for the last 30 days.
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I can communicate how I feel during the ExAblate procedure.
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My Parkinson's symptoms improve by at least 30% when I take my medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in udysrs and mds-updrs part iii motor exam score from before treatment to 3 months following treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in udysrs and mds-updrs part iii motor exam score from before treatment to 3 months following treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Responder Analysis
Secondary outcome measures
Severity of Device and Procedure related complications

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExAblate PallidotomyExperimental Treatment1 Intervention
ExAblate treatment for Advanced Idiopathic Parkinson's Disease
Group II: Sham ExAblate PallidotomyPlacebo Group1 Intervention
Sham (fake) treatment

Find a Location

Who is running the clinical trial?

InSightecLead Sponsor
88 Previous Clinical Trials
3,612 Total Patients Enrolled

Media Library

ExAblate Pallidotomy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03319485 — N/A
Parkinson's Disease Research Study Groups: ExAblate Pallidotomy, Sham ExAblate Pallidotomy
Parkinson's Disease Clinical Trial 2023: ExAblate Pallidotomy Highlights & Side Effects. Trial Name: NCT03319485 — N/A
ExAblate Pallidotomy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03319485 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites are actively managing this research endeavor?

"This research initiative is recruiting patients from the Pennsylvania Hospital Department of Neurosurgery in Philadelphia, Swedish Medical Center in Seattle and Mayo Clinic in Rochester. Plus, there are 12 additional clinical trial sites across America."

Answered by AI

Are there still vacancies available for prospective participants in this trial?

"The information on clinicaltrials.gov indicates that this particular research effort is now closed to recruitment, having first been posted on February 9th 2018 and last updated November 5th 2020. Nevertheless, there are over 500 other medical studies actively recruiting participants at the moment."

Answered by AI

Who else is applying?

What state do they live in?
Washington
What site did they apply to?
Swedish Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease
2018. "ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03319485.
All > Parkinsons Disease > Parkinson
~10 spots leftby Jan 2025
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