Focused Ultrasound Pallidotomy for Parkinson's Disease
Recruiting at 19 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: InSightec
Must be taking: Levodopa, Antidepressants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
What is the purpose of this trial?
Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.
Are You a Good Fit for This Trial?
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.Inclusion Criteria
I have been on the same antidepressant for at least 3 months.
You can tell how you are feeling during the procedure.
Subjects who are able and willing to give informed consent and able to attend all study visits through 12 Months
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Exclusion Criteria
My Parkinson's disease is advanced, affecting my physical movements even with medication.
I have been diagnosed with a neurodegenerative disease like Alzheimer's.
I have a condition that causes abnormal bleeding or blood clotting issues.
See 19 more
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive unilateral focused ultrasound pallidotomy using the ExAblate 4000 System
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 months
Multiple visits (in-person)
What Are the Treatments Tested in This Trial?
Interventions
- ExAblate Pallidotomy
- Sham ExAblate Pallidotomy
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExAblate PallidotomyExperimental Treatment1 Intervention
Group II: Sham ExAblate PallidotomyPlacebo Group1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
InSightec
Lead Sponsor
Trials
92
Recruited
3,800+
Dr. Maurice R. Ferré
InSightec
Chief Executive Officer
MD
Dr. Arjun Desai
InSightec
Chief Medical Officer
MD
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