🏛️ Verified NIH Record • Updated 2026-03-18

A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications (NCT05539196)

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: InSightec

🩺 Plain-English Summary (8th-Grade Level)

This registry is a prospective, multicenter, international, single arm, observational post-approval registry with follow-up at 3, 6, and 12 months, and annually for 5 years. The proposed registry will enroll 60 subjects and will be conducted at approximately 10 centers worldwide.

Who can join: Review the eligibility criteria below.

Location: University of Maryland, Baltimore — Baltimore, Maryland

Age range: 30 Years to 99 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (5 Sites)

  • University of Maryland, Baltimore — Baltimore, Maryland
  • Weill Cornell Medicine — New York, New York
  • University of Pennsylvania — Philadelphia, Pennsylvania
  • University of Texas Southwestern Medical Center — Dallas, Texas
  • Ohnishi Neurological Center — Akashi, Hyōgo

📞 Contact the Study Coordinator

Phone: (214) 304-8265

Email: clinicalresearchquestions@insightec.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗