---
title: Reduce medication refractory motor complications
nct_id: NCT05539196
status: RECRUITING
sponsor: InSightec
study_type: OBSERVATIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT05539196"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05539196"
last_fetched: "2026-05-10T14:04:09.716Z"
source: "Parkinson's Pathways (curated)"
---
# Reduce medication refractory motor complications

**Goal (in five words):** Reduce medication refractory motor complications

**Official Title:** 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

**Trial ID:** [NCT05539196](https://clinicaltrials.gov/study/NCT05539196)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Sponsor:** InSightec
- **Target Enrollment:** 60 participants
- **Start Date:** 2023-01-23
- **Completion Date:** 2029-07-31
- **Conditions:** Movement Disorders, Neurology, Parkinsons Disease
- **Interventions:** Exablate Pallidotomy, Unilateral
- **Intervention Types:** DEVICE

## Summary For Families

The goal is to track real-world outcomes after using Exablate pallidotomy to reduce medication-refractory moderate to severe motor complications in people with advanced, idiopathic Parkinson's disease. The approach uses the Exablate 4000 MR-guided focused ultrasound device to make a precise, one-time lesion in the globus pallidus on one side of the brain, interrupting abnormal circuits that cause dyskinesia and motor fluctuations without open surgery. It is meant for problems that do not respond well to levodopa and other meds; it may reduce troublesome dyskinesia or off periods but does not directly replace levodopa. The registry is enrolling adults aged 30 to 99 who are already planning a unilateral Exablate procedure at their treating center and who can consent and complete follow-up visits.

## Eligibility

- **Minimum age:** 30 Years
- **Maximum age:** 99 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

* Men and women, age 30 years and older.
* Subject undergoing a planned an Exablate procedure for their Parkinson's Disease with Motor Complications per local institution standard of care.
* Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all Registry visits.
* Subject has signed and received a copy of the approved informed consent form.

Exclusion Criteria:

* Subject does not agree to participate or is unlikely to participate for the entirety of the Registry.
```

## Locations (5)

- University of Maryland, Baltimore, Baltimore, Maryland, United States _(39.2904, -76.6122)_
  - Kaitlyn Henry — (CONTACT) — 410-328-0939 — KHenry@som.umaryland.edu
  - Howard Eisenberg, MD — (PRINCIPAL_INVESTIGATOR)
- Weill Cornell Medicine, New York, New York, United States _(40.7143, -74.0060)_
  - Rachel Olovyannikov — (CONTACT) — (212) 746-7373 — rao4005@med.cornell.edu
  - Isabella Cipollone — (CONTACT) — (203) 917-9918 — isc4005@med.cornell.edu
  - Michael Kaplitt, MD PhD — (PRINCIPAL_INVESTIGATOR)
- University of Pennsylvania, Philadelphia, Pennsylvania, United States _(39.9524, -75.1636)_
  - Giovanna Rocchio — (CONTACT) — 215-829-6720 — NPN@uphs.upenn.edu
  - Casey Halpern, MD — (PRINCIPAL_INVESTIGATOR)
- University of Texas Southwestern Medical Center, Dallas, Texas, United States _(32.7831, -96.8067)_
  - Claire Starcke — (CONTACT) — 214-645-1568 — Charlton.Starcke@UTSouthwestern.edu
  - Bhavya Shah, MD — (PRINCIPAL_INVESTIGATOR)
- Ohnishi Neurological Center, Akashi, Hyōgo, Japan _(34.6552, 135.0069)_
  - Naotaka Satou — (CONTACT) — +81-78-938-1238 — info@onc.akashi.hyogo.jp
  - Yoshihiro Kuga, MD — (PRINCIPAL_INVESTIGATOR)

## Central Contacts

- Kingsley Nwaogu — (CONTACT) — 2143048265 — clinicalresearchquestions@insightec.com
- Julia Zhu — (CONTACT) — 2148462577 — clinicalresearchquestions@insightec.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT05539196*  
*HTML version: https://parkinsonspathways.com/trial/NCT05539196*  
*Source data: https://clinicaltrials.gov/study/NCT05539196*