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Unilateral and Staged Bilateral Pallidothalamic Tractotomy Using Exablate MRgFUS in Advanced Parkinson's Disease.

NCT07764874 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-14

No results posted yet for this study

Summary

This study is a randomized clinical trial evaluating a focused ultrasound treatment for people with advanced Parkinson's disease (PD) who have disabling motor complications and symptoms.

The study uses the Exablate Neuro System, which delivers MR-guided Focused Ultrasound (MRgFUS). This technology focuses ultrasound energy on a specific brain target and generates heat to create a small lesion (ablation) without making a surgical incision.

The target in this study is the Pallidothalamic Tract (PTT), a pathway involved in the abnormal brain circuits that contribute to Parkinson's symptoms and complications.

This study is evaluating whether treating one side of the brain or treating both sides (in separate procedures) provides better outcomes for people with advanced Parkinson's disease who have motor complications and symptoms.

The main outcome measure is the change in the MDS-UPDRS Part III Upper/Lower Extremity (ULE) score at 3 months after first and second side treatment, compared with the respective control groups.

MDS-UPDRS Part III is a standard clinical scale used to assess Parkinson's motor symptoms. ULE score focuses on motor function in the arms and legs. Assessments are performed in the OFF-medication state, meaning Parkinson's medications are temporarily withheld so that the treatment effect can be measured more accurately.

In addition improvement in motor complications will be assessed with MDS-UPDRS Part IV and Patient diaries.

Conditions

  • Parkinson Disease

Interventions

DEVICE

Unilateral Exablate MRgFUS Pallidothalamic Tractotomy

1st side Exablate MRgFUS Pallidothalamic Tractotomy for Parkinson's Disease

DEVICE

Staged Bilateral Exablate Pallidothalamic Tractotomy

2nd side staged Exablate MRgFUS Pallidothalamic Tractotomy for Parkinson's Disease

DRUG

Best Medical Treatment (BMT)

Subjects will be managed according to conventional therapeutic guidelines (i.e., best medical treatment) for Parkinson's Disease

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Principal Investigators

  • Joohi Jimenez-shahed, MD · Mount Sinai, Clinical Neurosciences Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-12-31
Completion
2031-06-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07764874 on ClinicalTrials.gov