Abstract Details

Title Staged, Bilateral MR-guided Focused Ultrasound Pallidothalamic Tractotomy as a Treatment for Movement Disorders: Rationale and Design of a Parkinson’s Disease Study

Topic Movement Disorders

Presentation(s) P11 - Poster Session 11 (8:00 AM-9:00 AM)

Poster/Presentation
Number 5-026

Objective

To describe the rationale for magnetic resonance-guided focused ultrasound (MRgFUS) pallidothalamic tractotomy (PTT) as a staged, bilateral procedure to treat movement disorders conditions, such as Parkinson’s disease (PD), as an alternative to pallidal ablation.

Background

PTT has been described as an effective treatment to treat conditions such as dystonia and Parkinson’s disease (PD). MRgFUS offers a precise, incisionless method with the advantage of enabling a consistent and controlled disruption of the targeted brain circuits, to maximize effect and reduce risks. MRgFUS utilizes real time thermal feedback and stepwise energy titration, allowing for monitoring of reversible clinical effect and adjustment before definitive treatment. MRgFUS is approved for clinical use in essential tremor (staged, bilateral VIM target) and PD (unilateral VIM and GPi target). Staged, bilateral MRgFUS PTT for motor complications of PD phase III study has been completed and is under FDA review.

Design/Methods In a prospective, open label, single-arm, multicenter clinical trial, PD patients underwent a unilateral procedure (n=54) followed by a 2nd procedure (n=40), at least 6 months later. Patients were followed up for 12 months. Included were levodopa-responsive patients with troubling bilateral motor symptoms. Safety was assessed by the incidence and severity of device- and procedure-related adverse events. The primary efficacy endpoint is the OFF-medication, upper + lower extremity motor score from the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS Part III), comparing Month 3 post bilateral treatment to baseline. Multiple procedures/assessments were performed at scheduled clinical visits throughout the study.

Results

The study is registered at NCT04728295. Study is complete, and FDA review is in progress.

Conclusions

If successful, MRgFUS may expand to staged, bilateral PTT treatment of PD and other indications in the future.

Authors/Disclosures
Arif Dalvi, MD (Palm Beach Neuroscience Institute) PRESENTER	Dr. Dalvi has received personal compensation in the range of $0-$499 for serving as a Consultant for Insightec. Dr. Dalvi has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Acadia Pharmaceuticals. The institution of Dr. Dalvi has received research support from Insightec.
Lloyd Zucker, MD	Dr. Zucker has received research support from Insightec .
WEI CHIEH CHANG, MD	Dr. CHANG has nothing to disclose.
Peihan Wu, MD	Dr. Wu has nothing to disclose.
Michael Kaplitt, MD	No disclosure on file
Harini Sarva, MD, FAAN (Weill Cornell Medical Center)	Dr. Sarva has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novo Nordisk. Dr. Sarva has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neuroderm. Dr. Sarva has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Insightec. The institution of Dr. Sarva has received research support from Insightec. The institution of Dr. Sarva has received research support from NeuroNext. The institution of Dr. Sarva has received research support from Neuroderm. The institution of Dr. Sarva has received research support from Sun Pharma. The institution of Dr. Sarva has received research support from Prevail. The institution of Dr. Sarva has received research support from Bluerock Therapeutics. The institution of Dr. Sarva has received research support from Biogen. The institution of Dr. Sarva has received research support from Roche. The institution of Dr. Sarva has received research support from National Institute of Aging. The institution of Dr. Sarva has received research support from Michael J Fox Foundation. The institution of Dr. Sarva has received research support from Novo Nordisk. The institution of Dr. Sarva has received research support from Bukwang. The institution of Dr. Sarva has received research support from Bial. The institution of Dr. Sarva has received research support from Cerevance. The institution of Dr. Sarva has received research support from UCB. The institution of Dr. Sarva has received research support from MeiraGTX. The institution of Dr. Sarva has received research support from Biohaven. The institution of Dr. Sarva has received research support from Vima.
Howard Eisenberg (University of Maryland)	No disclosure on file
Paul S. Fishman, MD, PhD (Univ of Maryland Sch of Med)	No disclosure on file
Vivek Buch (Stanford University)	Vivek Buch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. Vivek Buch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neuropace.
Michele Matarazzo, MD (HM CINAC)	Dr. Matarazzo has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for International Parkinson and Movement Disorders Society. The institution of Dr. Matarazzo has received research support from Michael J Fox Foundarion.
MARTA DEL ALAMO, MD	Dr. DEL ALAMO has nothing to disclose.
Lain Hermes Gonzalez-Quarante, MD	Dr. Gonzalez-Quarante has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Insightec. Dr. Gonzalez-Quarante has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Siemens. Dr. Gonzalez-Quarante has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Rebrain. Dr. Gonzalez-Quarante has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for PALEX.
Maria C. Rodriguez-Oroz, MD, PhD	Dr. Rodriguez-Oroz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Insightec . Dr. Rodriguez-Oroz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific. Dr. Rodriguez-Oroz has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Insightec . Dr. Rodriguez-Oroz has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Boston Scientific. The institution of Dr. Rodriguez-Oroz has received research support from Spanish Government. The institution of Dr. Rodriguez-Oroz has received research support from Goverment of Navarra.
Sepehr Sani	The institution of Sepehr Sani has received research support from NIH. Sepehr Sani has received intellectual property interests from a discovery or technology relating to health care. Sepehr Sani has received publishing royalties from a publication relating to health care.
Michael Pourfar, MD (NYU)	Dr. Pourfar has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. Dr. Pourfar has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbott.
Alon Mogilner, MD, PhD	Dr. Mogilner has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for medtronic.
Gaganjot K. Sooch, MS, MBA	Mrs. Sooch has received personal compensation for serving as an employee of Insightec.
Cyril Ferrer, PhD	Dr. Ferrer has received personal compensation for serving as an employee of Inisghtec Europe GmbH.
Katie Gant	Katie Gant has received personal compensation for serving as an employee of Insightec .
Augusto Grinspan, MD (Acorda Therapeutics, Inc.)	Dr. Grinspan has received personal compensation for serving as an employee of Insightec.

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