Staged, Bilateral MR-guided Focused Ultrasound Pallidothalamic Tractotomy as a Treatment for Movement Disorders: Rationale and Design of a Parkinson’s Disease Study
Arif Dalvi1, Lloyd Zucker2, Wei Chieh Chang3, Peihan Wu4, Michael Kaplitt5, Harini Sarva6, Howard Eisenberg7, Paul Fishman8, Vivek Buch9, Michele Matarazzo10, Marta del Alamo10, Lain Hermes Gonzalez-Quarante11, Maria Cruz Rodriguez-Oroz11, Sepehr Sani12, Michael Pourfar13, Alon Mogilner14, Gaganjot Sooch15, Cyril Ferrer15, Katie Gant15, Augusto Grinspan15
1Comprehensive Movement Disorders Center, Palm Beach Neuroscience Institute, 2Brain and Spine Center South Florida, 3Neurosurgery, 4Neurology, Chang Bing Show Chwan Memorial Hospital, 5Neurosurgery, 6Neurology, Weill Cornell Medicine, 7Neurosurgery, University of Maryland, 8Univ of Maryland Sch of Med, 9Neurosurgery, Stanford University, 10HM CINAC, 11Clinica Universidad de Navarra, 12Neurosurgery, Rush University Medical Center, 13Neurology, 14Neurosurgery, NYU Langone Health, 15Insightec
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.
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