A Prospective, Randomized, Controlled Trial to Test Safety and Effectiveness of Unilateral Exablate MR-guided Focused Ultrasound Subthalamotomy in Patients With Early-Stage Parkinson's Disease
NCT Number: NCT06584383
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease
Interventions: PROCEDURE: Exablate MRgFUS subthalamotomy|DRUG: Best Medical Treatment
Sponsor: InSightec
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2029-09
Locations: HM CINAC- Hospital Universitario HM Puerta del Sur, Móstoles, 28938, Spain

Summary:
This prospective, randomized, multicenter study aims to evaluate in Early-Stage Parkinson's Disease (ESPD) patients the safety and effectiveness of treatment with Exablate MRgFUS subthalamotomy vs best medical treatment.

Primary Outcome Measures: MDS-UPDRS Part III OFF Medication, Between-group difference in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III at 12 months in the off-medication state., 12 Months
Secondary Outcome Measures: PD-specific spatial covariance patterns (PDRP or PD related metabolic pattern) with brain 18F-fluorodeoxyglucose- Positron emission tomography, The metabolic pattern will be quantified to obtain a PDRP expression scores at baseline, 12-month and to compare disease evolution between groups., 12 Months|MDS-UPDRS III OFF-med video-based evaluation, Between group comparison through month 12 and within group comparison vs baseline month 12 in MDS-UPDRS III OFF-med video-based evaluation by a blinded movement disorders neurologist (only at baseline and 12 months)., 12 Months|MDS-UPDRS I, II, III (ON and OFF meds) and UPDRS IV, Between group comparison through month 12 and within group comparison vs baseline month 12 to 36 in MDS-UPDRS I, II, III (ON and OFF meds) and UPDRS IV, 12 Months, 24 Months, 36 Months|MDS Unified Dyskinesia Rating Scale, Between group comparison through month 12 and within group comparison vs baseline month 12 to 36 in MDS Unified Dyskinesia Rating Scale, 12 Months, 24 Months, 36 Months|Quality of life assessment (PDQ39), Between group comparison through month 12 and within group comparison vs baseline month 12 to 36 in Quality-of-life assessment (PDQ39), 12 Months, 24 Months, 36 Months|Medication change, Between group comparison through month 12 and within group comparison vs baseline month 12 to 36 in Parkinson's Disease medication change, 12 Months, 24 Months, 36 Months|MDS-Non motor rating scale, Between group comparison through month 12 and within group comparison vs baseline month 12 to 36 in MDS-Non motor rating scale, 12 Months, 24 Months, 36 Months|Patient Global Impression of Change (PGIC), Between group comparison through month 12 and within group comparison vs baseline month 12 to 30 in Patient Global Impression of Change (PGIC), 12 Months, 24 Months, 36 Months|Clinician Global Impression of Change (CGIC), Between group comparison through month 12 and within group comparison vs baseline month 12 to 30 in Clinician Global Impression of Change (PGIC), 12 Months, 24 Months, 36 Months
Other Outcome Measures: Safety: Incidence and frequency of adverse events related to the treatment., Incidence and frequency of adverse events related to the treatment. The investigator will capture any untoward events related to the treatment in the case report forms along with severity, duration, and resolution, and whether the event is considered serious. The severity of adverse events will be categorized according to the definition of adverse events from the International Organization for Standardization (ISO)., 36 Months|Exploratory assessment: F- Dopa PET assessment, F- Dopa PET assessment will evaluate difference in the progression of striatal dopaminergic denervation., 12 Months, 36 Months|Exploratory assessment: Time to Parkinson's Disease Progression, PD progression will also be defined by comparing between-group Kaplan-Meier curves of subjects exceeding the worsening thresholds of specific clinical scales, 12 Months, 24 Months, 36 Months