Parkinson's Disease (PD) Treated With Focused Ultrasound Subthalamotomy at an Early Stage

NCT04692116 | Completed

• 1 other identifier: PD020
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease (PD) is a common, progressive, incurable neurodegenerative disease that can result in severe disability and impairment in health-related quality of life. Current medical and surgical therapies are aimed toward maximal symptom relief with minimal associated side effects or morbidity. It is generally accepted that a well-placed stereotactic lesion is comparable in its magnitude of clinical effect to the high frequency electrical stimulation of the same target. Exablate Neuro is intended to treat movement disorders with unilateral ablation of targets in the thalamus, subthalamic nucleus and globus pallidus nuclei. With the ExAblate system, transcranial high-intensity focused ultrasound has been coupled with high resolution MRI to provide precise, consistent treatments that can be monitored throughout the procedures.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events (AEs) associated with ExAblate

  Incidence of Adverse Events (AEs) associated with ExAblate

  Month 6 after the subthalamotomy

• Severity of Adverse Events (AEs) associated with ExAblate

  Severity of Adverse Events (AEs) associated with ExAblate

  Month 6 after the subthalamotomy

Secondary Outcomes (8)

• Mean change in the motor MDS-UPDRS

  Month 3 and 6 after the subthalamotomy

• Mean change in specific PD motor features

  Month 3 and 6 after the subthalamotomy

• MDS-UPDRS I score [Movement Disorder Scale-Unified Parkinson's Disease Rating Scale I]

  Month 3 and 6 after the subthalamotomy

• MDS-UPDRS II score [Movement Disorder Scale-Unified Parkinson's Disease Rating Scale II]

  Month 3 and 6 after the subthalamotomy

• UPDRS IV score [Unified Parkinson's Disease Rating Scale IV]

  Month 3 and 6 after the subthalamotomy

Study Arms (1)

ExAblate Arm

EXPERIMENTAL

ExAblate Model 4000 System for the treatment of Parkinson's disease

Device: ExAblate treatment

Interventions

ExAblate treatment DEVICE

Subthalamotomy using the ExAblate

ExAblate Arm

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30-65 years old.
• Subjects who are able and willing to give consent and able to attend all study visits.
• Diagnosis of PD according to UK (United Kingdom) Brain Bank Criteria as confirmed by movement disorder neurologist at our centre.
• Less than 5 years since first PD diagnosis.
• F-dopa PET (Positron Emission Tomography) pattern of striatal dopaminergic denervation suggestive of Parkinson's disease (rostro-caudal gradient).
• Stable pharmacological regime for the 4-weeks prior to procedure.
• Topographic coordinates of the subthalamic nucleus are localizable on MRI (Magentic Resonance Imaging) so that it can be targeted by the ExAblate device.
• Able to communicate sensations during the ExAblate MRgFUS treatment.

You may not qualify if:

• Hoehn and Yahr stage in the ON medication state of 2.5 or greater
• Presence of severe dyskinesia as noted by a score of 3 or 4 on questions 4.1 and 4.2 of the MDS-UPDRS.
• Presence of other central neurodegenerative disease suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, and Alzheimer's disease.
• Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
• Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
• Presence of significant cognitive impairment defined as score ≤ 21 on the Montreal Cognitive Assessment (MoCA) or Mattis Dementia Rating Scale of 120 or lower.
• Patients without clinically relevant parkinsonism in the off-state as evaluated by two examining neurologists. (or MDS-UPDRS in the most affected side \<10).
• Unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation. Subjects with stable, chronic anxiety or depressive disorders may be included provided their medications have been stable for at least 60 days prior to study entry and if deemed appropriately managed by the site neuropsychologist
• Subjects with significant depression as determined following a comprehensive assessment by a neuropsychologist. Significant depression is being defined quantitatively as a score of greater than 14 on the Beck Depression Inventory.
• Legal incapacity or limited legal capacity as determined by the neuropsychologist
• Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within the preceding 12-month period:
• Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household).
• Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use)
• Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct)
• Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights).

Sponsors & Collaborators

• Fundación de investigación HM: lead
• Syntax for Science, S.L: collaborator

Study Sites (1)

Hospital Universitario HM Puerta del Sur

Móstoles, Madrid, 28938, Spain

Location

Related Publications (1)

• Martinez Fernandez R, Natera Villalba E, Rodriguez-Rojas R, Del Alamo M, Pineda-Pardo JA, Obeso I, Mata-Marin D, Guida P, Jimenez-Castellanos T, Perez-Bueno D, Duque A, Manez Miro JU, Gasca-Salas C, Matarazzo M, Obeso JA. Unilateral focused ultrasound subthalamotomy in early Parkinson's disease: a pilot study. J Neurol Neurosurg Psychiatry. 2024 Feb 14;95(3):206-213. doi: 10.1136/jnnp-2023-331211.

  PMID: 37673642 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• José Obeso, MD

  Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-site open clinical investigation

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: December 31, 2020
• Study Start: November 25, 2020
• Primary Completion: November 12, 2021
• Study Completion: November 12, 2021
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)