A Clinical Trial for the Safety and Effect of MRGuided FUS Subthalamotomy for Medication Refractory Parkinson's Disease

NCT04744493 | Completed

• 1 other identifier: PD003J
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Study design: This is a prospective, open-label, single-center, and sponsor-initiated clinical trial. The clinical trial follows the Clinical Investigation Plan, GCP. Objective: The objective of the clinical trial is to evaluate improving Parkinson's disease motor features by MR-guided focused ultrasound surgery (Patient who has less effectiveness.).

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence and severity of adverse events (AE/AEs) associated with PD003J treatment of idiopathic PD from baseline until 4 months post treatment.

  The primary safety outcome including incidence and severity of adverse events (AE/AEs) will be assessed at 4 months. The severity of any adverse events that will be reported by patients or that will be observed during the procedure or at 4 months post treatment will be assessed. A complication or worsening of a preexisting clinical condition after the procedure will be considered to be an adverse event regardless of causality.

  Comfirmation from baseline until 4 months post treatment

Secondary Outcomes (4)

• Secondary endpoints will include MDS-UPDRS parts I, II, III, and IV at baseline, 1 week, 2 months, and 4 months post treatment.

  Comparison between baseline, 1 week, 2 months, and 4 months post treatment.

• Levodopa equivalent medication usage (milligrams).

  Comparison between baseline, 1 week, 2 months, and 4 months post treatment.

• Patient and clinician Global Impression Rating Scale.

  Comparison between baseline, 1 week, 2 months, and 4 months post treatment.

• Patient Satisfaction Questionnaire.

  Comparison between baseline, 1 week, 2 months, and 4 months post treatment.

Study Arms (1)

treatment arm of Exablate 4000 as a single arm

EXPERIMENTAL

Only one arm of treatment by Exablate 4000 was established.

Device: ExaBlate 4000

Interventions

ExaBlate 4000 DEVICE

The Exablate 4000, an advanced, non-invasive technique for performing ablation of the Thalamus for treating Essential Tremor, received FDA PMA (P150038) approval for unilateral treatment of Essential Tremor in 2016.

treatment arm of Exablate 4000 as a single arm

Eligibility Criteria

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

You may qualify if:

• Men and women, age 30 years and older
• Subjects who are able and willing to give informed consent and able to attend all study visits through 4 Months
• Subjects with a diagnosis of Parkinson's Disease using the MDS criteria as confirmed by a movement disorder neurologist at the site
• Predominant disability from one side of the body (i.e. unilateral or markedly asymmetric disease) as determined by a movement disorders neurologist
• Subjects should be on a stable dose of all PD medications for 30 days prior to study entry.
• Topographic coordinates of the subthalamic nucleus are localizable on MRI so that it can be targeted by the PD003J.
• Subject is able to communicate sensations during the PD003J procedure.
• Subject cannot obtain with drugs for treating Parkinson's disease.

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)
• 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
• Subjects with significant depression as determined following a comprehensive assessment. Significant depression is being defined quantitatively as a score of greater than 19 on the Beck Depression Inventory.
• 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).
• Subjects with unstable cardiac status including:
• Unstable angina pectoris on medication

Sponsors & Collaborators

• InSightec: lead

Study Sites (1)

Osaka University Hospital

Suita, Osaka, 5650871, Japan

Location

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 Design

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

Model Details: This is a prospective, open-label, single-center, and sponsor-initiated clinical trial. The clinical trial follows the Clinical Investigation Plan, GCP.

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: February 9, 2021
• Study Start: May 31, 2019
• Primary Completion: May 31, 2022
• Study Completion: July 31, 2022
• Last Updated: March 6, 2024

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)