Safety and Initial Effectiveness of Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease

NCT04002596 | Completed DMC

• 1 other identifier: PD001J
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Safety and Effectiveness in ExAblate Neuro treatment of medication-refractory tremor in subjects with idiopathic Parkinson's disease.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Clinical Rating Scale for Tremor

  Primary effectiveness will be a comparison of the CRST scores at baseline vs. 3 months. (Range 0-152, scores are combined, the higher the score, the greater the clinical level of tremor, the worse clinical outcome is)

  3 Months after Treatment

• Severity of Device and Procedure related complications

  To evaluate the incidence and severity of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor dominant PD after the ExAblate treatment and during the follow-up period of up up to 1 year

  1 year

Secondary Outcomes (3)

• Clinical Rating Scale for Tremor, Total Score

  1 year

• Clinical Rating Scale for Tremor, Part C

  1 year

• Parkinson's Disease Questionnaire - 39

  1 year

Study Arms (1)

ExAblate MRgFUS treatment

EXPERIMENTAL

Ablation of Thalamus Vim nucleus with ExAblate 4000 Neuro MRgFUS for TDPD

Device: ExAblate Neuro Thalamotomy Treatment

Interventions

ExAblate Neuro Thalamotomy Treatment DEVICE

Non-invasive Focused Ultrasound Ablation of Thalamus Vim nucleus using ExAblate MRgFUS system for treatment Tremor Dominant Parkinson Disease

Also known as: MRgFUS Vim ablation, Non-invasive Focused Ultrasound Ablation of Thalamus Vim nucleus

ExAblate MRgFUS treatment

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 3 Months
• Subjects with a diagnosis of idiopathic PD as confirmed from clinical history and examination by a movement disorder neurologist at the site
• All subjects included in this study will have a TD/PIGD ratio \> 1.15 in the medicated \[ON\] state as calculated from the UPDRS formula as described by S, et. al., \[74\].
• Note: Ratios for TD/PIGD that are greater than or equal to 1.15 are defined as TDPD. PIGD includes those with a ratio of less than or equal to 0.9. Scores of greater than 0.9 and less than 1.15 are considered a mixed subtype.
• Subject demonstrates a resting tremor severity score of greater than or equal to 3 in the hand/arm as measured by the medicated (ON) MDS-UPDRS question 3.17 or a postural/action tremor greater than or equal to a 2 for question 3.15 or 3.16.
• Significant disability due to PD tremor despite medical treatment (CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: \[speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities\])
• Tremor remains disabling when medical therapy is optimal or not tolerated for the treatment of other cardinal signs of PD (bradykinesia, rigidity, etc), as determined by a movement disorders neurologist at the site
• Subjects should be on a stable dose of all PD medications for 30 days prior to study entry.
• The thalamus must be apparent on MRI such that targeting of the Vim nucleus can be performed indirectly by measurement from a line connecting the anterior and posterior commissures of the brain.
• Subject is able to communicate sensations during the ExAblate Transcranial procedure.

You may not qualify if:

• Subjects with unstable cardiac status including:
• Unstable angina pectoris on medication
• Subjects with documented myocardial infarction within six months of protocol entry
• Significant congestive heart failure defined with ejection fraction \< 40
• Subjects with unstable ventricular arrhythmias
• Subjects with atrial arrhythmias that are not rate-controlled
• 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).
• Severe hypertension (diastolic BP \> 100 on medication)
• Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
• Significant claustrophobia that cannot be managed with mild medication.
• Current medical condition resulting in abnormal bleeding and/or coagulopathy

Sponsors & Collaborators

• InSightec: lead

Study Sites (1)

Shonan Fujisawa Tokushukai Hospital

Fujisawa, Kanagawa, 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 Officials

• Martin Bernstein

  InSightec

  STUDY DIRECTOR

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: ExAblate Neuro Treatment Group

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: June 28, 2019
• Study Start: February 6, 2017
• Primary Completion: December 5, 2018
• Study Completion: September 4, 2019
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)