ExAblate Transcranial MRgFUS of the Subthalamic Nucleus for Treatment of Parkinson's Disease

NCT02246374 | Completed DMC

• 1 other identifier: PD003
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is primarily a safety protocol to evaluate the safety of subthalamotomy using Transcranial ExAblate for treatment of Parkinson's Disease (PD) motor features.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; ExAblate; MRgFUS

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of adverse events

  Safety will evaluate the incidence and severity of adverse events associated with ExAblate subthalamotomy for the treatment of Parkinson's Disease motor features.

  Baseline to 4 months post treatment

• Mean change in MDS-UPDRS Part III scores

  This is a feasibility trial with no hypothesis testing. Primary efficacy will be evaluated using basic summary statistics including comparison of between- and within-group differences in the mean change (from baseline to 4 months) of the motor MDS-UPDRS Part III score for the side contralateral to subthalamotomy in the off-medication condition.

  Baseline to 4 months post treatment

Secondary Outcomes (1)

• Long Term Adverse Events Profile

  Baseline to 12- months post treatment

Other Outcomes (2)

• Mean change in MDS-UPDRS total score

  Baseline to 12- months post treatment

• Mean change in MDS-UPDRS Part IV scores

  Baseline to 12-months post treatment

Study Arms (2)

ExAblate Treated Arm

EXPERIMENTAL

ExAblate Transcranial System subthalamotomy for motor symptoms of Parkinson's Disease.

Device: ExAblate Transcranial System

ExAblate Sham Treated Arm

SHAM COMPARATOR

ExAblate Transcranial System sham subthalamotomy for motor symptoms of Parkinson's Disease. Sham subjects completing the 4 Month visit may be offered the actual ExAblate subthalamotomy.

Device: ExAblate Transcranial System

Interventions

ExAblate Transcranial System DEVICE

ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease

Also known as: MRgFUS, FUS, Focused Ultrasound, MR Guided Focused Ultrasound

ExAblate Sham Treated Arm; ExAblate Treated 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
• Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site
• Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor sub-scale in the ON vs OFF medication state
• Disabling motor clinical features not optimally controlled by an adequate medication prescription. An adequate medication prescription is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated
• Predominant disability from one side of the body (i.e unilateral or markedly asymmetric disease) as determined by movement disorders neurologist and neurosurgeon
• Subjects should be on a stable dose of all PD medications for 30 days prior to study entry
• Subthalamic nucleus is visible on MRI so that it can be targeted by the ExAblate device
• Subjects should have a Screening motor assessment of ≥ 35 while OFF medications on the MDS-UPDRS
• Subject is able to communicate sensations during the ExAblate Transcranial procedure

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
• 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)
• Subjects with unstable cardiac status including:

Sponsors & Collaborators

• InSightec: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

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

• Jeff Elias, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 22, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2021
• Study Completion: May 18, 2021
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)