NCT02263885

Brief Summary

The proposed study will evaluate the safety, and initial efficacy of using the ExAblate Transcranial to create a unilateral lesion in the globus pallidus as an adjunct to PD medications in subjects who are over 30 years of age and considered medication-refractory with advanced idiopathic Parkinson's disease (PD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2019

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

January 19, 2022

Completed
Last Updated

January 19, 2022

Status Verified

December 1, 2021

Enrollment Period

4.1 years

First QC Date

October 8, 2014

Results QC Date

September 7, 2021

Last Update Submit

December 20, 2021

Conditions

Parkinson's Disease

Keywords

Parkinson's DiseaseExAblateMRgFUS

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    The primary outcome of this feasibility trial was safety. Adverse Events were categorized by physicians as mild, moderate, or severe. Events resulting in impairment, requiring intervention to preclude impairment, or that were life threatening, and deaths were reported by physicians as Serious Adverse Events. Outcomes are entered in the adverse events module.

    Month 24

Secondary Outcomes (5)

  • Unified Dyskinesia Rating Scale Total Score.

    Screening, Month 3, Month 6, Month 12, Month 24

  • Unified Dyskinesia Rating Scale (UDysRS), Part III

    Screening, Month 3, Month 6, Month 12, Month 24

  • Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III Motor Exam

    Screening, Month 3, Month 6, Month 12, Month 24

  • Mood Disorders Society - Unified Parkinson's Disease Rating Scale Part II

    Screening, Month 3, Month 6, Month 12, Month 24

  • Mood Disorder Society Unified Parkinson's Disease Rating Scale Part IV

    Screening, Month 3, Month 6, Month 12, Month 24

Study Arms (1)

ExAblate Transcranial System

EXPERIMENTAL

Transcranial ExAblate MRgFUS

Device: ExAblate Transcranial System

Interventions

ExAblate Transcranial SystemDEVICE

Transcranial MRgFUS

Also known as: MRgFUS, FUS, Focused Ultrasound, MR Guided Focused Ultrasound
ExAblate Transcranial System

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 24 Months
  • Subjects with a diagnosis of idiopathic PD
  • Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor subscale in the ON vs OFF medication state.
  • Disabling motor complications of PD on optimum medical treatment
  • 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.
  • Subject is able to communicate sensations during the ExAblate Transcranial procedure.

You may not qualify if:

  • 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
  • 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.
  • Legal incapacity or limited legal capacity as determined by the neuropsychologist
  • Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
  • 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
  • Severe hypertension (diastolic BP \> 100 on medication)
  • Current medical condition resulting in abnormal bleeding and/or coagulopathy
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

University of Maryland Medical System

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

The Ohio State Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • Eisenberg HM, Krishna V, Elias WJ, Cosgrove GR, Gandhi D, Aldrich CE, Fishman PS. MR-guided focused ultrasound pallidotomy for Parkinson's disease: safety and feasibility. J Neurosurg. 2020 Nov 27;135(3):792-798. doi: 10.3171/2020.6.JNS192773. Print 2021 Sep 1.

    PMID: 33481557DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Limitations and Caveats

This is a single-arm, open label, feasibility trial. Analyses included basic descriptive statistics. No hypothesis testing was proposed.

Results Point of Contact

Title
Nadir Alikacem, PhD
Organization
InSightec
nadira@insightec.com
214-630-2000

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

October 8, 2014

First Posted

October 13, 2014

Study Start

April 1, 2015

Primary Completion

May 15, 2019

Study Completion

July 26, 2019

Last Updated

January 19, 2022

Results First Posted

January 19, 2022

Record last verified: 2021-12

Locations

US(5)