ExAblate Transcranial MRgFUS of the Globus Pallidum for Treatment of Parkinson's Disease

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ExAblate Transcranial System

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, ExAblate, MRgFUS

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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:
1. Unstable angina pectoris on medication
2. Subjects with documented myocardial infarction within six months of protocol entry
3. Significant congestive heart failure defined with ejection fraction < 40
4. Subjects with unstable ventricular arrhythmias
5. 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
Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure
Subjects with risk factors for intraoperative or postoperative bleeding as indicated by: platelet count less than 100,000 per cubic millimeter, a documented clinical coagulopathy, or INR coagulation studies exceeding the institution's laboratory standard
Patient with severely impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2 (or per local standards should that be more restrictive) and/or who is on dialysis;
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.
Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment.
History of intracranial hemorrhage
History of multiple strokes, or a stroke within past 6 months
Subjects with a history of seizures within the past year
Subjects with brain tumors
Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment.
Are participating or have participated in another clinical trial in the last 30 days
Any illness that in the investigator's opinion preclude participation in this study.
Subjects unable to communicate with the investigator and staff.
Pregnancy or lactation.

Sites / Locations

Stanford University Medical Center
University of Maryland Medical System
Brigham and Women's Hospital
The Ohio State Wexner Medical Center
University of Virginia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ExAblate Transcranial System

Arm Description

Transcranial ExAblate MRgFUS

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Unified Dyskinesia Rating Scale Total Score.

The Unified Dyskinesia Rating Scale Total score assesses overall involuntary movements associated with the treatment of Parkinson's disease. The minimum score possible is 0. The maximum total score possible is 104. High scores show worse symptoms.

Unified Dyskinesia Rating Scale (UDysRS), Part III

The Unified Dyskinesia Ratient Scale (UDysRS) was developed to assess involuntary movements often associated with the treatment of Parkinson's disease. Part III evaluates the intensity of impairment of dyskinesia with respect to the performance of 7 tasks on a scale of 0 to 4. The sum of the Part III score ranges 0 to 28 and high scores show worse symptoms.

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

The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS UPDRSP Part III motor exam focuses specifically on the treated side tremor and motor fluctuations. Each of 11 items are scored from 0 to 4 for a total score minimum of 0 and a maximum of 44 points. High scores show worse symptoms.

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

.Part II of the Mood Disorders Society Unified Parkinson's Disease Rating Scale focuses on the impact of symptoms on motor aspects of daily living. Part II consists of 13 items scored from 0 to 4 for a maximum score of 52. High Part II scores indicate worse (greater) impact.

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

Part IV of the Mood Disorder Society Unified Parkinson's Disease Rating Scale assesses dyskinesias that include OFF-state dystonia; items include time spent with dyskinesia, functional impact of dyskinesia, time spent in the OFF state, functional impact of fluctuations, complexity of motor fluctuations and painful OFF state dystonia. Six items are scored 0 to 4 with a maximum total score of 24. High scores indicate worse symptoms.

Full Information

NCT ID

NCT02263885

First Posted

October 8, 2014

Last Updated

December 20, 2021

Sponsor

InSightec

1. Study Identification

Unique Protocol Identification Number

NCT02263885

Brief Title

ExAblate Transcranial MRgFUS of the Globus Pallidum for Treatment of Parkinson's Disease

Official Title

A Feasibility Clinical Trial of the Management of the Medically-Refractory Dyskinesia Symptoms of Advanced Idiopathic Parkinson's Disease With Unilateral Lesioning of the Globus Pallidum Using the ExAblate Transcranial System

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

May 15, 2019 (Actual)

Study Completion Date

July 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InSightec

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

The purpose of this study is to evaluate the safety and initial clinical effectiveness of ExAblate Transcranial unilateral thermal ablation of the globus pallidus of subjects suffering from medication-refractory, advanced idiopathic PD. Data will be collected to establish the basic safety and clinical efficacy of this type of treatment as the basis for later studies that will evaluate the full clinical efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

Keywords

Parkinson's Disease, ExAblate, MRgFUS

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ExAblate Transcranial System

Arm Type

Experimental

Arm Description

Transcranial ExAblate MRgFUS

Intervention Type

Device

Intervention Name(s)

ExAblate Transcranial System

Other Intervention Name(s)

MRgFUS, FUS, Focused Ultrasound, MR Guided Focused Ultrasound

Intervention Description

Transcranial MRgFUS

Primary Outcome Measure Information:

Title

Adverse Events

Description

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.

Time Frame

Month 24

Secondary Outcome Measure Information:

Title

Unified Dyskinesia Rating Scale Total Score.

Description

The Unified Dyskinesia Rating Scale Total score assesses overall involuntary movements associated with the treatment of Parkinson's disease. The minimum score possible is 0. The maximum total score possible is 104. High scores show worse symptoms.

Time Frame