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Parkinson's DiseaseNCT02263885

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

A study testing ExAblate Transcranial System in people with Parkinson's Disease, run by InSightec at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson's Disease
What is being tested?
ExAblate Transcranial System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
5 sitesUnited States
Study dates
Apr 2015to 26 Jul 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 30Show fewer
  • 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
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Maryland Medical System

    Baltimore, Maryland, 21201

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • University of Virginia

    Charlottesville, Virginia, 22908

  • The Ohio State Wexner Medical Center

    Columbus, Ohio, 43210

  • Stanford University Medical Center

    Stanford, California, 94305

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
ExAblate Transcranial System
Keywords
Parkinson's Disease, ExAblate, MRgFUS
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExAblate Transcranial SystemDevice

    Also called MRgFUS, FUS, Focused Ultrasound, MR Guided Focused Ultrasound

    Transcranial MRgFUS

Study groups in NCT02263885
Study groupRoleWhat they receive
ExAblate Transcranial SystemExperimentalTranscranial ExAblate MRgFUS
Receives: Device: ExAblate Transcranial System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Month 24

Secondary outcomes (5)

  1. 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.

    Measured: Screening, Month 3, Month 6, Month 12, Month 24

  2. 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.

    Measured: Screening, Month 3, Month 6, Month 12, Month 24

  3. 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.

    Measured: Screening, Month 3, Month 6, Month 12, Month 24

  4. 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.

    Measured: Screening, Month 3, Month 6, Month 12, Month 24

  5. 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.

    Measured: Screening, Month 3, Month 6, Month 12, Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2014 (estimated)
  2. Study startApr 2015
  3. Primary completion15 May 2019
  4. Study completion26 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02263885
Sponsor's protocol ID
PD002
Status last verified
Dec 2021
First submitted
8 Oct 2014
Last updated
19 Jan 2022
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33481557

Questions about this trial

What is this clinical trial studying?

A study testing ExAblate Transcranial System in people with Parkinson's Disease, run by InSightec at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Month 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02263885, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.

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