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Parkinson DiseaseEarlyFocusNCT04692116

Parkinson's Disease (PD) Treated With Focused Ultrasound Subthalamotomy at an Early Stage

A study testing ExAblate treatment in people with Parkinson Disease, run by Fundación de investigación HM at 1 site in Spain.

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

Parkinson's disease (PD) is a common, progressive, incurable neurodegenerative disease that can result in severe disability and impairment in health-related quality of life. Current medical and surgical therapies are aimed toward maximal symptom relief with minimal associated side effects or morbidity. Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Parkinson Disease
What is being tested?
ExAblate treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSpain
Study dates
25 Nov 2020to 12 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 30-65 years old.
  • Subjects who are able and willing to give consent and able to attend all study visits.
  • Diagnosis of PD according to UK (United Kingdom) Brain Bank Criteria as confirmed by movement disorder neurologist at our centre.
  • Less than 5 years since first PD diagnosis.
  • F-dopa PET (Positron Emission Tomography) pattern of striatal dopaminergic denervation suggestive of Parkinson's disease (rostro-caudal gradient).
  • Stable pharmacological regime for the 4-weeks prior to procedure.
  • Topographic coordinates of the subthalamic nucleus are localizable on MRI (Magentic Resonance Imaging) so that it can be targeted by the ExAblate device.
  • Able to communicate sensations during the ExAblate MRgFUS treatment.

Who cannot join

  • 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.
Show all 39Show fewer
  • Patients without clinically relevant parkinsonism in the off-state as evaluated by two examining neurologists. (or MDS-UPDRS in the most affected side <10).
  • 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:
  • 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).
  • History of or 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 <30mL/min/1.73m 2 (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.
  • Subject who weight more than the upper weight limit of the MR table and who cannot fit into the MR scanner
  • 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 malignant brain tumors
  • Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment.
  • 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.
  • Subjects who have an Overall Skull Density Ratio lower than 0.42 as calculated from the screening CT.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario HM Puerta del Sur

    Móstoles, Madrid, 28938

Other trials in Spain

About this study

Official title: EarlyFocus I: A Single Center Study on the Short-term Safety of Parkinson's Disease (PD) Treated With Focused Ultrasound Subthalamotomy at an Early Stage (<5 Years From the Diagnosis).

Parkinson's disease (PD) is a common, progressive, incurable neurodegenerative disease that can result in severe disability and impairment in health-related quality of life. Current medical and surgical therapies are aimed toward maximal symptom relief with minimal associated side effects or morbidity. It is generally accepted that a well-placed stereotactic lesion is comparable in its magnitude of clinical effect to the high frequency electrical stimulation of the same target.

Exablate Neuro is intended to treat movement disorders with unilateral ablation of targets in the thalamus, subthalamic nucleus and globus pallidus nuclei.

With the ExAblate system, transcranial high-intensity focused ultrasound has been coupled with high resolution MRI to provide precise, consistent treatments that can be monitored throughout the procedures.

Being tested
ExAblate treatment
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 treatmentDevice

    Subthalamotomy using the ExAblate

Study groups in NCT04692116
Study groupRoleWhat they receive
ExAblate ArmExperimentalExAblate Model 4000 System for the treatment of Parkinson's disease
Receives: Device: ExAblate treatment

What is being measured

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

  1. Incidence of Adverse Events (AEs) associated with ExAblate

    Incidence of Adverse Events (AEs) associated with ExAblate

    Measured: Month 6 after the subthalamotomy

  2. Severity of Adverse Events (AEs) associated with ExAblate

    Severity of Adverse Events (AEs) associated with ExAblate

    Measured: Month 6 after the subthalamotomy

Secondary outcomes (8)

  1. Mean change in the motor MDS-UPDRS

    Mean change in the motor MDS-UPDRS (Movement Disorder Scale-Unified Parkinson's Disease Rating Scale) score in both off- and on-medication conditions (when applicable) for both the treated body side and the total motor score.

    [Lowest score = 0; Highest score = 52; Best outcome = lower score]

    Measured: Month 3 and 6 after the subthalamotomy

  2. Mean change in specific PD motor features

    Mean change in specific PD motor features of the treated body side (i.e., tremor, rigidity and akinesia according to MDS-UPDRS III subscores [Movement Disorder Scale-Unified Parkinson's Disease Rating Scale III].

    Measured: Month 3 and 6 after the subthalamotomy

  3. MDS-UPDRS I score [Movement Disorder Scale-Unified Parkinson's Disease Rating Scale I]

    Lowest score = 0; Highest score = 52; Best outcome = lower score

    Measured: Month 3 and 6 after the subthalamotomy

  4. MDS-UPDRS II score [Movement Disorder Scale-Unified Parkinson's Disease Rating Scale II]

    Lowest score = 0; Highest score = 52; Best outcome = lower score

    Measured: Month 3 and 6 after the subthalamotomy

  5. UPDRS IV score [Unified Parkinson's Disease Rating Scale IV]

    Lowest score = 0; Highest score = 24; Best outcome = lower score

    Measured: Month 3 and 6 after the subthalamotomy

  6. MDS-Non motor rating scale [Movement Disorder Scale]

    Lowest score = 0; Highest score = 52; Best outcome = lower score

    Measured: Month 3 and 6 after the subthalamotomy

  7. Quality of life assessment (QoL)

    Assessment of QoL by using the instrument PDQ39

    Measured: Month 3 and 6 after the subthalamotomy

  8. Levodopa equivalent dose change usage

    Levodopa equivalent dose change usage (milligrams) when applicable

    Measured: Month 3 and 6 after the subthalamotomy

Timeline

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

  1. First posted31 Dec 2020
  2. Study start25 Nov 2020
  3. Primary completion12 Nov 2021
  4. Study completion12 Nov 2021

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
Model description
Single-site open clinical investigation
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04692116
Sponsor's protocol ID
PD020
Acronym
EarlyFocus
Status last verified
Jun 2022
First submitted
30 Dec 2020
Last updated
7 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Martinez Fernandez R, Natera Villalba E, Rodriguez-Rojas R, Del Alamo M, Pineda-Pardo JA, Obeso I, Mata-Marin D, Guida P, Jimenez-Castellanos T, Perez-Bueno D, Duque A, Manez Miro JU, Gasca-Salas C, Matarazzo M, Obeso JA. Unilateral focused ultrasound subthalamotomy in early Parkinson's disease: a pilot study. J Neurol Neurosurg Psychiatry. 2024 Feb 14;95(3):206-213. doi: 10.1136/jnnp-2023-331211.

    PubMed 37673642

Questions about this trial

What is this clinical trial studying?

A study testing ExAblate treatment in people with Parkinson Disease, run by Fundación de investigación HM at 1 site in Spain.

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 39 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 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of Adverse Events (AEs) associated with ExAblate (time frame: Month 6 after the subthalamotomy). The study lists 2 primary outcomes in all. 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 NCT04692116, 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 7 Jun 2022.

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