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Parkinson DiseaseTDPDNCT04002596

Safety and Initial Effectiveness of Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease

A study testing ExAblate Neuro Thalamotomy Treatment in people with Parkinson Disease, run by InSightec at 2 sites in 2 countries.

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

Safety and Effectiveness in ExAblate Neuro treatment of medication-refractory tremor in subjects with idiopathic Parkinson's disease. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
ExAblate Neuro Thalamotomy Treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
2 sitesin 2 countries
Study dates
6 Feb 2017to 15 Jan 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 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 3 Months
  • Subjects with a diagnosis of idiopathic PD as confirmed from clinical history and examination by a movement disorder neurologist at the site
  • All subjects included in this study will have a TD/PIGD ratio > 1.15 in the medicated [ON] state as calculated from the UPDRS formula as described by S, et. al., [74].
  • Note: Ratios for TD/PIGD that are greater than or equal to 1.15 are defined as TDPD. PIGD includes those with a ratio of less than or equal to 0.9. Scores of greater than 0.9 and less than 1.15 are considered a mixed subtype.
  • Subject demonstrates a resting tremor severity score of greater than or equal to 3 in the hand/arm as measured by the medicated (ON) MDS-UPDRS question 3.17 or a postural/action tremor greater than or equal to a 2 for question 3.15 or 3.16.
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  • Significant disability due to PD tremor despite medical treatment (CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: [speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities])
  • Tremor remains disabling when medical therapy is optimal or not tolerated for the treatment of other cardinal signs of PD (bradykinesia, rigidity, etc), as determined by a movement disorders neurologist at the site
  • Subjects should be on a stable dose of all PD medications for 30 days prior to study entry.
  • The thalamus must be apparent on MRI such that targeting of the Vim nucleus can be performed indirectly by measurement from a line connecting the anterior and posterior commissures of the brain.
  • Subject is able to communicate sensations during the ExAblate Transcranial procedure.

Who cannot join

  • 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
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  • 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).
  • Severe hypertension (diastolic BP > 100 on medication)
  • 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.
  • Current medical condition resulting in abnormal bleeding and/or coagulopathy
  • 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;
  • 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
  • History of intracranial hemorrhage
  • History of multiple strokes, or a stroke within past 6 months
  • Subject who weigh more than the upper weight limit of the table or subjects who will not fit into the MR scanner
  • Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment.
  • Are participating or have participated in another clinical trial in the last 30 days
  • Subjects unable to communicate with the investigator and staff.
  • Presence of central neurodegenerative disease, including but not limited to Parkinson-plus syndromes, 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.
  • Presence of significant cognitive impairment as determined with a score ≤ 24 on the Mini Mental Status Examination (MMSE)
  • 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 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.
  • Any illness that in the investigator's opinion preclude participation in this study.
  • Pregnancy or lactation.
  • Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
  • Subjects with remarkable atrophy and poor healing capacity of the scalp (> 30% of the skull area traversed by the sonication pathway) will be excluded from this study
  • Subjects who have an Overall Skull Density Ratio of 0.30 (±0.05) or less as calculated from the screening CT.
  • It should be noted that for those candidates whose SDR ratio score is within the standard deviation, full technical assessment should be performed and reviewed by study investigator with the support of the sponsor.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

China1 site

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

Other trials in China

Japan1 site

  • Shonan Fujisawa Tokushukai Hospital

    Fujisawa, Kanagawa

Other trials in Japan

About this study

Official title: A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease

Safety and Effectiveness in ExAblate Neuro treatment of medication-refractory tremor in subjects with idiopathic Parkinson's disease.

Read the detailed description

The goal of this prospective, single-arm, multi-site, feasibility study is to develop data to evaluate the safety and effectiveness of unilateral focused ultrasound thalamotomy using this ExAblate Transcranial System in the treatment of medication-refractory tremor resulting from idiopathic Parkinson's disease.

The Indications for Use claim for this system is: treatment of medication-refractory tremor in subjects with idiopathic Parkinson's disease.

Being tested
ExAblate Neuro Thalamotomy 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 Neuro Thalamotomy TreatmentDevice

    Also called MRgFUS Vim ablation, Non-invasive Focused Ultrasound Ablation of Thalamus Vim nucleus

    Non-invasive Focused Ultrasound Ablation of Thalamus Vim nucleus using ExAblate MRgFUS system for treatment Tremor Dominant Parkinson Disease

Study groups in NCT04002596
Study groupRoleWhat they receive
ExAblate MRgFUS treatmentExperimentalAblation of Thalamus Vim nucleus with ExAblate 4000 Neuro MRgFUS for TDPD
Receives: Device: ExAblate Neuro Thalamotomy Treatment

What is being measured

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

  1. Clinical Rating Scale for Tremor

    Primary effectiveness will be a comparison of the CRST scores at baseline vs. 3 months. (Range 0-152, scores are combined, the higher the score, the greater the clinical level of tremor, the worse clinical outcome is)

    Measured: 3 Months after Treatment

  2. Severity of Device and Procedure related complications

    To evaluate the incidence and severity of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor dominant PD after the ExAblate treatment and during the follow-up period of up up to 1 year

    Measured: 1 year

Secondary outcomes (3)

  1. Clinical Rating Scale for Tremor, Total Score

    On-medication, total tremor (CRST) score (Range 0-152, scores are combined, the higher the score, the greater the clinical level of tremor, the worse clinical outcome is)

    Measured: 1 year

  2. Clinical Rating Scale for Tremor, Part C

    Level of disability measured from Part C subsection of CRST - Subcore of sections 16 to 23 (Range 0-32, scores are combined, the higher the scub-score, the greater the level of subject's disability, the worse clinical outcome is)

    Measured: 1 year

  3. Parkinson's Disease Questionnaire - 39

    Quality of life assessment with PDQ-39 (Range 0-156, scores are combined, the higher the score, the greater the level of clinical expression of Parkinson Disease, the worse clinical outcome is)

    Measured: 1 year

Timeline

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

  1. First posted28 Jun 2019
  2. Study start6 Feb 2017
  3. Primary completion29 Sep 2019
  4. Study completion15 Jan 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
ExAblate Neuro Treatment Group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04002596
Sponsor's protocol ID
PD001J
Acronym
TDPD
Status last verified
Jun 2026
First submitted
7 Jan 2019
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ExAblate Neuro Thalamotomy Treatment in people with Parkinson Disease, run by InSightec at 2 sites in 2 countries.

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 11 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 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China, Japan. 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?

Clinical Rating Scale for Tremor (time frame: 3 Months after Treatment). 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 NCT04002596.

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 24 Jun 2026.

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