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Sound waves could tame Parkinson's tremors and twitches

NCT ID NCT03319485

Disease control Sponsor: InSightec Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a non-invasive treatment using focused ultrasound to target a small area in the brain that controls movement. It is for people with advanced Parkinson's disease whose medication no longer controls their involuntary movements or motor fluctuations. The goal is to see if this one-time procedure can safely reduce these symptoms and improve daily function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

92 people

The number who actually took part.

Started

Feb 2018

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Men and women, age 30 years and older. 2. Subjects who are able and willing to give informed consent and able to attend all study visits through 12 Months. 3. Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site. 4. Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor subscale in the ON vs OFF medication state. 5. MDS-UPDRS score of ≥ 20 in the meds OFF condition OR Motor complications of PD on optimum medical treatment . 6. Subjects should be on a stable dose of all PD medications for 30 days prior to study entry as determined by medical records. 7. Subject is able to communicate sensations during the ExAblate procedure. 8. Subjects on stable antidepressant medications for at least 3 months Exclusion Criteria: 1. Hoehn and Yahr stage in the ON medication state of 3 or greater. 2. 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. 3. Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications. 4. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia. 5. Presence of significant cognitive impairment using MMSE ≤ 24. 6. Unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation. 7. Subjects with an active alcohol or drug dependency or history of drug/alcohol abuse within the past year 8. Subjects with unstable cardiac status 9. Severe hypertension (diastolic BP \> 100 on medication). 10. Current medical condition resulting in abnormal bleeding and/or coagulopathy. 11. 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. 12. 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 13. Patient with kidney disease or on dialysis. 14. Subjects with standard contraindications for MR imaging 15. Significant claustrophobia that cannot be managed with mild medication. 16. Subjects who weigh more than the upper weight limit of the MR scanner table and who cannot fit into the MR scanner. 17. Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment. 18. History of intracranial hemorrhage, multiple strokes, or a stroke within past 6 months. 19. Subjects with a history of seizures within the past year. 20. Subjects with brain tumors. 21. Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment. 22. Are participating or have participated in another clinical trial in the last 30 days.

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria di Verona, Univerista di Verona

    Verona, 37134, Italy

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CINAC-Hospital HM Puerta del Sur

    Móstoles, Madrid, 28938, Spain

  • Chang Bing Show Chwan Memorial Hospital

    Changhua, Taiwan

  • Clinica Universidad De Navarra

    Pamplona, Navarre, 31008, Spain

  • Fondazione IRCCS Neurological Institute Carlo Besta

    Milan, 20133, Italy

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • New York University Health Langone

    New York, New York, 10016, United States

  • Palm Beach Neuroscience Institute/Sperling Medical Group

    Boynton Beach, Florida, 33472, United States

  • Pennsylvania Hospital Department of Neurosurgery

    Philadelphia, Pennsylvania, 19106, United States

  • Rambam Health Care

    Haifa, 3109601, Israel

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • St. Mary's Hospital

    London, United Kingdom

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • The Ohio State Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8, Canada

  • University of Maryland Medical System

    Baltimore, Maryland, 21201, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

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