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Sound waves aimed at brain may ease Parkinson's tremors

NCT ID NCT03964272

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small study tested whether a device that uses focused ultrasound (sound waves) can safely improve movement problems in people with Parkinson's disease. Six participants who already had one side treated received the second side. The goal was to check safety and see if symptoms like tremor and stiffness get better. Results are preliminary and more research is needed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
focused ultrasound (Exablate device)
What this could lead to
If successful, this could offer a non-invasive way to improve movement problems in Parkinson's disease without surgery or implants.
What could go wrong
This is a very early, tiny study (6 people) testing safety first. It may not work for everyone, and there are risks like brain swelling or movement side effects.

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

6 people

The number who actually took part.

Started

Jun 2019

Finished

Nov 2023

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 to 75 years

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. Male or Female age 30 years or older 2. Able and willing to give consent and able to attend all study visits 3. A confirmed diagnosis of Parkinsons Disease 4. Subjects that have received unilateral subthalamotomy at least 6 month before the inclusion in bilateral subthalamotomy and present parkinsonian symptoms 5. Able to localize subthalamic nucleus on MRI for treatment 6. Able to communicate sensations during the ExAblate MRgFUS procedure Exclusion Criteria: 1. Hoehn and Yahr stage in the ON medication state of 2.5 or greater 2. Presence of severe dyskinesia as noted by MDS-UPDRS scores 3. Presence of other central neurodegenerative disease 4. Parkinsonian symptoms are a side effect from neuroleptic medications 5. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse 6. History of a bleeding disorder or receiving anticoagulant 7. Subjects with advanced kidney disease or on dialysis 8. Subjects with known intolerance or allergies to the MRI contrast agents. 9. Presence of unknown or MRI unsafe devices anywhere in the body. 10. History of multiple strokes, or a stroke within past 6 months 11. Subjects with a history of seizures within the past year 12. Subjects with malignant brain tumors 13. Women who are pregnant or nursing

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Conditions

The condition(s) this trial relates to.

Neurologic Manifestations Parkinson disease

As listed by the trial registrant

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

Neurologic manifestations Parkinson disease

Contacts and locations

Locations

  • Hospital Universitario HM Puerta Del Sur. CINAC

    Móstoles, Madrid, 28938, Spain

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