Sound waves zapped brain to stop Parkinson's shakes

NCT ID NCT04002596

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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 Results may not be published yet.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

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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This status has not been confirmed recently, so it may be out of date.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 tested a device that uses focused ultrasound to create a small burn in a brain area linked to tremors. It included 26 people with Parkinson's disease whose tremors did not improve with medication. The goal was to see if the procedure is safe and reduces shaking.

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 Neuro device)
What this could lead to
If it works, this could offer a non-invasive option to reduce severe tremors in Parkinson's patients who don't respond well to medication.
What could go wrong
This was a small, early feasibility study with only 26 participants. The procedure may not work for everyone and carries risks like side effects from brain tissue ablation.

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

26 people

The number who actually took part.

Started

Feb 2017

Finished

Jan 2021

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 3 Months 3. Subjects with a diagnosis of idiopathic PD as confirmed from clinical history and examination by a movement disorder neurologist at the site 4. 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. 5. 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. 6. 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: \[speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities\]) 7. 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 8. Subjects should be on a stable dose of all PD medications for 30 days prior to study entry. 9. 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. 10. Subject is able to communicate sensations during the ExAblate Transcranial procedure. Exclusion Criteria: 1. Subjects with unstable cardiac status including: 1. Unstable angina pectoris on medication 2. Subjects with documented myocardial infarction within six months of protocol entry 3. Significant congestive heart failure defined with ejection fraction \< 40 4. Subjects with unstable ventricular arrhythmias 5. Subjects with atrial arrhythmias that are not rate-controlled 2. 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: 1. 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). 2. 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) 3. Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct) 4. 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). 3. Severe hypertension (diastolic BP \> 100 on medication) 4. Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc. 5. Significant claustrophobia that cannot be managed with mild medication. 6. Current medical condition resulting in abnormal bleeding and/or coagulopathy 7. 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; 8. 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 9. 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 10. History of intracranial hemorrhage 11. History of multiple strokes, or a stroke within past 6 months 12. Subject who weigh more than the upper weight limit of the table or subjects who will not fit into the MR scanner 13. Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment. 14. Are participating or have participated in another clinical trial in the last 30 days 15. Subjects unable to communicate with the investigator and staff. 16. 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. 17. Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications. 18. Presence of significant cognitive impairment as determined with a score ≤ 24 on the Mini Mental Status Examination (MMSE) 19. 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 20. 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. 21. Legal incapacity or limited legal capacity as determined by the neuropsychologist 22. Subjects with a history of seizures within the past year 23. Subjects with brain tumors 24. Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment. 25. Any illness that in the investigator's opinion preclude participation in this study. 26. Pregnancy or lactation. 27. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia 28. 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 29. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003, China

  • Shonan Fujisawa Tokushukai Hospital

    Fujisawa, Kanagawa, Japan

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