Sound waves aimed at a tiny brain spot to quiet Parkinson's dyskinesia

NCT ID NCT02347254

What the study statuses mean

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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 Results may not be published yet.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

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This status has not been confirmed recently, so it may be out of date.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 Oct 20, 2026 · Last updated Oct 21, 2026 · Updated 1 time

Summary

Researchers are testing whether MRI-guided focused ultrasound can safely and effectively reduce L-dopa induced dyskinesia, the involuntary movements that can develop in people with Parkinson's disease after long-term use of levodopa. The procedure uses sound waves to create a small lesion in one part of the brain (a unilateral pallidotomy) without open surgery. The trial enrolls a small number of adults with Parkinson's disease and dyskinesia, and tracks safety and dyskinesia severity using standard rating scales over 12 months.

What this could mean

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

Active substance
MRI-guided focused ultrasound brain procedure (ExAblate)
What this could lead to
If it works, this could offer a non-surgical, non-drug option to ease the involuntary movements that can come with long-term Parkinson's medication.
What could go wrong
This is a very small feasibility trial, so any safety or benefit signal is early and uncertain. Focused ultrasound brain treatment carries risks such as bleeding, swelling, or unintended damage to nearby brain tissue.

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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

2 people

The number who actually took part.

Started

Sep 2014

Finished

Dec 2017

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

18 to 80 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: * Men and women, between 18 and 80 years, inclusive. * Patients who are able and willing to give consent and able to attend all study visits. * Able to communicate sensations during the ExAblate MRgFUS treatment * Stable doses of all medications for 30 days prior to study entry and for the duration of the study. * Inclusion and exclusion criteria have been agreed upon by two members of the medical team. Exclusion Criteria: * Patients with unstable cardiac status including: * Unstable angina pectoris on medication * Patients with documented myocardial infarction within six months of protocol entry * Congestive heart failure requiring medication (other than diuretic) * Patients on anti-arrhythmic drugs * Severe hypertension (diastolic BP \> 100 on medication) * Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc. * Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease * Severely impaired renal function (estimated glomerular filtration rate \< 30ml/min/1.73 m2) or receiving dialysis * History of abnormal bleeding and/or coagulopathy * Cerebrovascular disease (multiple CVA or CVA within 6 months) * Symptoms and signs of increased intracranial pressure (e.g. headache, nausea, vomiting, lethargy, and papilledema) * Active or suspected acute or chronic uncontrolled infection * History of intracranial hemorrhage * 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 * Individuals 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 * Patients unable to communicate with the investigator and staff. * Presence of any other neurodegenerative disease like parkinson-plus syndromes suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease. * Presence of significant cognitive impairment as determined with a score \<= 24 on the Mini Mental Status Examination (MMSE) * Patients with a history of seizures within the past year * Patients with psychiatric illness that are not well controlled. Any presence of psychosis will be excluded. Patients with mood disorders including depression will be excluded if they have exhibited symptoms within 6 months while on medication. Patients who have been treated with transcranial magnetic stimulation or ECT will be excluded. * Patients with risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter) or a documented coagulopathy * Patients with brain tumors * Any illness that in the investigator's opinion preclude participation in this study. * Pregnancy or lactation. * Patient is unable to provide their own consent for any reason. * Legal incapacity or limited legal capacity. * Patients who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia * History of immunocompromise, including patient who is HIV positive * Known life-threatening systemic disease

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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

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

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