Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Ultrasound opens brain barrier to deliver Parkinson's drug in first human test

NCT ID NCT05565443

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase trial tests whether a focused ultrasound device can safely open the blood-brain barrier to deliver a missing enzyme (GCase) directly into the brains of 14 people with Parkinson's disease. The goal is to see if this delivery method is safe and feasible, not yet to prove it works as a treatment. Participants must have a specific genetic mutation linked to Parkinson's.

What this could mean

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

Active substance
recombinant glucocerebrosidase (GCase) enzyme
What this could lead to
If successful, this could lead to a new way to deliver treatments directly to the brain for Parkinson's disease, potentially slowing disease progression.
What could go wrong
This is an early, small trial (14 people) focused on safety and feasibility, not yet on effectiveness. The procedure involves opening the blood-brain barrier, which carries risks like bleeding or swelling.

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

About 14 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Dec 2028

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

35 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 or women between age 35 and 80 years, inclusive. * Able and willing to give informed consent. * Diagnosis of PD satisfying MDS Clinical Diagnostic Criteria for PD * At least 2 years from initial diagnosis * Hoehn and Yahr Stage 1-3 on PD medication * Dopaminergic deficit by a positive DAT SPECT scan * On stable regimen of PD medications for at least 90 days prior to the study * American Society of Anesthesiologists (ASA) score 1-3 * Harbor at least one GBA mutation if enrolled in the GBA PD arm or two wild-type GBA alleles if enrolled in the idiopathic PD arm Exclusion Criteria: * Positive pregnancy test (for pre-menopausal women). * Contraindication to DEFINITY ultrasound contrast agent or perflutren (e.g. hypersensitivity, known left or bidirectional cardiac shunt) * Contraindication to MRI or gadolinium-DTPA (e.g. incompatible device, hypersensitivity) * Insulin-dependent diabetes mellitus that is not well-controlled or that in the Investigator's opinion precludes participation in the study. * Severely impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2 and/or on dialysis. * Currently participating in another clinical therapeutic trial * Patient receiving bevacizumab (Avastin) therapy * Subjects with evidence of cranial or systemic infection. * Cerebral or systemic vasculopathy. * Documented cerebral infarction within the past 12 months or TIA in the past 1 month. * Contraindication to GCase enzyme therapy, specifically previous hypersensitivity reaction to GCase enzyme therapy * Parkinsonism plus symptoms, secondary parkinsonism * Previous neurosurgical procedure for PD

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Parkinsons disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Parkinsons disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sunybrook Research Institute

    RECRUITING

    Toronto, Ontario, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.