Ultrasound zaps brain barrier in Parkinson's dementia – first safety results in

NCT ID NCT03608553

Completed Knowledge-focused Sponsor: InSightec Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a focused ultrasound device can safely and temporarily open the blood-brain barrier in 20 people with mild-to-moderate Parkinson's disease dementia. The goal was to see if the procedure is safe and feasible, not to treat the disease itself. Researchers monitored side effects using exams and brain scans.

What this could mean

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

Active substance: MR-guided focused ultrasound (Exablate device)
What this could lead to: If successful, this approach could enable future treatments to reach the brain more effectively for Parkinson's dementia.
What could go wrong: This was a very small, early feasibility study with only 20 participants. It focused on safety, not on treating symptoms or slowing the disease. The procedure may carry risks like bleeding or swelling in the brain.

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Conditions

The condition(s) this trial relates to.

Lewy body dementia

As listed by the trial registrant

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

PARKINSONS DISEASE WITH DEMENTIA

Contacts and locations

Locations

HM Hospitales Puerta del Sur - CINAC

Móstoles, Madrid, 28938, Spain

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