Focused Ultrasound Modulation of the Globus Pallidus Interna in Schizophrenia

PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

April 6, 2023

Primary Completion Date

March 25, 2024

Study Completion Date

April 1, 2024

Conditions
SchizophreniaSchizophrenia Schizoaffective
Interventions
DEVICE

PLIFUS

The Sonicator-1000 system will non-invasively deliver ultrasound sonications transcranially that selectively target specific areas of the brain using a neuronavigation system and the participant's MRI brain scan. The sonication parameters follow FDA and Electrotechnical Technical Commission regulation standards for diagnostic and therapeutic ultrasound.

DEVICE

Sham PLIFUS

Sham PLIFUS treatment delivers noise and patient experience that is identical to PLIFUS with Sonicator-1000 system.

DEVICE

MRI

A total of 5 MRIs will be performed using a Siemens 3T Prisma; one prior to the intervention visit, and one preceding and one immediately after each of the two sonication/sham visits.

Trial Locations (2)

10016

NYU Langone Health, New York

11220

NYU Langone Brooklyn, Brooklyn

All Listed Sponsors
collaborator

The New York Community Trust

OTHER

collaborator

Doris Duke Charitable Foundation

OTHER

lead

NYU Langone Health

OTHER