Focused Ultrasound Modulation of the Globus Pallidus Interna in Schizophrenia

Conditions

• Schizophrenia
• Schizophrenia Schizoaffective

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

This is a single-site, phase 2, sham-controlled random-order cross-over pilot trial of PLIFUS targeting the right GPi in individuals with schizophrenia. Twelve individuals with schizophrenia who report continuous hallucinations or delusions of mild or greater severity will receive one session of PLIFUS and one session of sham PLIFUS in random order, one week apart. If no effect of PLIFUS is detected on measures of functional connectivity or psychotic symptoms in the first four completers, the trial will be changed to 3 sessions of PLIFUS or sham administered over 5 days.

Key Dates

Start date

Apr 6, 2023

Status verified

May 2025

Primary completion

Mar 25, 2024

Completion

Apr 1, 2024

Study Design

Enrollment

15 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Pulsed Low-Intensity Focused Ultrasound (PLIFUS), then Sham
  Participants will receive PLIFUS sonication on the first intervention visit, then sham sonication on the second intervention visit. Visits will be separated by 1 week. Sonication at both visits will be preceded and followed by fMRI and an exit medical examination. Sonication will be delivered in a pulse pattern over 10 minutes.
• Experimental: Sham, then Pulsed Low-Intensity Focused Ultrasound (PLIFUS)
  Participants will receive sham sonication on the first intervention visit, then PLIFUS sonication on the second intervention visit. Visits will be separated by 1 week. Sonication at both visits will be preceded and followed by fMRI and an exit medical examination. Sonication will be delivered in a pulse pattern over 10 minutes.

Primary Outcome Measure

Change in Globus Pallidus Interna (GPi) Functional Connectivity During PLIFUS Intervention Visit [ Time Frame: Immediately pre-sonication and 10 minutes post-sonication at Intervention Visit 1 (Day 0) and Intervention Visit 2 (Day 7) ]

Locations (2)

Find similar trials in Brooklyn, NY

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