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NCT05643196 · ClinicalTrials.gov registry record · Phase 2
Focused Ultrasound Modulation of the Globus Pallidus Interna in Schizophrenia
A Phase 2 study of Schizophrenia and Schizophrenia Schizoaffective, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 2
- Study locations
NCT05643196 is a Phase 2 study of Schizophrenia and Schizophrenia Schizoaffective that has completed, run by NYU Langone Health. The registered enrollment target is 15 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT05643196, a Phase 2 study of Schizophrenia and Schizophrenia Schizoaffective, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DEVICE MRI
- DEVICE PLIFUS
- DEVICE Sham PLIFUS
Study Locations (2)
New York
- NYU Langone Brooklyn - Brooklyn
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-04-06 |
| Est. Completion | 2024-04-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05643196
The ClinicalTrials.gov registry entry for NCT05643196 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (93% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 3 interventions - of which MRI is the first listed.
NCT05643196 reports 2 study locations spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05643196 about?
NCT05643196 is a clinical study titled "Focused Ultrasound Modulation of the Globus Pallidus Interna in Schizophrenia". 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 PLI...
What is the current status of trial NCT05643196?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2023-04-06. Estimated completion is 2024-04-01.
What conditions does trial NCT05643196 study?
This clinical trial studies the following conditions: Schizophrenia, Schizophrenia Schizoaffective.
What interventions are being tested in trial NCT05643196?
The interventions under investigation include: MRI (DEVICE), PLIFUS (DEVICE), Sham PLIFUS (DEVICE).
Who is sponsoring clinical trial NCT05643196?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05643196 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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