Trial results for a pilot study evaluating Focused Ultrasound Modulation of the Globus Pallidus Interna (PLIFUS) in Schizophrenia were posted on 2025-05-30, with participants in the PLIFUS group showing a mean reduction of -1.4 on the Auditory Hallucinations Rating Scale (AHRS).
Background
Schizophrenia is a complex mental disorder characterized by a range of symptoms, including hallucinations and delusions, which can significantly impact an individual's daily life. For some individuals, these symptoms can be continuous and persistent, even with existing treatments. The trial specifically targeted individuals with schizophrenia who reported continuous hallucinations or delusions of mild or greater severity, suggesting an exploration into novel approaches for managing these challenging symptoms. Focused ultrasound modulation represents an investigational method to potentially modulate brain activity in specific regions, such as the globus pallidus interna (GPi), which may be implicated in the pathophysiology of schizophrenia symptoms.
Trial design
This completed Phase 2, single-site, sham-controlled random-order cross-over pilot trial enrolled 15 individuals with Schizophrenia or Schizophrenia Schizoaffective. The study evaluated Focused Ultrasound Modulation of the Globus Pallidus Interna (PLIFUS) targeting the right GPi. Participants received one session of PLIFUS and one session of sham PLIFUS in random order, one week apart. The trial's design included a contingency to modify the intervention to three sessions of PLIFUS or sham over five days if no effect was detected in the first four completers.
Key results
The trial results provided measurements for changes from baseline in auditory hallucinations and delusions:
- Change in Auditory Hallucinations Rating Scale (AHRS) Score From Baseline:
- In the PLIFUS group, the mean change was -1.4 (Standard Deviation 2.4) score on a scale.
- In the Sham group, the mean change was -1 (Standard Deviation 1.9) score on a scale.
- Change in Delusions Experience Sampling Assessment (DESA) Score From Baseline:
- In the PLIFUS group, the mean change was -1 (Standard Deviation 3.4) score on a scale.
- In the Sham group, the mean change was 0.3 (Standard Deviation 2.9) score on a scale.
What this means
The posted results from this pilot trial suggest a potential signal for Focused Ultrasound Modulation of the Globus Pallidus Interna (PLIFUS) in reducing symptoms of schizophrenia. In the PLIFUS group, participants experienced a mean reduction of -1.4 on the Auditory Hallucinations Rating Scale (AHRS) and a mean reduction of -1.0 on the Delusions Experience Sampling Assessment (DESA) from baseline. Comparatively, the sham group showed a mean reduction of -1.0 on the AHRS and a mean increase of 0.3 on the DESA. These findings indicate that PLIFUS may offer a greater symptomatic improvement in both auditory hallucinations and delusions compared to sham. However, given the small enrollment of 15 participants and the pilot nature of this Phase 2 study, these results require confirmation through larger, more definitive clinical trials to establish efficacy and safety.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05643196, titled "Focused Ultrasound Modulation of the Globus Pallidus Interna in Schizophrenia", were posted on 2025-05-30 on clinicaltrials.gov.