Clinical Trial

Overnight Thalamic TES-TI to Modulate Sleep Spindles in Individuals With Schizophrenia Spectrum Disorders and Matched Healthy Controls

Study acronym: ONSETS
Recruiting
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Summary
This study to find out whether a type of non-invasive electrical brain stimulation called transcranial electrical stimulation with temporal interference (TES-TI) can temporarily change brain activity during sleep-especially sleep spindles (brain rhythms in the \~8-16 Hz range). The investigators are focusing on the thalamus, a deep brain region that helps coordinate brain activity during non-REM sleep. Sleep spindles are often reduced in schizophrenia, so this study is to see whether TES-TI can change spindle activity in individuals with schizophrenia spectrum disorders (SSD) and in healthy adults. To study this, a structural MRI scan will be used to customize where the stimulation electrodes are placed, and then TES-TI will be applied during one of two overnight sleep lab visits while brain activity is recorded with high-density EEG and standard sleep sensors. The other overnight is a baseline/control night during which only sham stimulation is delivered. The goal is to determine whether TES-TI during sleep can increase spindle-frequency activity in this population.
Protocol Amendment History 1 change
critical Recruitment opened 2026-08-11
Trial Details
NCT Number NCT07680114
Lead Sponsor University of Wisconsin, Madison
Collaborators: Alkermes, Inc.
Conditions Schizophrenia
Enrollment 20 participants
Start Date 2026-08
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-10