Overnight Thalamic TES-TI to Modulate Sleep Spindles in Individuals With Schizophrenia Spectrum Disorders and Matched Healthy Controls
Part of paid clinical trials in Madison, Wisconsin.
- Sponsor
- University of Wisconsin, Madison
- Study ID
- NCT07680114
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 50 Years
- Healthy Volunteers
- Accepted
Interventions
- TES-TI — DEVICEDuring the stimulation night, TES-TI will be delivered during stable N2 sleep in 3-minute epochs separated by 6-minute intervals, with up to 20 protocols per night, using randomized 10 Hz, 14 Hz, and carrier-only control conditions under continuous sleep-technician monitoring.
- Sham TES-TI — DEVICEramp-sham stimulation only
Study Details
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.
Key Dates
- Start date
- Aug 31, 2026
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Participants with SSD
- Experimental: Healthy Controls
Primary Outcome Measure
Change in spindle-frequency activity (8-16 Hz spectral power) [ Time Frame: data collected over two overnight visits separated by at least 2 weeks during stable N2 sleep ]
Central Contacts
- ONSETS Study608-620-4458
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53719 | - |
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