An interventional study of Magnetic Resonance Imaging (MRI) and Broad thalamic stimulation (TI-TES) in Healthy Adult Participants and Healthy Participants, sponsored by University of Wisconsin, Madison. Recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Basic science
This study is to find out whether a type of non-invasive electrical brain stimulation called temporal interference transcranial electrical stimulation (TI-TES) can temporarily change brain activity during sleep, especially sleep spindles (brain rhythms in the \~8-16 Hz range). Up to 24 healthy participants in Dane County, Wisconsin will be enrolled for 3 overnight study visits. Participants can expect to be on study for approximately 5 weeks, depending on scheduling availability.
This single-site, single-blind, experimental study will test whether thalamic temporal interference transcranial electrical stimulation (TI-TES) delivered during Non-Rapid Eye Movement (NREM) sleep can enhance spindle-frequency activity (SFA) in healthy adults and identify optimal stimulation parameters across frequency and thalamic target location.
After screening/consent, participants will complete a structural MRI for personalized montage optimization, then undergo three overnight High-Density Electroencephalography (hdEEG) and Polysomnography (PSG) sleep sessions (10-12 hours each) in a randomized, counterbalanced crossover design, one session per stimulation location (broad thalamic, anterior thalamic, posterior thalamic). During stable N2 sleep, TI-TES will be delivered in 3-minute epochs separated by 6-minute intervals, for up to 24 epochs per night, under real-time sleep-technician monitoring. The study uses a two-phase frequency plan: Phase 1 (\~10 participants) will test 10 Hz, 14 Hz, and matched carrier-only SHAM; contingent on feasibility/sensitivity, Phase 2 (\~10 participants) will expand frequencies across 8-16 Hz. Primary outcomes quantify stimulation-related increases in 8-16 Hz spectral power (SFA) and spindle characteristics comparing active TI-TES versus SHAM and across stimulation locations/frequencies.
Primary Objectives:
Characterize stimulation-related changes in spindle characteristics (density, amplitude, duration, topography) for slow and fast spindle subtypes.
Secondary Objectives:
University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will complete three overnight stimulation sessions with simultaneous 256-channel hdEEG and PSG, in a randomized, counterbalanced crossover design, with each overnight session using a distinct personalized montage targeting one of three thalamic locations (broad thalamic, anterior thalamic, posterior thalamic), and sessions spaced at least three days apart.
Other: Magnetic Resonance Imaging (MRI) · Device: Broad thalamic stimulation (TI-TES) · Device: Carrier only SHAM stimulation · Device: Anterior thalamic stimulation (TI-TES) · Device: Posterior thalamic stimulation (TI-TES)
MRI is to optimize placement of uni- or multipolar TI-TES
Also known as: structural MRI
Stimulation targeted at the whole thalamus. Within each overnight session, up to 24 stimulation protocols will be administered, randomized across frequencies (including SHAM). Stimulation will be initiated by trained sleep technicians during stable N2 sleep and delivered in 3-minute epochs separated by 6-minute intervals to enable comparison of PRE, STIM, and POST intervals
Carrier only SHAM condition. Within each overnight session, up to 24 stimulation protocols will be administered, randomized across frequencies (including SHAM). Stimulation will be initiated by trained sleep technicians during stable N2 sleep and delivered in 3-minute epochs separated by 6-minute intervals to enable comparison of PRE, STIM, and POST intervals
Stimulation targeted at the anterior thalamus. Within each overnight session, up to 24 stimulation protocols will be administered, randomized across frequencies (including SHAM). Stimulation will be initiated by trained sleep technicians during stable N2 sleep and delivered in 3-minute epochs separated by 6-minute intervals to enable comparison of PRE, STIM, and POST intervals
Stimulation targeted at the posterior thalamus. Within each overnight session, up to 24 stimulation protocols will be administered, randomized across frequencies (including SHAM). Stimulation will be initiated by trained sleep technicians during stable N2 sleep and delivered in 3-minute epochs separated by 6-minute intervals to enable comparison of PRE, STIM, and POST intervals.
Change in Spectral Power (SFA) for Active TI-TES vs SHAM
Comparing active TI-TES vs carrier only SHAM, evaluated using both STIM-PRE and POST-PRE contrasts.
Time frame: during each of the 3 overnight visits, 5 weeks
Change in SFA by Location
Changes in 8-16 Hz spectral power across frequency-location combinations (broad thalamic, anterior thalamic, posterior thalamic) for STIM-PRE and POST-PRE to identify the most effective parameters within the tested parameter space.
Time frame: during each of the 3 overnight visits, 5 weeks
Spindle Density in slow (8-12 Hz) and fast (13-16 Hz) SFA
Changes in slow (8-12 Hz) and fast (13-16 Hz) spindle characteristics (density) using STIM-PRE and POST-PRE contrasts
Time frame: during each of the 3 overnight visits, 5 weeks
Spindle Amplitude in slow (8-12 Hz) and fast (13-16 Hz) SFA
Changes in slow (8-12 Hz) and fast (13-16 Hz) spindle characteristics (amplitude) using STIM-PRE and POST-PRE contrasts
Time frame: during each of the 3 overnight visits, 5 weeks
Spindle Duration in slow (8-12 Hz) and fast (13-16 Hz) SFA
Changes in slow (8-12 Hz) and fast (13-16 Hz) spindle characteristics (duration) using STIM-PRE and POST-PRE contrasts
Time frame: during each of the 3 overnight visits, 5 weeks
Spindle Topography in slow (8-12 Hz) and fast (13-16 Hz) SFA
Changes in slow (8-12 Hz) and fast (13-16 Hz) spindle characteristics (topography) using STIM-PRE and POST-PRE contrasts
Time frame: during each of the 3 overnight visits, 5 weeks
Change in Spectral Power (SFA) for SHAM during slow vs fast conditions
Changes in slow (8-12 Hz) and fast (13-16 Hz) spectral power relative to SHAM
Time frame: during each of the 3 overnight visits, 5 weeks
Changes in slow-wave spectral power (0.5-4.0 Hz) relative to SHAM
Changes in slow-wave spectral power (0.5-4.0 Hz) relative to SHAM
Time frame: during each of the 3 overnight visits, 5 weeks
Changes in Slow-wave Density
Changes in slow-wave characteristics (density) in STIM-PRE and POST-PRE contrasts.
Time frame: during each of the 3 overnight visits, 5 weeks
Changes in Slow-wave Amplitude
Changes in slow-wave characteristics (amplitude) in STIM-PRE and POST-PRE contrasts.
Time frame: during each of the 3 overnight visits, 5 weeks
Changes in Slow-wave Duration
Changes in slow-wave characteristics (duration) in STIM-PRE and POST-PRE contrasts.
Time frame: during each of the 3 overnight visits, 5 weeks
Changes in Spindle and Slow Oscillation Coupling
Changes in SO-Spindle coupling, quantified via phase-amplitude coupling metrics
Time frame: during each of the 3 overnight visits, 5 weeks
Changes in directed hdEEG functional connectivity
Changes in directed hdEEG functional connectivity measured using the phase slope index (PSI), with effects assessed over stimulation-related intervals (STIM-PRE and POST-PRE).
Time frame: during each of the 3 overnight visits, 5 weeks
Plan to share: No
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University of Wisconsin, Madison