Location- and Frequency-Dependent Effects of Thalamic Temporal Interference Stimulation During Sleep

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07498270
Status
Recruiting
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Conditions

  • Healthy Adult Participants
  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Magnetic Resonance Imaging (MRI) — OTHER
    MRI is to optimize placement of multipolar TI-TES
  • Broad thalamic stimulation (TI-TES) — DEVICE
    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 stimulation — DEVICE
    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
  • Anterior thalamic stimulation (TI-TES) — DEVICE
    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
  • Posterior thalamic stimulation (TI-TES) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jun 5, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: All Participants
    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.

Primary Outcome Measure

Change in Spectral Power (SFA) for Active TI-TES vs SHAM [ Time Frame: during each of the 3 overnight visits, 5 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wisconsin Institute for Sleep and ConsciousnessMadisonWisconsin53719-

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By research site
Wisconsin Institute for Sleep and Consciousness· Madison, WI

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