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| ID | Type | Description | Link |
|---|---|---|---|
| SMPH/PSYCHIATRY/PSYCHIATRY | Other Identifier | UW Madison | |
| Protocol Version 3/24/2026 | Other Identifier | UW Madison |
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The goal of this clinical trial is to find out whether a type of electrical brain stimulation, called temporal interference stimulation, can temporarily change the way different parts of the brain communicate with each other.
Participants will:
This study will evaluate the effectiveness of personalized thalamic temporal interference transcranial electrical stimulation (TI-TES) to modulate thalamocortical activity and connectivity in healthy adults. Using a within-subject, counterbalanced crossover design, participants will complete two stimulation phases: (1) repeated overnight TI-TES or sham stimulation during NREM sleep and (2) repeated during quiet wakefulness. Each phase consists of two sessions. Phases are separated by a ≥4-week washout. Resting-state functional magnetic resonance imaging (fMRI) will be acquired before and after each phase to assess sustained changes in thalamocortical functional connectivity, with high-density EEG providing secondary measures of brain-state-specific oscillatory modulation (sigma/spindles in sleep, alpha in wake).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation | Experimental | Participants will complete two stimulation phases-overnight TI-TES during non-rapid eye movement (NREM) sleep and TI-TES during quiet wakefulness |
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| Sham stimulation | Sham Comparator | ~10 participants will be assigned to sham stimulation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporal Interference Transcranial electrical stimulation (TI-TES) | Device | TI-TES uses specific electrode arrangement patterns to selectively stimulate the brain. Participants will wear an hdEEG (high density electroencephalography) cap which will allow intermittent periods of stimulation from TI-TES. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in thalamocortical functional connectivity (FC): resting state fMRI | Resting-state fMRI will be used to assess changes in thalamocortical functional connectivity before and after repeated thalamic TI-TES delivered during NREM sleep and quiet wakefulness. | Pre- to post-intervention, up to 2 weeks |
| Difference in magnitude of FC changes between sleep and wake | The magnitude of FC changes between sleep and wake stimulation phases will be evaluated. | 8 weeks |
| Difference in spatial distribution of FC changes between sleep and wake | The spatial distribution of FC changes between sleep and wake stimulation phases will be evaluated. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sigma-band power (EEG, sleep phase) | Sigma band power will be measured with high density EEG (hdEEG) during stimulation, and will be analyzed to quantify stimulation-related changes in sigma-band power during NREM sleep. | During and after each overnight stimulation session, up to 1 week |
| Change in alpha band power during wake stimulation sessions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sean Prahl | Contact | 262-395-8675 | titan@psychiatry.wisc.edu | |
| Larissa Albantakis, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Larissa Albantakis, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin - Madison | Recruiting | Madison | Wisconsin | 53705 | United States |
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This pilot study employs a within-subject, counterbalanced crossover design in which each participant serves as their own control.
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| Sham stimulation | Device | Sham (ramp only) stimulation will briefly ramp up and down at the beginning and end of each stimulation train, without delivering continuous stimulation throughout. |
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Alpha band power will be measured with hdEEG during stimulation, and will be analyzed to quantify stimulation-related changes in alpha-band power during quiet wakefulness stimulation. |
| During and after each wake stimulation session, up to 1 week |
| Return to baseline thalamocortical FC | After the ≥4-week washout, thalamocortical FC will be assessed by resting-state fMRI prior to the second stimulation phase. | 8 weeks |
| Change in structural thalamocortical connectivity | Will be measured using diffusion-weighted imaging (DWI) in each phase. | Pre- to post-intervention, up to 2 weeks |
| Change in mood | Mood will be scored using Positive and Negative Affect Schedule (PANAS). PANAS is a 20 item questionnaire, each item is rated on a 5-point scale, with 1 = "Very slightly or not at all" and 5 = "Extremely". To score PANAS, sum the scores for the 10 Positive Affect (PA) items and the 10 Negative Affect (NA) items separately on the 5-point scale. Higher scores for PA indicate a greater degree of positive emotion, while higher scores for NA indicate more negative emotion, with both scales ranging from 10 (low affect) to 50 (high affect). | Baseline to 12 weeks |
| Change in Boston Cognitive Assessment (BoCA) | BoCA™ evaluates eight cognitive domains using randomized, non-repeating tasks to minimize practice effects. The total maximum score is 30. Higher scores indicate better cognitive performance. | Baseline to 12 weeks |
| Change in spindle characteristics: Density | HdEEG will be analyzed to assess stimulation-related changes in spindle density during NREM sleep. | Up to 1 week |
| Change in spindle characteristics: Amplitude | HdEEG will be analyzed to assess stimulation-related changes in spindle amplitude during NREM sleep. | Up to 1 week |
| Change in spindle characteristics: Duration | HdEEG will be analyzed to assess stimulation-related changes in spindle duration during NREM sleep. | Up to 1 week |