About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Medically healthy (based on self-report and study team review)
U.S. citizen or holding permanent resident status
English-speaking (able to provide consent and complete questionnaires)
Disqualifiers
Any current or past history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions (including clinically significant findings identified in first MRI)
History of inpatient psychiatric hospitalization
History of head trauma resulting in prolonged loss of consciousness; or a history of greater than 3 grade I concussions
Current history of poorly controlled headaches including intractable or poorly controlled migraines
Trial design
Single group
Treatments tested in this trial
Magnetic Resonance Imaging (MRI)
Other interventionMRI is to optimize placement of multipolar TI-TES
Broad thalamic stimulation (TI-TES)
DeviceStimulation 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
DeviceCarrier 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)
DeviceStimulation 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)
DeviceStimulation 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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
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
Secondary outcomes
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
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
Changes in Slow-wave Density
Changes in slow-wave characteristics (density) in STIM-PRE and POST-PRE contrasts.
Changes in Slow-wave Amplitude
Changes in slow-wave characteristics (amplitude) in STIM-PRE and POST-PRE contrasts.
Other outcomes
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).
Sponsors and contacts
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University of Wisconsin, Madison
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator