Recruiting

TI-TES

Sponsor:

University of Wisconsin, Madison

Code:

NCT07498270

Conditions

Healthy Adult Participants

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Magnetic Resonance Imaging (MRI)

Broad thalamic stimulation (TI-TES)

Carrier only SHAM stimulation

Anterior thalamic stimulation (TI-TES)

Posterior thalamic stimulation (TI-TES)

Study Details

Brief summary:

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.

Conditions

Healthy Adult Participants

Healthy Participants

Study ID

NCT07498270

Start date

Jun 5, 2026

Status verified date

Jun, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
  • History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG, or family history of treatment resistant epilepsy except for a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
  • Possible pregnancy or plan to become pregnant in the next 6 months (self reported)
  • Any metal in the head
  • Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator)
  • Dental implants
  • Permanent retainers
  • Any hair braid, dreadlocks, hair pieces, or extensions which cannot be taken out before the study sessions
  • Any head coverings or headdress that participant feels uncomfortable removing for the purposes of study sessions
  • Any medication that may alter seizure threshold taken during the study i.e., ADHD stimulants (Adderall, amphetamine); Tricyclic/atypical antidepressants (amitriptyline, doxepine, imipramine, maprotiline, nortriptyline, bupropion); SSRIs (Escitalopram, Fluoxetine, Sertraline); Antipsychotics (chlorpromazine, clozapine), Bronchodilators (theophylline, aminophylline); Antibiotics (fluoroquinolones, imipenem, penicillin, cephalosporins, metronidazole, isoniazid); Antivirals (valacyclovir, ritonavir); OTC antihistamines (diphenhydramine, Benadryl)
  • Claustrophobia (a fear of small or closed places)
  • Back problems that would prevent lying flat for up to two hours
  • Regular night-shift work (second or third shift)
  • Sleep apnea or other sleep disorder (self-reported)

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Magnetic Resonance Imaging (MRI)

MRI is to optimize placement of uni- or multipolar TI-TES

Broad thalamic stimulation (TI-TES)

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

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)

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)

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.

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 ]
  • Change in SFA by Location [ Time Frame: during each of the 3 overnight visits, 5 weeks ]
  • Spindle Density in slow (8-12 Hz) and fast (13-16 Hz) SFA [ Time Frame: during each of the 3 overnight visits, 5 weeks ]
  • Spindle Amplitude in slow (8-12 Hz) and fast (13-16 Hz) SFA [ Time Frame: during each of the 3 overnight visits, 5 weeks ]
  • Spindle Duration in slow (8-12 Hz) and fast (13-16 Hz) SFA [ Time Frame: during each of the 3 overnight visits, 5 weeks ]
  • Spindle Topography in slow (8-12 Hz) and fast (13-16 Hz) SFA [ Time Frame: during each of the 3 overnight visits, 5 weeks ]

Central Contacts and Locations

Central contacts

Sean Prahl

608-263-4313capti@psychiatry.wisc.edu

Locations

Wisconsin Institute for Sleep and Consciousness

Recruiting

Madison, Wisconsin, United States, 53719

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Aug 10, 2026

Last verified

Jun, 2026

Keywords

  • sleep
  • spindles
  • non-rapid eye movement
  • SSD
  • neurobiology
  • impairment
  • brain stimulation
  • non-invasive stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-08-10.