Recruiting
Phase 1

Temporal Interference Stimulation

Sponsor:

University of Wisconsin, Madison

Code:

NCT07219719

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Temporal Interference Transcranial electrical stimulation (TI-TES)

Sham stimulation

Study Details

Brief summary:

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:

  • Complete two stimulation phases - overnight and during wakefulness
  • Undergo two MRIs per study phase

Conditions

Healthy Participants

Study ID

NCT07219719

Start date

Dec 1, 2025

Status verified date

Sep, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adults aged 18-50
  • Medically healthy
  • U.S. citizen or holding permanent resident status
  • English-speaking

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., Attention-deficit/hyperactivity disorder (ADHD) stimulants (Adderall, amphetamine); Tricyclic/atypical antidepressants (amitriptyline, doxepin, imipramine, maprotiline, nortriptyline, bupropion); SSRIs (Escitalopram, Fluoxetine, Sertraline); Antipsychotics (chlorpromazine, clozapine), Bronchodilators (theophylline, aminophylline); Antibiotics (fluoroquinolones, imipenem, penicillin, cephalosporins, metronidazole, isoniazid); Antivirals (valacyclovir, ritonavir); over the counter antihistamines (diphenhydramine, Benadryl); Estradiol-based birth control
  • 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

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Stimulation

Participants will complete two stimulation phases-overnight TI-TES during non-rapid eye movement (NREM) sleep and TI-TES during quiet wakefulness

sham comparator: Sham stimulation

\~10 participants will be assigned to sham stimulation

Interventions

Temporal Interference Transcranial electrical stimulation (TI-TES)

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.

Sham stimulation

Sham (ramp only) stimulation will briefly ramp up and down at the beginning and end of each stimulation train, without delivering continuous stimulation throughout.

Primary outcome measure

  • Change in thalamocortical functional connectivity (FC): resting state fMRI [ Time Frame: Pre- to post-intervention, up to 2 weeks ]
  • Difference in magnitude of FC changes between sleep and wake [ Time Frame: 8 weeks ]
  • Difference in spatial distribution of FC changes between sleep and wake [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

TITAN Study Team

6082634313titan@psychiatry.wisc.edu

Locations

University of Wisconsin - Madison

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

TITAN Study Team

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

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.