Temporal Interference for Thalamocortical Activity and Network Modulation (TITAN)

University of Wisconsin (UW)

Status and phase

Enrolling

Phase 1

Conditions

Healthy Participants

Treatments

Device: Temporal Interference Transcranial electrical stimulation (TI-TES)

Study type

Interventional

Funder types

Other

Identifiers

NCT07219719

Protocol Version 10/20/25 (Other Identifier)

SMPH/PSYCHIATRY/PSYCHIATRY (Other Identifier)

2025-1275

Details and patient eligibility

About

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

Full description

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 during NREM sleep and (2) repeated TI-TES 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).

Enrollment

30 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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); Antipsychotics (chlorpromazine, clozapine), Bronchodilators (theophylline, aminophylline); Antibiotics (fluoroquinolones, imipenem, penicillin, cephalosporins, metronidazole, isoniazid); Antivirals (valacyclovir, ritonavir); over the counter 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)