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NCT07219719PHASE1RecruitingAccepts Healthy Volunteers

Temporal Interference for Thalamocortical Activity and Network Modulation

University of Wisconsin, Madison

Start Date

12/1/2025

Completion Date

11/1/2027

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

Detailed 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 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).

Eligibility Criteria

Age Range: 18 years to 50 years

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)

Interventions

DEVICE

Temporal Interference Transcranial electrical stimulation (TI-TES)

DEVICE

Sham stimulation

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Conditions

Healthy Participants

Locations

University of Wisconsin - Madison

Madison, Wisconsin 53705

United States