Temporal Interference for Thalamocortical Activity and Network Modulation

NCT07219719 | Recruiting Phase 1 DMC FDA Device

• 3 other identifiers: 2025-1275SMPH/PSYCHIATRY/PSYCHIATRYProtocol Version 3/24/2026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Change in thalamocortical functional connectivity (FC): resting state fMRI

  Resting-state fMRI will be used to assess changes in thalamocortical functional connectivity before and after repeated thalamic TI-TES delivered during NREM sleep and quiet wakefulness.

  Pre- to post-intervention, up to 2 weeks

• Difference in magnitude of FC changes between sleep and wake

  The magnitude of FC changes between sleep and wake stimulation phases will be evaluated.

  8 weeks

• Difference in spatial distribution of FC changes between sleep and wake

  The spatial distribution of FC changes between sleep and wake stimulation phases will be evaluated.

  8 weeks

Secondary Outcomes (9)

• Change in sigma-band power (EEG, sleep phase)

  During and after each overnight stimulation session, up to 1 week

• Change in alpha band power during wake stimulation sessions

  During and after each wake stimulation session, up to 1 week

• Return to baseline thalamocortical FC

  8 weeks

• Change in structural thalamocortical connectivity

  Pre- to post-intervention, up to 2 weeks

• Change in mood

  Baseline to 12 weeks

Study Arms (2)

Stimulation

EXPERIMENTAL

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

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

Sham stimulation

SHAM COMPARATOR

\~10 participants will be assigned to sham stimulation

Device: Sham stimulation

Interventions

Temporal Interference Transcranial electrical stimulation (TI-TES) DEVICE

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.

Stimulation

Sham stimulation DEVICE

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

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

RECRUITING

Study Officials

• Larissa Albantakis, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean Prahl

CONTACT

262-395-8675; titan@psychiatry.wisc.edu

Larissa Albantakis, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This pilot study employs a within-subject, counterbalanced crossover design in which each participant serves as their own control.

Study Record Dates

• First Submitted: October 16, 2025
• First Posted: October 22, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)