Location- and Frequency-Dependent Effects of Thalamic Temporal Interference Stimulation During Sleep

NCT07498270 | Recruiting FDA Device

• 4 other identifiers: 2026-0034SMPH | PsychiatryProtocol Version 4/9/26R21MH141540
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Change in Spectral Power (SFA) for Active TI-TES vs SHAM

  Comparing active TI-TES vs carrier only SHAM, evaluated using both STIM-PRE and POST-PRE contrasts.

  during each of the 3 overnight visits, 5 weeks

• Change in SFA by Location

  Changes in 8-16 Hz spectral power across frequency-location combinations (broad thalamic, anterior thalamic, posterior thalamic) for STIM-PRE and POST-PRE to identify the most effective parameters within the tested parameter space.

  during each of the 3 overnight visits, 5 weeks

• Spindle Density in slow (8-12 Hz) and fast (13-16 Hz) SFA

  Changes in slow (8-12 Hz) and fast (13-16 Hz) spindle characteristics (density) using STIM-PRE and POST-PRE contrasts

  during each of the 3 overnight visits, 5 weeks

• Spindle Amplitude in slow (8-12 Hz) and fast (13-16 Hz) SFA

  Changes in slow (8-12 Hz) and fast (13-16 Hz) spindle characteristics (amplitude) using STIM-PRE and POST-PRE contrasts

  during each of the 3 overnight visits, 5 weeks

• Spindle Duration in slow (8-12 Hz) and fast (13-16 Hz) SFA

  Changes in slow (8-12 Hz) and fast (13-16 Hz) spindle characteristics (duration) using STIM-PRE and POST-PRE contrasts

  during each of the 3 overnight visits, 5 weeks

• Spindle Topography in slow (8-12 Hz) and fast (13-16 Hz) SFA

  Changes in slow (8-12 Hz) and fast (13-16 Hz) spindle characteristics (topography) using STIM-PRE and POST-PRE contrasts

  during each of the 3 overnight visits, 5 weeks

Secondary Outcomes (6)

• Change in Spectral Power (SFA) for SHAM during slow vs fast conditions

  during each of the 3 overnight visits, 5 weeks

• Changes in slow-wave spectral power (0.5-4.0 Hz) relative to SHAM

  during each of the 3 overnight visits, 5 weeks

• Changes in Slow-wave Density

  during each of the 3 overnight visits, 5 weeks

• Changes in Slow-wave Amplitude

  during each of the 3 overnight visits, 5 weeks

• Changes in Slow-wave Duration

  during each of the 3 overnight visits, 5 weeks

Other Outcomes (1)

• Changes in directed hdEEG functional connectivity

  during each of the 3 overnight visits, 5 weeks

Study Arms (1)

All Participants

EXPERIMENTAL

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.

Other: Magnetic Resonance Imaging (MRI); Device: Broad thalamic stimulation (TI-TES); Device: Carrier only SHAM stimulation; Device: Anterior thalamic stimulation (TI-TES); Device: Posterior thalamic stimulation (TI-TES)

Interventions

Magnetic Resonance Imaging (MRI) OTHER

MRI is to optimize placement of multipolar TI-TES

Also known as: structural MRI

All Participants

Broad thalamic stimulation (TI-TES) DEVICE

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

All Participants

Carrier only SHAM stimulation DEVICE

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

All Participants

Anterior thalamic stimulation (TI-TES) DEVICE

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

All Participants

Posterior thalamic stimulation (TI-TES) DEVICE

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.

All Participants

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

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., 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Wisconsin Institute for Sleep and Consciousness

Madison, Wisconsin, 53719, United States

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Larissa Albantakis, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean Prahl

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. Phase 1 will include approximately 10 participants and will test 10 Hz, 14 Hz, and matched carrier-only SHAM across all locations. Contingent on Phase 1 data, Phase 2 will include approximately 10 participants and will expand frequencies across 8-16 Hz or retain only 10 Hz and 14 Hz (plus SHAM) if effect sizes are smaller than anticipated.

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)