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Healthy Adult ParticipantsCAP-TINCT07498270

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

A study testing Magnetic Resonance Imaging (MRI), Broad thalamic stimulation (TI-TES) and Anterior thalamic stimulation (TI-TES) in people with Healthy Adult Participants and Healthy Participants, run by University of Wisconsin, Madison at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
What is being tested?
Magnetic Resonance Imaging (MRI), Broad thalamic stimulation (TI-TES) and Anterior thalamic stimulation (TI-TES)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteUnited States
Study dates
5 Jun 2026to Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 18Show fewer
  • 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)
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Wisconsin Institute for Sleep and Consciousness

    Madison, Wisconsin, 53719

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

This single-site, single-blind, experimental study will test whether thalamic temporal interference transcranial electrical stimulation (TI-TES) delivered during Non-Rapid Eye Movement (NREM) sleep can enhance spindle-frequency activity (SFA) in healthy adults and identify optimal stimulation parameters across frequency and thalamic target location.

After screening/consent, participants will complete a structural MRI for personalized montage optimization, then undergo three overnight High-Density Electroencephalography (hdEEG) and Polysomnography (PSG) sleep sessions (10-12 hours each) in a randomized, counterbalanced crossover design, one session per stimulation location (broad thalamic, anterior thalamic, posterior thalamic). During stable N2 sleep, TI-TES will be delivered in 3-minute epochs separated by 6-minute intervals, for up to 24 epochs per night, under real-time sleep-technician monitoring. The study uses a two-phase frequency plan: Phase 1 (~10 participants) will test 10 Hz, 14 Hz, and matched carrier-only SHAM; contingent on feasibility/sensitivity, Phase 2 (~10 participants) will expand frequencies across 8-16 Hz. Primary outcomes quantify stimulation-related increases in 8-16 Hz spectral power (SFA) and spindle characteristics comparing active TI-TES versus SHAM and across stimulation locations/frequencies.

Primary Objectives:

  1. Determine whether active thalamic TI-TES increases 8-16 Hz spindle-frequency activity (SFA) relative to carrier-only SHAM (evaluated using STIM-PRE and POST-PRE contrasts).
  2. Identify the most effective TI-TES stimulation parameters across stimulation frequencies and stimulation locations (broad thalamic, anterior, posterior) by comparing SFA changes across parameter combinations.
  3. Characterize stimulation-related changes in spindle characteristics (density, amplitude, duration, topography) for slow and fast spindle subtypes. Secondary Objectives:
  4. Evaluate stimulation-related changes in slow (8-12 Hz) and fast (13-16 Hz) spindle spectral power.
  5. Evaluate stimulation-related changes in slow wave (0.5-4.0 Hz) spectral power.
  6. Characterize stimulation-related changes in slow-wave characteristics (density, amplitude, duration).
  7. Evaluate stimulation-related changes in SO-spindle coupling (phase-amplitude coupling) for slow and fast spindles.
  8. (Exploratory) Evaluate stimulation-related changes in hdEEG functional connectivity between channels using the phase slope index (PSI).
Being tested
Magnetic Resonance Imaging (MRI), Broad thalamic stimulation (TI-TES), Carrier only SHAM stimulation, Anterior thalamic stimulation (TI-TES), Posterior thalamic stimulation (TI-TES)
Keywords
sleep, spindles, non-rapid eye movement, SSD, neurobiology, impairment, brain stimulation, non-invasive stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic Resonance Imaging (MRI)Other

    Also called structural MRI

    MRI is to optimize placement of uni- or multipolar TI-TES

  • 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

  • Carrier only SHAM stimulationDevice

    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

  • 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

  • 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.

Study groups in NCT07498270
Study groupRoleWhat they receive
All ParticipantsExperimentalParticipants 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.
Receives: 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: during each of the 3 overnight visits, 5 weeks

  2. 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.

    Measured: during each of the 3 overnight visits, 5 weeks

  3. 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

    Measured: during each of the 3 overnight visits, 5 weeks

  4. 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

    Measured: during each of the 3 overnight visits, 5 weeks

  5. 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

    Measured: during each of the 3 overnight visits, 5 weeks

  6. 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

    Measured: during each of the 3 overnight visits, 5 weeks

Secondary outcomes (6)
  1. Change in Spectral Power (SFA) for SHAM during slow vs fast conditions

    Changes in slow (8-12 Hz) and fast (13-16 Hz) spectral power relative to SHAM

    Measured: during each of the 3 overnight visits, 5 weeks

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

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

    Measured: during each of the 3 overnight visits, 5 weeks

  3. Changes in Slow-wave Density

    Changes in slow-wave characteristics (density) in STIM-PRE and POST-PRE contrasts.

    Measured: during each of the 3 overnight visits, 5 weeks

  4. Changes in Slow-wave Amplitude

    Changes in slow-wave characteristics (amplitude) in STIM-PRE and POST-PRE contrasts.

    Measured: during each of the 3 overnight visits, 5 weeks

  5. Changes in Slow-wave Duration

    Changes in slow-wave characteristics (duration) in STIM-PRE and POST-PRE contrasts.

    Measured: during each of the 3 overnight visits, 5 weeks

  6. Changes in Spindle and Slow Oscillation Coupling

    Changes in SO-Spindle coupling, quantified via phase-amplitude coupling metrics

    Measured: during each of the 3 overnight visits, 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start5 Jun 2026
  3. Primary completionAug 2027 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07498270
Sponsor's protocol ID
2026-0034
Other IDs
R21MH141540, SMPH | Psychiatry, Protocol Version 6/1/26
Acronym
CAP-TI
Status last verified
Jun 2026
First submitted
23 Mar 2026
Last updated
10 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Magnetic Resonance Imaging (MRI), Broad thalamic stimulation (TI-TES) and Anterior thalamic stimulation (TI-TES) in people with Healthy Adult Participants and Healthy Participants, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sean Prahl (608-263-4313, capti@psychiatry.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Spectral Power (SFA) for Active TI-TES vs SHAM (time frame: during each of the 3 overnight visits, 5 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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