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Healthy ParticipantsPhase 1TITANNCT07219719

Temporal Interference for Thalamocortical Activity and Network Modulation

A Phase 1 study testing Temporal Interference Transcranial electrical stimulation (TI-TES) in people with 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

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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
Temporal Interference Transcranial electrical stimulation (TI-TES)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
1 Dec 2025to Apr 2028
Phase
Phase 1
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

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., 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)

Trial locations and contacts

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

TITAN Study Team contact

6082634313

titan@psychiatry.wisc.edu

Larissa Albantakis, PhD contact

United States1 site, 1 recruiting

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53705

    TITAN Study Team, 608-263-4313, titan@psychiatry.wisc.edu

    Recruiting

Other trials in United States

About this study

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
Read the 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).

Being tested
Temporal Interference Transcranial electrical stimulation (TI-TES), Sham stimulation

What participants receive

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

  • 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.

  • Sham stimulationDevice

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

Study groups in NCT07219719
Study groupRoleWhat they receive
StimulationExperimentalParticipants will complete two stimulation phases-overnight TI-TES during non-rapid eye movement (NREM) sleep and TI-TES during quiet wakefulness
Receives: Device: Temporal Interference Transcranial electrical stimulation (TI-TES)
Sham stimulationSham comparator~10 participants will be assigned to sham stimulation
Receives: Device: Sham stimulation

What is being measured

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

  1. 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.

    Measured: Pre- to post-intervention, up to 2 weeks

  2. Difference in magnitude of FC changes between sleep and wake

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

    Measured: 8 weeks

  3. 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.

    Measured: 8 weeks

Secondary outcomes (9)

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

    Sigma band power will be measured with high density EEG (hdEEG) during stimulation, and will be analyzed to quantify stimulation-related changes in sigma-band power during NREM sleep.

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

  2. Change in alpha band power during wake stimulation sessions

    Alpha band power will be measured with hdEEG during stimulation, and will be analyzed to quantify stimulation-related changes in alpha-band power during quiet wakefulness stimulation.

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

  3. Return to baseline thalamocortical FC

    After the ≥4-week washout, thalamocortical FC will be assessed by resting-state fMRI prior to the second stimulation phase.

    Measured: 8 weeks

  4. Change in structural thalamocortical connectivity

    Will be measured using diffusion-weighted imaging (DWI) in each phase.

    Measured: Pre- to post-intervention, up to 2 weeks

  5. Change in mood

    Mood will be scored using Positive and Negative Affect Schedule (PANAS). PANAS is a 20 item questionnaire, each item is rated on a 5-point scale, with 1 = "Very slightly or not at all" and 5 = "Extremely". To score PANAS, sum the scores for the 10 Positive Affect (PA) items and the 10 Negative Affect (NA) items separately on the 5-point scale. Higher scores for PA indicate a greater degree of positive emotion, while higher scores for NA indicate more negative emotion, with both scales ranging from 10 (low affect) to 50 (high affect).

    Measured: Baseline to 12 weeks

  6. Change in Boston Cognitive Assessment (BoCA)

    BoCA™ evaluates eight cognitive domains using randomized, non-repeating tasks to minimize practice effects. The total maximum score is 30. Higher scores indicate better cognitive performance.

    Measured: Baseline to 12 weeks

  7. Change in spindle characteristics: Density

    HdEEG will be analyzed to assess stimulation-related changes in spindle density during NREM sleep.

    Measured: Up to 1 week

  8. Change in spindle characteristics: Amplitude

    HdEEG will be analyzed to assess stimulation-related changes in spindle amplitude during NREM sleep.

    Measured: Up to 1 week

  9. Change in spindle characteristics: Duration

    HdEEG will be analyzed to assess stimulation-related changes in spindle duration during NREM sleep.

    Measured: Up to 1 week

Timeline

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

  1. First posted22 Oct 2025
  2. Study start1 Dec 2025
  3. Primary completionMar 2028 (estimated)
  4. Study completionApr 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 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
This pilot study employs a within-subject, counterbalanced crossover design in which each participant serves as their own control.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07219719
Sponsor's protocol ID
2025-1275
Other IDs
SMPH/PSYCHIATRY/PSYCHIATRY, Protocol Version 9/9/2026
Acronym
TITAN
Status last verified
Sep 2026
First submitted
16 Oct 2025
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Temporal Interference Transcranial electrical stimulation (TI-TES) in people with 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 4 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 1 Oct 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 TITAN Study Team (6082634313, titan@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 thalamocortical functional connectivity (FC): resting state fMRI (time frame: Pre- to post-intervention, up to 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07219719.

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 1 Oct 2026.

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