Transcranial Electric StimulationMINTNCT07752745
Mechanistic Validation of Human Multipolar TES-TI: Amplitude Modulation, Frequency, and Benchmarking
A study testing TES-TI with hdEEG in people with Transcranial Electric Stimulation, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study is to find out whether and how a type of non-invasive electrical brain stimulation called transcranial electrical stimulation with temporal interference (TES-TI) can temporarily change brain activity in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcranial Electric Stimulation
- What is being tested?
- TES-TI with hdEEG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2026to Feb 2028
- Phase
- Interventional
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
- 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
- Current or past history of clinically significant neurological disorder or acquired neurological disease (e.g., stroke, traumatic brain injury), including intracranial lesions (including clinically significant findings identified on the structural MRI)
- History of inpatient psychiatric hospitalization
- History of head trauma resulting in prolonged loss of consciousness; or a history of >3 grade I concussions
- Current poorly controlled headaches, including intractable or frequent 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
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- Possible pregnancy or plan to become pregnant in the next 6 months (self reported)
- Any metal in the head or body
- 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
- Current use of medications known to substantially lower seizure threshold, specifically chlorpromazine, clozapine, bupropion, clomipramine, or maprotiline; or other medications at doses known to substantially lower seizure threshold in the judgment of the PI
- Active scalp lesions, broken skin, or skin conditions at planned electrode sites that would preclude safe electrode application
- Claustrophobia (a fear of small or closed places)
- Back problems that would prevent lying flat for up to two hours
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
- Recruiting
University of Wisconsin - Madison
Madison, Wisconsin, 53706
About this study
This study is to find out whether and how a type of non-invasive electrical brain stimulation called transcranial electrical stimulation with temporal interference (TES-TI) can temporarily change brain activity in healthy adults. A structural MRI scan will be used to customize where the stimulation electrodes are placed for each participant to deliver TES-TI during three afternoon sessions at rest with eyes closed. Brain activity is recorded with high-density EEG. Up to 24 participants will be enrolled and on study for 3 to 12 weeks.
Read the detailed description
This is an experimental study using a within-subject, single-blind, randomized, counterbalanced crossover design in which each participant serves as their own control. Healthy adults will complete (or provide an existing) structural MRI scan (T1/T2) to support individualized electric-field modeling and personalized montage optimization for thalamic targeting, followed by three afternoon stimulation sessions with simultaneous high-density EEG during eyes-closed wakefulness; sessions will be scheduled on separate days at least one week apart. Each session includes four stimulation conditions administered in randomized/counterbalanced order, with each condition consisting of a fixed 3-minute pre-stimulation baseline, 3-minute stimulation period, and 3-minute post-stimulation recording to enable STIM-PRE and POST-PRE comparisons.
- Session A tests amplitude-modulation specificity (in-phase mTI, a mixed unipolar+HF condition with the same montage/current, a carrier-only HF control, and sham)
- Session B benchmarks in-phase mTI against unipolar TES-TI at 5 mA and 8 mA (plus sham); and
- Session C characterizes frequency dependence of in-phase mTI (10, 50, 130 Hz; plus sham).
Primary Objectives:
- Determine whether active multipolar TES-TI (mTI) produces envelope-driven EEG effects (primary contrast: STIM-PRE) by comparing in-phase mTI to SHAM, to a carrier-only no-envelope high-frequency (HF) control, and to a mixed unipolar+HF condition (same montage/current; one pair as unipolar TES-TI producing an AM envelope, the other pair as a non-interacting HF carrier with no envelope contribution).
- Benchmark mTI against unipolar TES-TI across stimulation intensity by comparing in-phase mTI to unipolar TES-TI at 5 mA and 8 mA, each evaluated relative to SHAM (primary contrast: STIM-PRE), and estimating effect sizes to inform future study design.
- Characterize envelope-frequency dependence of in-phase mTI effects by comparing EEG spectral power changes across 10, 50, and 130 Hz conditions (each relative to SHAM; primary contrast: STIM-PRE). Secondary Objectives:
- Assess persistence of stimulation-related EEG changes by quantifying post-stimulation effects (POST-PRE) across conditions (in-phase, mixed unipolar+HF, HF, unipolar) and sessions
- Conditions
- Transcranial Electric Stimulation
- Being tested
- TES-TI with hdEEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TES-TI with hdEEGDevice
Also called mTI, transcranial electrical stimulation, High-Density Electroencephalography
4 conditions per session. Each condition will follow a standardized block structure consisting of 3 minutes pre-stimulation baseline, 3 minutes stimulation, and 3 minutes post-stimulation recording (PRE, STIM, POST)
| Study group | Role | What they receive |
|---|---|---|
| Session A: Amplitude Modulation Specificity | Experimental | hdEEG setup; eyes-closed wakefulness 4 conditions in randomized order:
* in-phase mTI (10 Hz)
* mixed unipolar+HF
* HF control (no envelope)
* SHAM PRE 3 min / STIM 3 min / POST 3 min per condition
Adverse events assessment Receives: Device: TES-TI with hdEEG |
| Session B: Benchmarking | Experimental | hdEEG setup; eyes-closed wakefulness 4 conditions in randomized order:
* in-phase mTI (10 Hz)
* unipolar TES-TI 5 mA
* unipolar TES-TI 8 mA
* SHAM PRE 3 min / STIM 3 min / POST 3 min per condition
Adverse events assessment Receives: Device: TES-TI with hdEEG |
| Session C: Frequency Dependence | Experimental | hdEEG setup; eyes-closed wakefulness 4 conditions in randomized order:
* in-phase mTI at 10 Hz
* in-phase mTI at 50 Hz
* in-phase mTI at 130 Hz
* SHAM PRE 3 min / STIM 3 min / POST 3 min per condition
Adverse events assessment Receives: Device: TES-TI with hdEEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in band-limited, topography-resolved EEG spectral power during stimulation for conditions in Session A
Change in band-limited, topography-resolved EEG spectral power during stimulation (STIM-PRE) for in-phase mTI compared to SHAM, HF control, and the mixed unipolar+HF condition.
Measured: data collected for 3 minutes prior to stimulation and 3 minutes during stimulation for each of 4 conditions during Session A (approximately 3 hours long)
Change in band-limited, topography-resolved EEG spectral power during stimulation for conditions in Session B
Change in band-limited, topography-resolved EEG spectral power during stimulation (STIM-PRE) for in-phase mTI compared to unipolar TES-TI at 5 mA, and 8 mA, relative to SHAM.
Measured: data collected for 3 minutes prior to stimulation and 3 minutes during stimulation for each of 4 conditions during Session B (approximately 3 hours long)
Change in band-limited, topography-resolved EEG spectral power during stimulation for conditions in Session C
Change in band-limited, topography-resolved EEG spectral power during stimulation (STIM-PRE) for in-phase mTI at 10 Hz, 50 Hz, and 130 Hz, relative to SHAM.
Measured: data collected for 3 minutes prior to stimulation and 3 minutes during stimulation for each of 4 conditions during Session C (approximately 3 hours long)
Secondary outcomes (1)
Change in band-limited, topography-resolved EEG spectral power in the post-stimulation interval (POST-PRE) across all tested conditions
Change in band-limited, topography-resolved EEG spectral power in the post-stimulation interval (POST-PRE) across all tested conditions (in-phase mTI, mixed unipolar+HF, HF control, unipolar 5 mA, unipolar 8 mA; and 10/50/130 Hz where applicable), each evaluated relative to SHAM.
Measured: data collected for 3 minutes prior to stimulation and 3 minutes post stimulation for each of 4 conditions during each of 3 sessions (each session is approximately 3 hours long, with at least one week between sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start9 Oct 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Electric StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Crossover
- Model description
- Within-subject, single-blind, randomized, counterbalanced crossover design in which each participant serves as their own control.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Larissa Albantakis, PhD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752745
- Sponsor's protocol ID
- 2026-1006
- Other IDs
- R&D funding, Protocol Version 1.0, SMPH | Psychiatry
- Acronym
- MINT
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: In accordance with UW-Madison data-sharing expectations, the study team intends to support sharing of de-identified scientific data collected during this project to the extent feasible. Sharing, if performed, will occur after the primary outcome results are published and may take the form of deposit in a controlled-access scientific repository, release on an open-access scientific data platform (e.g., OpenNeuro or similar), or response to requests from qualified researchers. The choice of sharing mechanism, repository, and timing will be determined by the study team consistent with funder requirements, UW-Madison policy, and participant consent, and it is possible that no sharing will occur if none of these options is consistent with those requirements.