Mechanistic Validation of Human Multipolar TES-TI: Amplitude Modulation, Frequency, and Benchmarking (MINT)
8. september 2026 opdateret af: University of Wisconsin, Madison
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
24
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: MINT Study Team
- Telefonnummer: 608-263-4313
- E-mail: mint@psychiatry.wisc.edu
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53706
- University of Wisconsin - Madison
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Session A: Amplitude Modulation Specificity
hdEEG setup; eyes-closed wakefulness 4 conditions in randomized order:
Adverse events assessment |
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)
Andre navne:
|
|
Eksperimentel: Session B: Benchmarking
hdEEG setup; eyes-closed wakefulness 4 conditions in randomized order:
Adverse events assessment |
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)
Andre navne:
|
|
Eksperimentel: Session C: Frequency Dependence
hdEEG setup; eyes-closed wakefulness 4 conditions in randomized order:
Adverse events assessment |
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)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in band-limited, topography-resolved EEG spectral power during stimulation for conditions in Session A
Tidsramme: 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 (STIM-PRE) for in-phase mTI compared to SHAM, HF control, and the mixed unipolar+HF condition.
|
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
Tidsramme: 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 (STIM-PRE) for in-phase mTI compared to unipolar TES-TI at 5 mA, and 8 mA, relative to SHAM.
|
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
Tidsramme: 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)
|
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.
|
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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in band-limited, topography-resolved EEG spectral power in the post-stimulation interval (POST-PRE) across all tested conditions
Tidsramme: 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)
|
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.
|
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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Larissa Albantakis, PhD, UW School of Medicine and Public Health
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. februar 2028
Studieafslutning (Anslået)
1. februar 2028
Datoer for studieregistrering
Først indsendt
3. august 2026
Først indsendt, der opfyldte QC-kriterier
3. august 2026
Først opslået (Faktiske)
7. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026-1006
- Protocol Version (Anden identifikator: UW Madison)
- SMPH | Psychiatry (Anden identifikator: UW Madison)
- R&D funding (Andet bevillings-/finansieringsnummer: UW Madison Dept. of Psychiatry)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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.
IPD-delingstidsramme
after primary outcomes are published
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .