Mechanistic Validation of Human Multipolar TES-TI: Amplitude Modulation, Frequency, and Benchmarking

NCT07752745 | Not Yet Recruiting FDA Device

• 4 other identifiers: 2026-1006R&D fundingProtocol VersionSMPH | Psychiatry
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Transcranial Electric Stimulation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  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)

Study Arms (3)

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

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

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

Device: TES-TI with hdEEG

Interventions

TES-TI with hdEEG DEVICE

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)

Also known as: mTI, transcranial electrical stimulation, High-Density Electroencephalography

Session A: Amplitude Modulation Specificity; Session B: Benchmarking; Session C: Frequency Dependence

Eligibility Criteria

• Age: 18 Years - 50 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:

• 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
• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53706, United States

Location

Related Links

• Larissa Albantakis, PhD

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Larissa Albantakis, PhD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MINT Study Team

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within-subject, single-blind, randomized, counterbalanced crossover design in which each participant serves as their own control.

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after primary outcomes are published

Locations

US (1)