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

2026年9月8日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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:

  1. 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).
  2. 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.

  3. 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:

  4. 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

研究の種類

介入

入学 (推定)

24

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Wisconsin
      • Madison、Wisconsin、アメリカ、53706
        • University of Wisconsin - Madison

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：基礎科学
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：Session A: Amplitude Modulation Specificity

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
デバイス：TES-TI with hdEEG
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)
他の名前：
  • 経頭蓋電気刺激
  • mTI
  • High-Density Electroencephalography
実験的：Session B: Benchmarking

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
デバイス：TES-TI with hdEEG
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)
他の名前：
  • 経頭蓋電気刺激
  • mTI
  • High-Density Electroencephalography
実験的：Session C: Frequency Dependence

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
デバイス：TES-TI with hdEEG
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)
他の名前：
  • 経頭蓋電気刺激
  • mTI
  • High-Density Electroencephalography

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in band-limited, topography-resolved EEG spectral power during stimulation for conditions in Session A
時間枠：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
時間枠：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
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in band-limited, topography-resolved EEG spectral power in the post-stimulation interval (POST-PRE) across all tested conditions
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Wisconsin, Madison

捜査官

  • 主任研究者：Larissa Albantakis, PhD、UW School of Medicine and Public Health

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2028年2月1日

研究の完了 (推定)

2028年2月1日

試験登録日

最初に提出

2026年8月3日

QC基準を満たした最初の提出物

2026年8月3日

最初の投稿 (実際)

2026年8月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月11日

QC基準を満たした最後の更新が送信されました

2026年9月8日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 2026-1006
  • Protocol Version (その他の識別子：UW Madison)
  • SMPH | Psychiatry (その他の識別子：UW Madison)
  • R&D funding (その他の助成金/資金番号：UW Madison Dept. of Psychiatry)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

after primary outcomes are published

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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