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Temporal Interference Methods for Non-invasive Deep Brain Stimulation, Study 1.3

2026年9月8日 更新者:Joshua Brown, PHD、Indiana University

Temporal Interference Methods for Non-invasive Deep Brain Stimulation

This grant aims to develop a line of research using temporal interference (TI) electrical neurostimulation technology to understand the causal role of deep brain structures in cognition. In the short term, the investigators aim to validate and characterize the effects of TI on brain activity as measured by fMRI and demonstrate its ability to focally stimulate deep brain regions without affecting overlying cortex. In the longer term, investigators aim to use these data to resolve longstanding debates about the function of deeper brain regions and lay the foundation for future clinical applications of TI for treating addiction, Obsessive-Compulsive Disorder (OCD), Parkinson's disease, and other disorders involving deep brain dysfunction. The grant supports 2 distinct aims, each of which will be evaluated through a series of independent studies.

調査の概要

詳細な説明

Through the grant's duration, the investigators hypothesize that temporal interference (TI) electrical neurostimulation will be well tolerated and effective at focally manipulating deep brain activity as measured by functional MRI (fMRI) BOLD signals. The investigators will investigate whether TI stimulation can increase BOLD activity in targeted deep brain regions including the nucleus accumbens (NAcc) and dorsal anterior cingulate cortex (dACC), and whether this stimulation can influence cognitive functions controlled by these regions. TI works by applying alternating currents of slightly different frequencies through multiple electrode pairs, creating an interference pattern that can stimulate deep brain regions without significantly affecting superficial cortical areas. This method is similar to traditional transcranial direct current stimulation (tDCS), however TI can stimulate deeper brain structures that tDCS cannot reach effectively. The study is broken up into two main aims with multiple sub-studies. In Aim 1, the investigators will characterize the effects of TI on fMRI BOLD signals, test different beat frequencies, and compare TI effects in the nucleus accumbens versus dorsal anterior cingulate cortex. In Aim 2, the investigators will apply TI to the dorsal anterior cingulate cortex to test causal theories about its role in cognitive control, conflict monitoring, risk avoidance, and foraging behavior using established cognitive tasks while subjects undergo fMRI scanning.

Study 1.3 (Aim 1, Study 1.3) will test whether TI can focally modulate activity in the dorsal anterior cingulate cortex, around MNI coordinates 0, 30, 30, as measured by fMRI BOLD signal. Healthy subjects (n=30) will complete a single study visit during which they will undergo fMRI while receiving TI stimulation through carbon fiber electrodes attached to the scalp with conductive gel. Electrode placement may vary by participant to optimize dACC targeting using individualized finite element modeling.

Participants will receive active and sham TI stimulation at a selected beat frequency potentially including 5 Hz, 30 Hz, 40 Hz, or another frequency in the 1-100 Hz range. Stimulation will follow an on/off sequence of 2 minutes on, 2 minutes off, 2 minutes on, and 2 minutes off, with 30-second ramp up and ramp down periods beginning at the start of each 2-minute stimulation period. Study 1.3 will also examine whether increased stimulation intensity improves modulation of BOLD activity in the dACC. Stimulation may be delivered up to ±5 mA per channel, corresponding to 10 mA peak-to-peak, with the second stimulation channel linearly scaled based on individualized modeling to maintain optimal targeting. Active and sham stimulation blocks will be counterbalanced across subjects.

研究の種類

介入

入学 (推定)

30

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

  • 名前:Joshua W Brown, PhD
  • 電話番号:812-855-9282
  • メール:cclab@iu.edu

研究連絡先のバックアップ

  • 名前:Irene Jang, BS
  • 電話番号:812-856-1846
  • メール:cclabmgr@iu.edu

研究場所

    • Indiana
      • Bloomington、Indiana、アメリカ、47408
        • 募集
        • Indiana University Bloomington, Imaging Research Facility
        • コンタクト:
          • Josh W Brown, PhD
          • 電話番号:812-856-1846
          • メール:cclab@iu.edu
        • コンタクト:

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:

  • Between the ages of 18 and 50
  • Must have at least a 6th grade education
  • Ability to speak and read English for all phases

Exclusion Criteria:

  • Currently taking psychotropic medications for ADHD, other mental illness, or medications for cancer
  • History of epilepsy or seizure disorders
  • History of migraines or other neurological syndromes
  • History of AIDS (due to potential cognitive deficits)
  • History of head trauma or cognitive impairments
  • Personal experiences consistent with symptoms of psychosis (e.g., hallucinations, delusions of control or special powers)
  • History of skull defects (e.g., holes bored into the skull or known cranial fissures)
  • Metal implants in the head or under the scalp
  • Does not meet fMRI safety screening criteria (e.g., metal implants in the body, permanent jewelry, tattoos on the head or neck)
  • Uses an intrauterine device (IUD) for birth control and cannot provide documentation to verify MRI safety
  • Pregnancy (self-reported; no pregnancy test administered)
  • Weight over 440 lbs (scanner weight limit)
  • Presence of pacemakers

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
アクティブコンパレータ:dACC 20Hz Active then Sham; Comparison frequency Active then Sham
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using two pairs of carbon fiber electrodes in the following order: 20 Hz TI Active, 20 Hz TI Sham, selected comparison frequency TI Active, then selected comparison frequency TI Sham. The comparison frequency will be within the 1-100 Hz range.
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC 20 Hz TI Active condition, one channel will deliver 2000 Hz and the other 2020 Hz, producing a 20 Hz beat frequency targeting the dorsal anterior cingulate cortex. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
他の名前:
  • TI 電気神経刺激
  • TI 神経刺激
Same setup as the dACC 20 Hz TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
他の名前:
  • TI 電気神経刺激
  • TI 神経刺激
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC comparison frequency TI Active condition, stimulation will be delivered using a selected beat frequency in the 1-100 Hz range. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
他の名前:
  • TI 電気神経刺激
  • TI 神経刺激
Same setup as the dACC comparison frequency TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
他の名前:
  • TI 電気神経刺激
  • TI 神経刺激
アクティブコンパレータ:dACC 20Hz Sham then Active; Comparison Frequency Sham then Active
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: 20 Hz TI Sham, 20 Hz TI Active, selected comparison frequency TI Sham, then selected comparison frequency TI Active. The comparison frequency will be in the 1-100 Hz range.
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC 20 Hz TI Active condition, one channel will deliver 2000 Hz and the other 2020 Hz, producing a 20 Hz beat frequency targeting the dorsal anterior cingulate cortex. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
他の名前:
  • TI 電気神経刺激
  • TI 神経刺激
Same setup as the dACC 20 Hz TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
他の名前:
  • TI 電気神経刺激
  • TI 神経刺激
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC comparison frequency TI Active condition, stimulation will be delivered using a selected beat frequency in the 1-100 Hz range. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
他の名前:
  • TI 電気神経刺激
  • TI 神経刺激
Same setup as the dACC comparison frequency TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
他の名前:
  • TI 電気神経刺激
  • TI 神経刺激
アクティブコンパレータ:dACC Comparison Frequency Sham then Active; 20Hz Sham then Active
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: selected comparison frequency TI Sham, selected comparison frequency TI Active, 20 Hz TI Sham, then 20 Hz TI Active. The comparison frequency will be in the 1-100 Hz range.
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC 20 Hz TI Active condition, one channel will deliver 2000 Hz and the other 2020 Hz, producing a 20 Hz beat frequency targeting the dorsal anterior cingulate cortex. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
他の名前:
  • TI 電気神経刺激
  • TI 神経刺激
Same setup as the dACC 20 Hz TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
他の名前:
  • TI 電気神経刺激
  • TI 神経刺激
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC comparison frequency TI Active condition, stimulation will be delivered using a selected beat frequency in the 1-100 Hz range. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
他の名前:
  • TI 電気神経刺激
  • TI 神経刺激
Same setup as the dACC comparison frequency TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
他の名前:
  • TI 電気神経刺激
  • TI 神経刺激
アクティブコンパレータ:dACC Comparison Frequency Active then Sham; 20Hz Active then Sham
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: selected comparison frequency TI Active, selected comparison frequency TI Sham, 20 Hz TI Active, then 20 Hz TI Sham. The comparison frequency will be in the 1-100 Hz range.
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC 20 Hz TI Active condition, one channel will deliver 2000 Hz and the other 2020 Hz, producing a 20 Hz beat frequency targeting the dorsal anterior cingulate cortex. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
他の名前:
  • TI 電気神経刺激
  • TI 神経刺激
Same setup as the dACC 20 Hz TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
他の名前:
  • TI 電気神経刺激
  • TI 神経刺激
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC comparison frequency TI Active condition, stimulation will be delivered using a selected beat frequency in the 1-100 Hz range. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
他の名前:
  • TI 電気神経刺激
  • TI 神経刺激
Same setup as the dACC comparison frequency TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
他の名前:
  • TI 電気神経刺激
  • TI 神経刺激

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 brain activity in the dorsal anterior cingulate cortex during 20 Hz versus selected comparison frequency temporal interference stimulation
時間枠:During fMRI scan on study day (approximately 60 minutes)
Brain activity in the dorsal anterior cingulate cortex will be measured using functional magnetic resonance imaging (fMRI) during temporal interference (TI) stimulation at 20 Hz compared to a selected comparison beat frequency. The comparison frequency will be in the 1-100 Hz range. Activity will be reported as the percent change in blood-oxygen-level-dependent (BOLD) signal, which reflects changes in neural activity. Higher BOLD values indicate stronger brain activation.
During fMRI scan on study day (approximately 60 minutes)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in brain activity in the dorsal anterior cingulate cortex during active versus sham stimulation at 20 Hz
時間枠:During fMRI scan on study day (approximately 60 minutes)
Brain activity in the dorsal anterior cingulate cortex will be measured using fMRI during active versus sham temporal interference stimulation at a 20 Hz beat frequency. Activity will be reported as the percent change in blood-oxygen-level-dependent (BOLD) signal.
During fMRI scan on study day (approximately 60 minutes)
Change in brain activity in the dorsal anterior cingulate cortex during active versus sham stimulation at the selected comparison frequency
時間枠:During fMRI scan on study day (approximately 60 minutes)
Brain activity in the dorsal anterior cingulate cortex will be measured using fMRI during active versus sham temporal interference stimulation at the selected comparison beat frequency. The comparison frequency will be within the 1-100 Hz range. Activity will be reported as the percent change in blood-oxygen-level-dependent (BOLD) signal.
During fMRI scan on study day (approximately 60 minutes)
Change in brain connectivity between the dorsal anterior cingulate cortex and other brain regions during temporal interference stimulation
時間枠:During fMRI scan on study day (approximately 60 minutes)
Functional connectivity between the dorsal anterior cingulate cortex and other brain regions will be measured using fMRI-based analyses during active versus sham temporal interference stimulation. Higher correlation values indicate stronger communication between brain regions. The primary test statistic will be the whole-brain psychophysiological interaction (PPI) between dorsal anterior cingulate cortex BOLD activity and stimulation condition.
During fMRI scan on study day (approximately 60 minutes)

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

捜査官

  • 主任研究者:Joshua W Brown, PhD、Indiana University, Bloomington

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。

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 (実際)

2026年7月16日

一次修了 (推定)

2026年9月30日

研究の完了 (推定)

2026年9月30日

試験登録日

最初に提出

2026年5月11日

QC基準を満たした最初の提出物

2026年5月11日

最初の投稿 (実際)

2026年5月19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5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 26941, Study 1.3
  • 1R21MH140210-01 (米国 NIH グラント/契約)

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?

いいえ

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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