Cognitive and Electrophysiological Assessment of Non-Invasive Temporally-Interfering Electric Fields Stimulation (TIEFS) (TIEFS)
2026年6月16日 更新者：University of California, Davis
The goal of this clinical trial is to learn how a non-invasive brain stimulation method called Temporally Interfering Electric Fields Stimulation (TIEFS) affects brain activity and thinking in adults. TIEFS uses electrical currents applied to the scalp to influence brain activity without surgery.
The main questions this study aims to answer are:
- How does TIEFS change brain signals measured with brain recordings?
- Does TIEFS affect thinking abilities such as memory, language, movement, or perception?
- Is TIEFS safe and well tolerated when used in people?
This study includes two groups of participants. One group includes adults with epilepsy who are already undergoing specialized brain monitoring as part of their medical care. The other group includes healthy adults with no history of seizures.
Participants will:
- Receive brief sessions of TIEFS using electrodes placed on the scalp
- Complete computer-based tasks that test memory, attention, language, or movement. Answer questions about how the stimulation feels
- Have brain activity recorded during the study
Each study visit lasts up to three hours and may occur in one or two sessions. Information from this study may help researchers better understand the human brain and support the development of future non-invasive brain stimulation treatments.
調査の概要
研究の種類
介入
入学 (推定)
15
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：Nigel P Pedersen, MBBS
- 電話番号：617-462-8120
- メール：nppedersen@health.ucdavis.edu
研究連絡先のバックアップ
- 名前：Raul S Castillo-Astorga, MD
- 電話番号：530-220-0057
- メール：rcastilloastorga@ucdavis.edu
研究場所
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California
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Sacramento、California、アメリカ、95817
- 募集
- University of California Davis Medical Center
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コンタクト：
- Nigel P Pedersen, MBBS
- 電話番号：617-462-8120
- メール：nppedersen@health.ucdavis.edu
-
主任研究者：
- Nigel P Pedersen, MBBS
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-
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
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Adult patients (age 18-65 years of age) undergoing an intracerebral electrophysiology study for epilepsy pre-surgical evaluation are eligible for inclusion.
- For healthy control subjects are also eligible for inclusion (Scalp EEG measurements).
- Participants must be able to sufficiently speak and understand English or Spanish for consent and be able to understand and complete cognitive tasks.
- All subjects must have the ability to give valid informed consent.
Exclusion Criteria:
- No pregnant women will be recruited.
- People with implanted electrical devices such as Deep Brain Stimulation devices or Pacemakers.
- No prisoners will be recruited.
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：非ランダム化
- 介入モデル：順次割り当て
- 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 |
|---|---|
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実験的：Comparison of Active vs Sham TIEFS Stimulation in SEEG patients
This arm involves a within-subject comparison of different frequencies of active TIEFS stimulation and sham stimulation, all within the same session.
Patients will already have been admitted to SEEG surgery, and will be approached while still having the electrodes implanted.
Each participant will receive multiple types of stimulation at different envelope frequencies (ranging from 1-130 Hz).
During the session, electrodes will be placed on the scalp to administer TIEFS at varying frequencies.
Each frequency will be tested in separate trials within the session, with multiple trials per frequency.
The results from these trials will be averaged to determine the overall impact of each frequency on brain activity (measured through SEEG) and/or cognitive functions (evaluated using tasks related to memory, language, motor function, and perception).
Sham stimulation will also be delivered within the same session, and participants will be blinded to the type of stimulation (active vs sham).
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Temporal Interference Electrical Stimulation (TIEFS) is a non-invasive brain stimulation technique that uses two high-frequency electrical fields (>1 kHz) to generate an interference pattern at a specific brain region, creating a low-frequency envelope (Δf = f2 - f1) at the target depth.
Unlike traditional stimulation methods, which affect only superficial brain regions, TIEFS can reach deeper structures without the need for implanted electrodes.
The stimulation is applied through scalp electrodes.
It has the potential for targeted brain interventions in both functional studies and clinical applications for neurological conditions.
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実験的：Comparison of Active vs Sham TIEFS Stimulation in Healthy Subjects
This arm involves a within-subject comparison of active and sham TIEFS stimulation in healthy control subjects.
Participants will receive both active and sham stimulation in a single session, with different frequencies of TIEFS applied during active stimulation.
The goal is to measure the changes in brain activity using EEG and assess the impact of TIEFS on cognitive functions such as memory, motor function, language, and perception.
Participants will be blinded to the type of stimulation they are receiving during the session.
|
Temporal Interference Electrical Stimulation (TIEFS) is a non-invasive brain stimulation technique that uses two high-frequency electrical fields (>1 kHz) to generate an interference pattern at a specific brain region, creating a low-frequency envelope (Δf = f2 - f1) at the target depth.
Unlike traditional stimulation methods, which affect only superficial brain regions, TIEFS can reach deeper structures without the need for implanted electrodes.
The stimulation is applied through scalp electrodes.
It has the potential for targeted brain interventions in both functional studies and clinical applications for neurological conditions.
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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 |
|---|---|---|
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Brain activity changes during Stimulation
時間枠：Measurements will be recorded throughout the stimulation session (lasting up to 90 minutes), with data collected before, during, and immediately after each stimulation.
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This outcome measures the changes in brain activity, either measured through scalp EEG electrodes (in Healthy Participant controls), or intracranial stereotaxic EEG electrodes (for SEEG pre-surgical evaluation epilepsy patients).
Local field potential (LFP) power and EEG power in response to active TIEFS stimulation will be compared to sham stimulation.
Electrical signals recorded from the brain reflect neural activity.
Intracranial signals will be measured across different locations in the brain using implanted SEEG electrodes.
Additionally, SEEG electrodes may have tetrodes tips to capture single neuron activity.
We will compare how the brain's electrical activity changes during active TIEFS at various frequencies and during the sham stimulation to assess the impact on brain and neural function.
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Measurements will be recorded throughout the stimulation session (lasting up to 90 minutes), with data collected before, during, and immediately after each stimulation.
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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。
捜査官
- 主任研究者：Nigel P Pedersen, MBBS、University of California Davis, School of Medicine, Neurology Department
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)
2025年4月16日
一次修了 (推定)
2027年4月15日
研究の完了 (推定)
2027年4月15日
試験登録日
最初に提出
2026年6月16日
QC基準を満たした最初の提出物
2026年6月16日
最初の投稿 (実際)
2026年6月23日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月23日
QC基準を満たした最後の更新が送信されました
2026年6月16日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
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
Upon publication, anonymized individual participant data (IPD) will be shared as part of the supplementary materials.
The shared data will include EEG recordings, cognitive task results (memory, language, motor, perception), and stimulation parameters (active vs sham, frequencies).
All IPD will be de-identified, with personal identifiers removed to ensure confidentiality and compliance with HIPAA.
The de-identified data will be made available through a repository or data-sharing platform, accessible to qualified researchers for scientific and educational use only.
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。