Effects of Transcutaneous Vagus Nerve Stimulation on Pain and Brain Activity in Healthy Adults
2026年9月14日 更新者：David A. Purger
The Effects of Transcutaneous Vagus Nerve Stimulation (tVNS) on Acute Pain Perception and Brain Activity in Healthy Adults
The goal of this clinical trial is to learn whether stimulating a nerve in the neck changes how much pain people feel. It also looks at whether this stimulation changes brain activity. The study is being done in healthy adults ages 18 to 70.
The nerve being studied is called the vagus nerve. It runs through the neck and connects to parts of the brain that handle pain. In this study, the nerve is stimulated from outside the body using a small device placed on the skin. There is no surgery, and nothing is implanted.
The main questions it aims to answer are: (1) Does stimulating the vagus nerve lower the pain people feel during a cold water test? (2) Does stimulating the vagus nerve change the electrical activity in the brain?
Researchers will compare pain ratings and brain activity under three conditions in the same person: no stimulation, real stimulation over the vagus nerve, and sham stimulation placed nearby on the neck. Sham stimulation feels similar but is not aimed at the nerve.
Participants will: (1) Come to one visit that lasts about 90 minutes, with no follow-up visits, (2) Wear a cap that records the brain's natural electrical signals for the whole visit, (3) Place both hands in cold water, about 39 degrees Fahrenheit, up to three times for up to 2 minutes each time, (4) Rate their pain after each cold water test, (5) Wear a stimulation device on the neck during two of the three cold water tests, (6) Not be told which of those two is the real stimulation until the visit is over.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
20
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：Caliel Hines
- 電話番号：317-963-7010
- メール：calhines@iu.edu
研究連絡先のバックアップ
- 名前：Marissa Lowe
- メール：lowemj@iu.edu
研究場所
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Indiana
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Indianapolis、Indiana、アメリカ、46202
- IU Health Neuroscience Center
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コンタクト：
- Department of Neurological Surgery
- 電話番号：317-963-1300
- メール：dpurger@iu.edu
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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:
- Adults aged 18 to 70 years
- Healthy, defined as having no history of chronic medical, neurological, or psychiatric conditions
- Not currently experiencing acute illness or chronic pain
- Not currently taking medications that influence the nervous system or pain sensitivity
- Willing and able to provide written informed consent in English
Exclusion Criteria:
- History of vagal or vasovagal symptoms
- Respiratory distress
- Cardiac arrhythmia
- Sleep apnea
- Pregnancy
- Substance abuse
- Primary psychiatric disorder
- Prior vagus nerve stimulation or any implanted medical device
- Significant acute or chronic neurologic illness that, in the judgment of the Principal Investigator, could compromise participant safety, limit the ability to complete the study, or compromise the objectives of the study
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 |
|---|---|
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実験的：Active Stimulation First, Then Sham
Participants complete a cold pressor test with no stimulation, then a second cold pressor test during active transcutaneous vagus nerve stimulation, then a third during sham stimulation.
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Stimulation applied over the cervical branch of the vagus nerve, anterior to the sternocleidomastoid along the carotid sheath.
Pulse width 200 microseconds, frequency 30 Hz, rectangular monophasic waveform, intensity titrated between 17.8 and 39.5 volts to a mild tingling sensation below the threshold of discomfort.
Stimulation is maintained for 20 minutes before the cold pressor test and continues throughout it.
Identical device, parameters, and duration as the active condition, differing only in placement.
The device is positioned slightly posterior on the neck, away from the cervical branch of the vagus nerve.
Immersion of both hands up to the wrist in water maintained at 4 degrees Celsius with ice for up to two minutes or as long as tolerated.
Performed three times per participant: once with no stimulation, once during active stimulation, and once during sham stimulation.
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実験的：Sham Stimulation First, Then Active
Participants complete a cold pressor test with no stimulation, then a second cold pressor test during sham stimulation, then a third during active transcutaneous vagus nerve stimulation.
|
Stimulation applied over the cervical branch of the vagus nerve, anterior to the sternocleidomastoid along the carotid sheath.
Pulse width 200 microseconds, frequency 30 Hz, rectangular monophasic waveform, intensity titrated between 17.8 and 39.5 volts to a mild tingling sensation below the threshold of discomfort.
Stimulation is maintained for 20 minutes before the cold pressor test and continues throughout it.
Identical device, parameters, and duration as the active condition, differing only in placement.
The device is positioned slightly posterior on the neck, away from the cervical branch of the vagus nerve.
Immersion of both hands up to the wrist in water maintained at 4 degrees Celsius with ice for up to two minutes or as long as tolerated.
Performed three times per participant: once with no stimulation, once during active stimulation, and once during sham stimulation.
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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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Pain intensity measured by the Numerical Pain Rating Scale
時間枠：Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
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Participant-reported pain intensity on an 11-point scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Higher scores indicate greater pain.
Rated immediately after each cold pressor test.
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Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
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Pain intensity measured by the Visual Analogue Scale
時間枠：Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
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Participant-reported pain intensity is marked on a 100 mm line anchored at 0 mm for no pain and 100 mm for the worst imaginable pain.
The distance in millimeters from the left anchor is recorded as the score.
Higher scores indicate greater pain.
Rated immediately after each cold pressor test.
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Immediately after each of the three cold pressor tests during a single visit, approximately 90 minutes.
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Pain threshold during cold pressor test
時間枠：During each of the three cold pressor tests within a single visit, approximately 90 minutes.
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Time in seconds from hand immersion to the participant's first verbalized sensation of pain, recorded separately for each hand.
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During each of the three cold pressor tests within a single visit, approximately 90 minutes.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in EEG spectral power
時間枠：Continuously throughout a single visit, approximately 90 minutes.
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Change in spectral power within canonical frequency bands (delta 1 to 4 Hz, theta 4 to 8 Hz, alpha 8 to 12 Hz, beta 13 to 30 Hz, gamma above 30 Hz), measured by continuous 16-channel electroencephalography, compared across resting baseline, stimulation without noxious stimulus, and stimulation during cold pressor test.
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Continuously throughout a single visit, approximately 90 minutes.
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Change in EEG functional connectivity
時間枠：Continuously throughout a single visit, approximately 90 minutes.
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Change in functional connectivity between brain regions, derived from continuous 16-channel electroencephalography.
Phase locking values are computed for each pair of EEG channels within canonical frequency bands, and connectivity metrics are derived from those values.
Coherence is assessed in the frequency domain.
Analyses are restricted to predefined, theory-driven regions and frequency bands.
Compared across resting baseline, stimulation without noxious stimulus, and stimulation during the cold pressor test.
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Continuously throughout a single visit, approximately 90 minutes.
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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。
スポンサー
捜査官
- 主任研究者：David A Purger, MD, PhD、Indiana University
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1月1日
研究の完了 (推定)
2028年1月1日
試験登録日
最初に提出
2026年9月14日
QC基準を満たした最初の提出物
2026年9月14日
最初の投稿 (実際)
2026年9月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月18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14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
- 27960
- SNEU-IIR-TVNS-ADULTS (その他の識別子：Indiana University IRB)
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
IPD プランの説明
This is a small exploratory pilot study in healthy volunteers, designed to generate preliminary effect size estimates rather than definitive findings.
With a target enrollment of 20 participants at a single site, the dataset is small enough that a decision about sharing individual participant data has been deferred.
The current informed consent form does not specifically address sharing de-identified individual participant data with researchers outside the study team.
Any future data sharing would require review of participant consent and approval by the Indiana University Institutional Review Board.
The study team will revisit this decision before study completion.
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。