Real-Time fMRI Feedback Effects on Pain Perception
2019年3月18日 更新者：Medical University of South Carolina
The purpose of this study is to determine whether real-time functional magnetic resonance imaging may be a viable treatment for chronic pain in the future.
調査の概要
状態
完了
詳細な説明
Twenty-four healthy volunteers will undergo a series of four fMRI scanning sessions wherein thermal pain stimuli will be used to elicit activation of the pain neuro-matrix.
All participants will undergo thermal pain threshold testing before and after fMRI scan.
Participants will also rate the painfulness and unpleasantness of the thermal stimuli applied before fMRI and after fMRI.
All participants will be given prompts to apply a set of cognitive pain-control strategies.
Half of the participants will receive real-time fMRI feedback of activity in the Right Anterior Cingulate Cortex (rACC) and the other half will receive real-time fMRI feedback of activity in the Prefrontal Cortex (PFC).
It is hypothesized that those receiving real-time feedback of brain activity thought to be involved with analgesic effects will demonstrate greater analgesia associated with the application of the cognitive control techniques after fMRI paradigm (decreased pain intensity and unpleasantness ratings and increased thermal pain thresholds) than those who are not given feedback before fMRI paradigm.
研究の種類
介入
入学 (実際)
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。
研究場所
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South Carolina
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Charleston、South Carolina、アメリカ、29425
- Medical University of South Carolina
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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
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Healthy adults ages 18-65
Exclusion Criteria:
- Clinical depression
- Anxiety
- Substance dependence or chronic pain
- Ferrous metal implants
- Cardiac pacemakers or other implanted medical devices that might be adversely impacted by the MRI scanner magnetic field
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
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：ACC Real Time fMRI Feedback
Each participant will undergo thermal pain threshold assessments ten times using the Medoc Pathway System with MRI-compatible ATS Thermode (30mmX30mm; Medoc Inc, Israel). Participants will be instructed to "focus on the thermal stimuli" for the first 5 trials, and to engage in three cognitive pain inhibition strategies (Attention/Distraction Strategy, Stimulus Quality/Severity Strategy, and the Control Strategy. The participants will be randomly assigned to receive Real Time fMRI Feedback of inverse activation in the rACC after each pain/rest block during the last 3 fMRI scans in the form of two simple thermometer images on the in-scanner computer display. |
One of three Cognitive Pain Inhibition Strategies.
The Participant will be instructed to attend away from the thermal stimulus (for example, to the other side of the body).
Vividly imagine they are somewhere else, or engage in a high-demanding mental task such as counting backward by 7's or completing math problems to distract from the experience
One of three Cognitive Pain Inhibition Strategies.
The Participant will be instructed to attempt to perceive the stimulus as a neutral sensory experience rather than pain.
Attempt to perceive the stimulus as low intensity rather than high intensity.
One of three Cognitive Pain Inhibition Strategies.
The Participant will be instructed to attempt to take control of their perception of the painful experience.
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実験的：PFC Real Time fMRI Feedback
Each participant will undergo thermal pain threshold assessments ten times using the Medoc Pathway System with MRI-compatible ATS Thermode (30mmX30mm; Medoc Inc, Israel).
Participants will be instructed to "focus on the thermal stimuli" for the first 5 trials, and to engage in three cognitive pain inhibition strategies (Attention/Distraction Strategy, Stimulus Quality/Severity Strategy, and the Control Strategy.
The participants will be randomly assigned to receive Real Time fMRI Feedback of inverse activation in the PFC after each pain/rest block during the last 3 fMRI scans in the form of two simple thermometer images on the in-scanner computer display.
|
One of three Cognitive Pain Inhibition Strategies.
The Participant will be instructed to attend away from the thermal stimulus (for example, to the other side of the body).
Vividly imagine they are somewhere else, or engage in a high-demanding mental task such as counting backward by 7's or completing math problems to distract from the experience
One of three Cognitive Pain Inhibition Strategies.
The Participant will be instructed to attempt to perceive the stimulus as a neutral sensory experience rather than pain.
Attempt to perceive the stimulus as low intensity rather than high intensity.
One of three Cognitive Pain Inhibition Strategies.
The Participant will be instructed to attempt to take control of their perception of the painful experience.
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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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Average Unpleasantness
時間枠：Before and After fMRI Paradigm, an average of 2 hours
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All participants will undergo thermal pain threshold testing directly before (Baseline) and after MRI. Participants will be asked to rate pain unpleasantness, on a scale of 0-10, before the fMRI Paradigm (Baseline) and directly after the fMRI paradigm (after MRI). 0="no unpleasantness" and 10="worst unpleasantness imaginable" |
Before and After fMRI Paradigm, an average of 2 hours
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Average Pain Rating
時間枠：Before and After fMRI Paradigm, an average of 2 hours
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All participants will undergo thermal pain threshold testing directly before (Baseline) and after MRI scan.Participants will be asked to rate painfulness of the thermal stimuli applied, on a scale of 0-10, before the fMRI Paradigm (Baseline) and directly after the fMRI paradigm (after MRI).
0="no pain" and 10="worst pain imaginable"
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Before and After fMRI Paradigm, an average of 2 hours
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Ability to Distract
時間枠：Before and After fMRI Paradigm, an average of 2 hours
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All participants will undergo thermal pain threshold testing before and after fMRI paradigm.
Participants will rate the ability to distract themselves from the thermal stimuli, on a scale of 0-10, before fMRI paradigm (Baseline) and after fMRI paradigm, 0="not able to distract at all" and 10="completely able to distract".
A Higher rating represents greater ability to distract from thermal pain stimuli.
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Before and After fMRI Paradigm, an average of 2 hours
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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：Jeffery J Borckardt, PhD、Medical University of South Carolina
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)
2010年11月1日
一次修了 (実際)
2016年12月1日
研究の完了 (実際)
2016年12月1日
試験登録日
最初に提出
2012年2月10日
QC基準を満たした最初の提出物
2012年4月26日
最初の投稿 (見積もり)
2012年4月30日
学習記録の更新
投稿された最後の更新 (実際)
2019年6月14日
QC基準を満たした最後の更新が送信されました
2019年3月18日
最終確認日
2019年3月1日
詳しくは
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。
Cognitive Pain Controlの臨床試験
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Dexa Medica Group完了
Attention/Distraction Strategyの臨床試験
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Arizona State UniversityFoundation for Professional Development募集
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University of British ColumbiaUniversity of Victoria; Social Sciences and Humanities Research Council of Canada完了
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Queens College, The City University of New York完了
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Rush University Medical CenterNational Center for Complementary and Integrative Health (NCCIH)完了
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Damascus University完了