神経性過食症の食事中のニューロフィードバック
食事中のニューロフィードバック：神経性過食症の新しい機構的治療法
The purpose of this study is to examine the effects of noninvasive prefrontal cortex (PFC) neurofeedback during eating in women with bulimia nervosa (BN) using a wearable brain imaging device, functional near-infrared spectroscopy (fNIRS). The investigators will examine how this training may influence inhibitory control and BN symptoms.
調査の概要
詳細な説明
The purpose of this study is to examine the effects of PFC neurofeedback during eating in women with bulimia nervosa (BN) using fNIRS. Specifically, the study aims 1) to demonstrate ventrolateral PFC (vlPFC) neurofeedback target engagement in women with BN using fNIRS; and 2) to link changes in PFC activation to changes in inhibitory control and eating-related symptoms.
Data will be collected from women with BN who will be randomly assigned to one of two group conditions (real or sham-control neurofeedback during eating). Participation includes a phone screening assessment, psychodiagnostic assessment, one in-person evaluation, one neurofeedback session, behavioral tasks, online questionnaires before and after the neurofeedback session, and a remote follow-up assessment.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Laura A Berner, Ph.D.
- メール：laura.berner@mssm.edu
研究連絡先のバックアップ
- 名前：Sila Sozeri, B.A.
- 電話番号：(212) 201-2679
- メール：sila.sozeri@mssm.edu
研究場所
-
-
New York
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New York、New York、アメリカ、10027
- 募集
- Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai
-
主任研究者：
- Laura A. Berner
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion criteria:
- Female
- Aged 18 to 45 years
- Meet diagnostic criteria for bulimia nervosa
- Current body mass index greater than or equal to 18.5kg/m2 but under 30kg/m2
- English-speaking
Exclusion criteria:
- Ongoing medical treatment, major medical condition, or psychiatric disorder that may interfere with study variables or participation
- Current psychotherapy focused primarily on eating disorder symptoms
- Pregnancy or planned pregnancy, or lactation during the study period
- Allergy to ingredients in the standardized meal or in the shake
研究計画
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Real fNIRS Neurofeedback Arm
Participants assigned to the experimental arm will see their true, real-time brain activation (i.e., active real-time neurofeedback) during the neurofeedback session. This activation will be displayed to the participant as a thermometer that will increase as brain activation in the target region increases. |
Participants will be instructed to use real-time fNIRS neurofeedback to non-invasively regulate neural activation associated with symptoms in individuals with bulimia nervosa. During the training, participants will view images on a computer screen, listen to sounds, and consume a shake. |
|
偽コンパレータ：Sham-Control fNIRS Neurofeedback Arm
Participants assigned to the sham-control arm will see false feedback (or a fake signal) that is not connected to their right vlPFC activation during the neurofeedback session. |
Participants will be instructed to use sham real-time fNIRS neurofeedback to non-invasively regulate neural activation associated with symptoms in individuals with bulimia nervosa. During the training, participants will view images on a computer screen, listen to sounds, and consume a shake. |
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 |
|---|---|---|
|
Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity
時間枠：approximately 1 hour
|
The investigators will evaluate changes in PFC neural activation and connectivity as a function of neurofeedback. |
approximately 1 hour
|
|
Go/no-go task performance
時間枠：2 weeks
|
Participants will complete a go/no-go task 1 week before and 1 week after the neurofeedback session to measure inhibitory control. Participants behavioral performance on the go/no-go task will be determined by the percentage of incorrect responses made as they are prompted to react to different pictorial stimuli. Participants' percentages of error can range from 0% to 100%. A higher percentage indicates a lower behavioral performance on the task. |
2 weeks
|
|
Number of loss-of-control eating and purging episodes
時間枠：2 weeks
|
Frequency of loss-of-control eating and purging episodes. Participants will self-report on how often loss-of-control eating and purging episodes occur using electronic daily diaries in the week before and the week after the neurofeedback session. |
2 weeks
|
|
Severity of loss-of-control eating scale
時間枠：2 weeks
|
Severity of loss-of-control eating. Participants will rate the severity of their feelings of control over eating and purging episodes on a Likert-type scale from 0-10. Higher score indicates greater severity of loss of control. |
2 weeks
|
協力者と研究者
捜査官
- 主任研究者：Laura A Berner, Ph.D.、Icahn School of Medicine at Mount Sinai
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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?
IPD プランの説明
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD 共有時間枠
Immediately following publication and ending 5 years following article publication.
IPD 共有アクセス基準
Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to laura.berner@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years after article publication via direct request to the investigator.
IPD 共有サポート情報タイプ
- 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
米国FDA規制機器製品の研究
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