Neuromodulation Augmented Cognitive Training to Improve Cognitive Flexibility in Anorexia Nervosa
2022年2月28日 更新者：University of Minnesota
The purpose of the study is to evaluate the use of a new brain stimulation tool called transcranial direct current stimulation (tDCS).
tDCS is a new technique used to stimulate the brain.
The investigators believe that it may help to change brain function in individuals with anorexia nervosa.
The brain stimulation occurs outside the head.
The tDCS procedure involves applying a small amount of electrical current across the scalp, for a short period of time.
This small electrical current is able to change the electrical activity inside areas of the brain.
In the current study, the investigators will ask participants to complete computer-based brain training sessions.
While participants do the brain training exercises, they will receive either real tDCS for "sham" tDCS.
"Sham" tDCS means that participants might feel sensations like tingling or vibrations from the tDCS machine, but will not actually receive the electrical current.
Investigators will also ask participants to complete several tests to assess changes in brain function.
The information gained from this study will help investigators to understand how tDCS could be used to improve brain function and learning in individuals with anorexia nervosa.
調査の概要
状態
引きこもった
研究の種類
介入
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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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota
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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年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Age 18+ years
- Documented enrollment in residential-level treatment at The Emily Program and meeting criteria for AN (BMI <18.5).
- Participant must be capable of giving informed consent, based on University of California San Diego (UCSD) Brief Assessment of Capacity to Consent (UBACC)39 risk assessment, which has been uploaded to ETHOS.
- Sufficient spoken English so as to be able to comprehend testing procedures.
Exclusion Criteria:
- Substance abuse in the participant
- Neurological condition or other developmental disorder
- Serious psychiatric disorder known to affect brain functioning and cognitive performance
- Medical instability, which will be evident based on required admittance status in the residential treatment facility from which participants will be recruited. (The Emily Program residential treatment patients are followed closely by a medical provider, who routinely assesses medical stability throughout the duration of each patient's stay in the treatment facility; therefore, if a participant is not currently a patient in this setting and/or has been recently discharged from residential treatment setting due to medical need to receive higher level of care/inpatient-level care, they will be excluded from enrollment in this study).
- MRI contraindication [based on Center for Magnetic Resonance Research (CMRR) prescreening protocol]
- tDCS contraindication (e.g., history of craniotomy, history of metallic cranial plates, screws, implanted devices).
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
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：Active tDCS
Participants will receive 10 sessions of active tDCS + cognitive training.
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Transcranial direct current stimulation, involving low-levels of electrical stimulation applied to the right and left DLPFC will be used in conjunction with cognitive training for 46 minutes.
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偽コンパレータ：Sham tDCS
Participants will receive 10 sessions of sham tDCS + cognitive training.
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Sham transcranial direct current stimulation, involving no electrical stimulation will be used in conjunction with cognitive training for 46 minutes.
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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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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 and rate of treatment dropout in treatment-seeking adults with AN receiving treatment in a residential treatment program for eating disorders.
時間枠：Through study completion, an average of 1 year.
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Treatment-related adverse events will be assessed by CTCAE v4.0 criteria.
Participant dropout will be examined in effort to evaluate whether individuals with AN will tolerate the procedures and remain in the study.
This will be evinced by less than 20% dropout over the course of active tDCS and cognitive training.
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Through study completion, an average of 1 year.
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Change from Baseline to End of Treatment Set-Shifting Task Performance Following 10-session tDCS + Cognitive Training Intervention Protocol.
時間枠：Through study completion, an average of 1 year.
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Changes in cognitive flexibility will be assessed by examining differences between baseline and end of treatment performance on reversal learning task.
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Through study completion, an average of 1 year.
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Change from Baseline to End of Treatment Resting State and Task-based Functional Magnetic Resonance Imaging (fMRI) Activation during Reversal Learning Task Following 10-session tDCS + Cognitive Training Intervention Protocol.
時間枠：Through study completion, an average of 1 year.
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Changes in brain circuitry assessed during resting state and task-based fMRI will be assessed to examine whether active tDCS is associated with greater change in associated circuitry, as compared with sham tDCS.
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Through study completion, an average of 1 year.
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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 Eating Disorder Examination (EDE) Scores from Baseline to End of Treatment
時間枠：Through study completion, an average of 1 year.
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Change in eating disorder psychopathology, measured by the EDE, will be evaluated over the course of a 10-session tDCS + cognitive training intervention to determine whether tDCS is associated with significant change in eating pathology among individuals with Anorexia Nervosa.
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Through study completion, an average of 1 year.
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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：Kelvin O Lim, MD, PhD、University of Minnesota
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)
2019年8月30日
一次修了 (実際)
2021年12月31日
研究の完了 (実際)
2021年12月31日
試験登録日
最初に提出
2018年7月24日
QC基準を満たした最初の提出物
2018年8月22日
最初の投稿 (実際)
2018年8月27日
学習記録の更新
投稿された最後の更新 (実際)
2022年3月14日
QC基準を満たした最後の更新が送信されました
2022年2月28日
最終確認日
2022年2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。
アクティブtDCSの臨床試験
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Universite du Littoral Cote d'Opale募集
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University of Minnesota引きこもった
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The Hospital for Sick Children完了
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University of Electronic Science and Technology...完了
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Medical University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)引きこもった
Transcranial direct current stimulationの臨床試験
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)完了