このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Behavior in Children With Attention Deficit Hyperactivity Disorder and in Healthy Volunteers

2019年12月11日 更新者:National Institute of Mental Health (NIMH)

A Behavioral and Functional Neuroimaging Study of Inhibitory Motor Control

The purpose of this study is to determine how the brain controls motor activity in children with attention deficit hyperactivity disorder (ADHD).

The inability to control one s behavior is an important symptom of many psychiatric illnesses. The stop signal paradigm which involves withholding a motor response to a go signal, has proved useful in assessing uncontrolled behavior in children with ADHD and other disorders. This study will use a stop signal paradigm in order to evaluate the ability of children with and without ADHD to control their motor behavior. A magnetic resonance imaging (MRI) scan will be used to study how the brain works during specific activities.

This study will evaluate the stop signal paradigm in three groups of people: healthy children, children with ADHD, and healthy adults. This study comprises two sub-studies: a behavioral study in which participants perform simple activities and an MRI study.

Participants will be asked to stop any over-the-counter medication 5 days before entering the behavioral or MRI study. Children with ADHD will be asked to stop taking medication for ADHD 72 hours before the study. All participants will have a medical history and a psychiatric evaluation (for children, both parents and children provide information for the assessment). Participants in the MRI study will also have physical examinations and blood and urine tests. All children will undergo intelligence tests; and those with ADHD will have tests to confirm the diagnosis. The parents of child participants will complete an autism screening questionnaire.

調査の概要

状態

完了

詳細な説明

The inability to exert appropriate inhibitory control over one's behavior is an important symptom of many psychiatric illnesses. The stop signal paradigm, which involves withholding a prepotent motor response to a signal, has proved useful in assessing this deficit in children with a range of disorders, particularly attention deficit hyperactivity disorder (ADHD). In order to adapt the paradigm for use in fMRI studies, it is important to address two methodological issues: 1) the substitution of a visual stop signal for the more commonly-employed auditory stop signal, and 2) the fact that, on the traditional stop task (in which the subject withholds a motor response to the stop signal), correct trials do not involve a motor response whereas incorrect trials do. The latter problem can be addressed using the stop-change task (in which the subject executes alternative motor responses to the stop and go signals). The first aim of this protocol is to compare behavioral data from the stop and stop-change tasks in control adults, control children, and children with ADHD. These data will be used to test the hypotheses that, on each of these paradigms, children with ADHD will show an inhibitory deficit compared to control children, and control children will show an inhibitory deficit compared to control adults. The second aim of the protocol is to conduct a pilot fMRI study of the stop and stop-change tasks in control adults. The study has an event-related design and will test the hypotheses that ventral prefrontal activation will be greater during successful than unsuccessful stop (or stop-change) trials, and that stop and stop-change trials will be associated with more anterior cingulate and right inferior frontal activation than will go trials.

研究の種類

観察的

入学 (実際)

189

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

    • Maryland
      • Bethesda、Maryland、アメリカ、20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

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

8年~17年 (子)

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:

CONTROL SUBJECTS:

Male and female subjects in two age cohorts will be recruited: 7-16 and 18-45 years. Subjects must be free from any current or past psychopathology and be medication-free. The 7-16 year olds will be gender matched to the ADHD subjects.

ADHD SUBJECTS:

Male and female subjects aged 7-16 who currently meet DSM-IV criteria for ADHD. The diagnosis will be made on the basis of a K-SADS-PL interview with the parent and a t score greater than 65 on the hyperactivity-impulsivity subscale of the Connors Teacher Scale. With the exception of symptoms and signs attributable to the ADHD, Oppositional Defiant Disorder, the Learning, Communication Disorders, Elimination Disorders, and Separation or Social Anxiety Disorders, subjects must be free from any current or past psychopathology.

fMRI STUDY:

Subjects aged 8-45 years will be recruited. Otherwise the same as for the behavioral study above for healthy volunteers and ADHD participants.

EXCLUSION CRITERIA:

CONTROL SUBJECTS:

I.Q. less than 80; pregnancy ; ongoing medical illness; neurological disorder (including seizures); meeting past or present criteria for any diagnosis on the K-SADS-PL (children and adolescents) or SCID (adults).

ADHD SUBJECTS:

I.Q. less than 80; pregnancy; ongoing medical illness or neurological disorder other than ADHD; contraindication to discontinuing medication for 72 hours; any other psychiatric disorder that is sufficiently severe to require specific treatment, with the exception of Oppositional Defiant Disorder, and the Learning, Communication, and Elimination Disorders, Separation Anxiety Disorder or Social Anxiety Disorder. Explicit exclusions include Pervasive Developmental Disorders, Tourette's syndrome, conduct disorder, and mood or Generalized anxiety disorders.

fMRI STUDY:

I.Q. less than 80; pregnancy; ongoing medical illness; neurological disorder (including seizures); meeting past or present criteria for any diagnosis on SCID; or KSADS except for ADHD, Oppositional Defiant Disorder, the Learning, Communication Disorders, Elimination Disorders, and Separation or Social Anxiety Disorders; any metallic objects in the body that would constitute a contraindication to an fMRI scan.

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

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。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

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

2001年11月7日

研究の完了

2018年10月9日

試験登録日

最初に提出

2001年11月9日

QC基準を満たした最初の提出物

2001年11月9日

最初の投稿 (見積もり)

2001年11月12日

学習記録の更新

投稿された最後の更新 (実際)

2019年12月12日

QC基準を満たした最後の更新が送信されました

2019年12月11日

最終確認日

2018年10月9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。

3
購読する