Functional Connectivity Parkinson Disease
2019年10月31日 更新者：University of Colorado, Denver
Functional Connectivity of the Motor Network in Two Major Subtypes of Parkinson Disease
In this study the investigators are looking at two subtypes of Parkinson Disease (PD); "tremor-dominant" (TD) and postural imbalance and gait disorder (PIGD). This study will use magnet resonance imaging (MRI) to see how the brain reacts while resting and doing a finger-tapping task while on and off PD medication. This study will look at the differences between the two sub-types of PD and healthy volunteers.
The investigators will test the hypothesis that connectivity at rest within the motor cortex and between the motor cortex and motor-associated regions such as the supplementary motor area and the pre motor cortex will not be as strong in PIGD compared to TD (increased activity and functional connectivity in TD group)
調査の概要
状態
完了
条件
研究の種類
観察的
入学 (実際)
86
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
-
-
Colorado
-
Aurora、Colorado、アメリカ、80045
- University of Colorado Denver
-
-
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
50年～80年 (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
サンプリング方法
非確率サンプル
調査対象母集団
Patients with PD according to UK Brain Bank Criteria will be recruited from the UCD Neurology clinic.
Controls will be recruited from spouses and from the community
説明
Inclusion Criteria:
- English as their primary language
- Patients with Parkinson disease and healthy controls will be enrolled
- Parkinson patients must be on a dopaminergic medication (levodopa or dopamine agonist) and on a stable dose over the prior month
Exclusion Criteria:
- If unable to provide informed consent
- Pregnancy
- Excess of 300lbs
- Claustrophobia
- Metal in body
- Untreated neurological or psychiatric condition, who are delusional or have hallucinations, with cognitive impairment (MOCA<26), with a history of head injury sufficient to cause a concussion, or with significant systemic medical diseases (e.g. heart failure, liver failure, kidney failure, poorly controlled diabetes, etc.)
- Healthy control subjects will be excluded if taking any type of dopaminergic or anti-dopaminergic medication
- Subjects who are unable to demonstrate understanding of the study procedures and risks will be excluded
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
- 観測モデル：ケースコントロール
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
|---|
|
Tremor Dominant PD
Volunteers with predominantly tremor-related motor symptoms of PD
|
|
Postural Instability & Gait Difficulty PD
Volunteers with primarily walking & balance-related motor symptoms of PD.
|
|
Healthy Controls
Healthy volunteers consisting of people of same age as PD volunteers, w/o a diagnosis of PD.
|
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 |
|---|---|---|
|
Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.
時間枠：At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.
|
A measure of the correlation coefficients between nodes of the motor network at rest and during a tapping motor task between the "OFF" and "ON" dopaminergic medication states in the two motor subtype PD patients.
|
At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.
|
|
Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.
時間枠：At time of 2nd MRI scan: 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
|
A measure of the correlation coefficients between nodes of the motor network at rest and during a tapping motor task between the "OFF" and "ON" dopaminergic medication states in the two motor subtype PD patients.
|
At time of 2nd MRI scan: 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
|
|
Second level contrast between Parkinson Disease (PD) and Healthy Controls (HC).
時間枠：At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.
|
Differences in connectivity as measured by correlation coefficients between nodes of the motor network at rest and during a tapping motor task in PD patients of two motor subtypes and matched healthy controls.
|
At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Task-related whole-brain activations.
時間枠：At time of MRI scan, 12 or more hours after their last dose of dopaminergic medication.
|
Secondary outcome measures include task-related whole-brain activations as assessed by changes in blood oxygen-dependent (BOLD) contrast during functional magnetic resonance imaging (fMRI) scanning.
|
At time of MRI scan, 12 or more hours after their last dose of dopaminergic medication.
|
|
Task-related whole-brain activations.
時間枠：At time of 2nd MRI scan, 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
|
Secondary outcome measures include task-related whole-brain activations as assessed by changes in blood oxygen-dependent (BOLD) contrast during functional magnetic resonance imaging (fMRI) scanning.
|
At time of 2nd MRI scan, 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
|
|
Connectivity between other motor and non-motor brain regions during the tasks.
時間枠：At time of MRI scan,12 or more hours after their last dose of dopaminergic medication.
|
Secondary outcome measures include measuring the connectivity between other motor and non-motor brain regions during the tasks.
|
At time of MRI scan,12 or more hours after their last dose of dopaminergic medication.
|
|
Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments
時間枠：At time of MRI scan. 12 or more hours after their last dose of dopaminergic medication.
|
Secondary outcome measures include a measure of the correlations of brain activity and functional connectivity to structural connectivity measures as well as behavioral and clinical assessments.
|
At time of MRI scan. 12 or more hours after their last dose of dopaminergic medication.
|
|
Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments
時間枠：At time of 2nd MRI scan. 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
|
Secondary outcome measures include a measure of the correlations of brain activity and functional connectivity to structural connectivity measures as well as behavioral and clinical assessments.
|
At time of 2nd MRI scan. 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
|
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：Brian Berman, MD, MS、University of Colorado, Denver
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
2011年6月1日
一次修了 (実際)
2017年10月1日
研究の完了 (実際)
2017年10月1日
試験登録日
最初に提出
2012年12月11日
QC基準を満たした最初の提出物
2013年2月21日
最初の投稿 (見積もり)
2013年2月26日
学習記録の更新
投稿された最後の更新 (実際)
2019年11月1日
QC基準を満たした最後の更新が送信されました
2019年10月31日
最終確認日
2019年10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。
パーキンソン病の臨床試験
-
Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ