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The Brain Alerting Mechanism Study

2016年12月16日 更新者:University of Florida

The Role of Brain Arousal Systems in Cognitive and Physical Decline in Normal Aging

This is a study designed to look at how arousal levels in the brain change with age and how these changes influence thinking, vision, hearing and physical function in people of advanced age.

調査の概要

詳細な説明

There are two parts involved in this study:

Part #1- Paperwork, Computer-based cognitive tests, Physical function test, EEG recording

  • Potential participants will be pre-screened at the time of their initial phone call to be sure they fit the guidelines for this research study.
  • Participants will be given this Informed Consent document. This Informed Consent will be reviewed in a private location; participants will be given as much time as participants need to consider enrolling in the study. Participants may want to discuss the information with friends or family. Participants may ask questions at any time during the study visit.
  • If participants choose to sign this form, and agree to participate, participants will be further screened for inclusion/exclusion factors related to the MRI scanning. All women under the age of 62 will be given a pregnancy test, based on a urine sample.
  • Investigators will review a detailed Medical History form with participants, asking questions about participants and participants family's medical history.
  • Investigators will ask participants to complete a brief physical activity questionnaire asking questions about participants daily level of physical activity.
  • Participants will be asked to complete several computer tasks meant to measure participants cognitive abilities (like memory and attention), which takes about 30 minutes.
  • Participants will also be asked to complete a short physical performance battery (SPPB), that looks at participants ability to sit and stand, walk a short distance, and balance, which takes about 30 minutes.
  • Participants will also be asked to participate in an EEG recording session. An EEG cap, selected for participants head size, will be placed on participants head. The cap contains small electrodes that record participants brains electrical activity. During this part of the study, participants will sit in a comfortable chair while watching pictures on a computer screen, listening to sounds through headphones, or resting. This will take about 1 hour.
  • Participants will also be asked to undergo a cold pressor test (CPT) and/or sham stimulation. CPT involves immersing either participants hand or foot in cold water for about one minute. Sham stimulation involved immersing either the hand or foot in room temperature water for about one minute.
  • Finally, participants will be transported by someone involved with this study (by passenger van or golf cart) to the McKnight Brain Institute MRI Center. Or, if participants prefer, the next portion of the visit can be scheduled for another day.

Part #2- MRI Scan

The following procedures will take place at the Advanced Magnetic Resonance Imaging Center at the McKnight Brain Institute- for the MRI brain scan, and can be done on the same day as Part #1, or on a different day for participants scheduling convenience.

Magnetic resonance imaging (MRI) is a procedure that allows doctors to look inside the body by using a scanner that sends out a strong magnetic field and radio waves. This procedure is used routinely for medical care and is very safe for most people, but participants will be monitored during the entire MRI scan in case any problems occur. The risks of MRI are:

  • The MRI scanner contains a very strong magnet. Therefore, participants may not be able to have the MRI if participants have any type of metal implanted in participants body, for example, any pacing device (such as a heart pacer), any metal in participants eyes, or certain types of heart valves or brain aneurysm clips. Someone will ask participants questions about this before participants have the MRI.
  • There is not much room inside the MRI scanner. Participants may be uncomfortable if participants do not like to be in close spaces ("claustrophobia"). During the procedure, participants will be able to talk with the MRI staff through a speaker system, and, in the event of an emergency, participants can tell them to stop the scan.
  • The MRI scanner produces a loud hammering noise, which has produced hearing loss in a very small number of patients. Participants will be given earplugs to reduce this risk.

研究の種類

観察的

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

    • Florida
      • Gainesville、Florida、アメリカ、32610
        • University of Florida

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~95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

サンプリング方法

非確率サンプル

調査対象母集団

Healthy adults 18 and older.

説明

Inclusion Criteria:

  • Ages 18 to 95

Exclusion Criteria:

  • History of pre-existing neurological disorders,
  • Psychiatric brain disorders,
  • Diagnosis with a neurodegenerative brain disease,
  • Uncontrolled blood pressure (>200/110),
  • History of severe hypertension,
  • History of angina
  • People who have metal implants and can not have an MRI scan,
  • People who are claustrophobic,
  • Females of child-bearing age and have a positive test for pregnancy

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

コホートと介入

グループ/コホート
介入・治療
Cold pressor stimulation
Immersion of the foot in 0-2 degrees C water for 50 seconds.
Immersion of the foot in 0-2 degrees C water for 50 seconds
Sham Stimulation
Immersion of the foot in room temperature water for 50 seconds.
Immersion of the foot in room temperature water for 50 seconds

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
Cognitive Function
時間枠:Baseline

The Cognition Domain measures several aspects of cognitive functioning for ages 3-85, including language, episodic memory, executive function, working memory and processing speed.

To interpret individual performance, one can evaluate all three types of scale scores. A participant's age-adjusted scale score at or near 100 indicates vocabulary ability that is average for the age level. Scores around 115 suggest above-average vocabulary ability, while scores around 130 suggest superior ability.

Baseline
MRI: BOLD Response
時間枠:Baseline
Functional MRI
Baseline
Cognitive Function
時間枠:up to 30 days

The Cognition Domain measures several aspects of cognitive functioning for ages 3-85, including language, episodic memory, executive function, working memory and processing speed.

To interpret individual performance, one can evaluate all three types of scale scores. A participant's age-adjusted scale score at or near 100 indicates vocabulary ability that is average for the age level. Scores around 115 suggest above-average vocabulary ability, while scores around 130 suggest superior ability.

up to 30 days
MRI: BOLD Response
時間枠:up to 30 days
Functional MRI
up to 30 days

二次結果の測定

結果測定
メジャーの説明
時間枠
Physiological Response: Mean Heart Rate
時間枠:Baseline
Heart Rate
Baseline
Cognitive Functions: N-Back Task Test
時間枠:Baseline
N-Back Score is as follows: the mean is 100 and the standard deviation (SD) is 15.
Baseline
Cognitive Functions: Attention Tasks Test
時間枠:Baseline
Attention tests score is measured using a of mean 100 and the standard deviation (SD) is 15.
Baseline
Cognitive Functions: Memory Task Test
時間枠:Baseline
The memory tests scoring for ease of understanding, corresponds to an Age-Adjusted Scale Score of 115 - exactly 1 SD above the mean of 100.
Baseline
Physical Function: Short Physical Performance Battery
時間枠:Baseline
Short battery of tests that include walking and standing. The score includes the distance to range from 400m to 700m. A lower score indicates worse function.
Baseline

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:Adam J Woods, PhD、University of Florida

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

2013年11月1日

一次修了 (実際)

2015年6月1日

研究の完了 (実際)

2015年6月1日

試験登録日

最初に提出

2014年1月23日

QC基準を満たした最初の提出物

2014年1月28日

最初の投稿 (見積もり)

2014年1月30日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年12月19日

QC基準を満たした最後の更新が送信されました

2016年12月16日

最終確認日

2016年12月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • IRB201300392

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。

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