Physiological and Psychosomatic Effects of Exposure to MRI Scanning Environment
Background:
- Magnetic resonance imaging (MRI) creates high-quality images of the human body without x-rays. It uses a strong magnetic field and radio waves to take pictures. Researchers want to test a scanner that uses a high magnetic field strength.
Objective:
- To study how the body responds to being in a high field 11.7T MRI scanner.
Eligibility:
- Healthy people ages 22 65.
Design:
- Participants will be screened with a medical history and physical exam. They will complete a healthy volunteer questionnaire and an MRI safety screening form. They may have a 3T MRI scan of the brain.
- Participants will have an MRI scan. They will lie on a table that will slide in and out of the MRI cylinder very slowly. They will be asked to lie still.
- Participants will do simple tasks while inside the machine. These can include listening and responding to questions, tapping fingers, or moving a hand.
- While in the scanner, participants will hear loud knocking noises. They will get earmuffs.
- Right when they exit the scanner, participants will get a questionnaire to fill out. This will ask about how they felt inside the scanner.
- During the MRI, participants heart rate, respiratory rate, and skin temperature will be measured. Before and after the scan, these things plus blood pressure will be measured.
- Participants will be tested before and after being in the MRI scanner. They will answer questions, take pen-and-paper or computer tests, and do simple actions. Their sense of smell may be tested.
調査の概要
状態
条件
詳細な説明
Objective
The goals of this pilot study are to establish a normative database of vital signs, cognitive function and unusual subjective sensations in a 0T scanner. This data will be used as a reference for a future study of the effects of exposure to a 11.7T static magnetic field.
Study Population
26 healthy volunteers, aged 22-65.
Accrual ceiling =50
Accrual Target =26
Drop outs will be replaced
Design
The study consists of one outpatient screening session and one experimental session. Informed consent and a history and neurological examination will be carried out at the screening visit. Vital signs (pulse oximeter, heart rate, respiratory rate and skin temperature) will be measured immediately before and after the experimental scan session, and pulse oximeter, heart rate and respiration will be monitored when the subject is in the scanner. Subjects will remain in the scanner for approximately 1 hour. During the experimental session, while the subject is in the scanner, they will be asked to carry out a brief test of attention at 10-15 minute intervals, up to 3 times during the session. At the end of the experimental session, subjects will fill out the MRI exit questionnaire to rate subjective sensations such as nausea, vertigo, and lightheadedness, on a Likert scale and complete a computerized neuro-cognitive test battery.
Outcome Measures
The objective of the study is to obtain a normative dataset of neuropsychological test measures, physiological parameters, and subjective experiences measures in subjects undergoing 0T exposure.
研究の種類
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:
- 22 - 65 years of age
- In good general health
- Able to understand the procedures and requirements and give informed consent
- Fluent in English
EXCLUSION CRITERIA:
All Subjects will answer the NMR safety screening form and the Healthy volunteer form A subject will be excluded if he/she:
- Has any implanted medical device
- Underwent brain surgery, have a central nervous system illness, a neurological lesion or history of neurological or psychiatric disorders
- Medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, history of sleep apnea
- Diagnosable substance dependence
- Consumes more than 1 alcoholic drink per day for women and up to 2 drinks per day for men on a regular basis
- Has any metal in their body due to by trauma or surgery
- Cannot lie comfortably on their back for up to 60 minutes
- Is pregnant
- Have sustained shrapnel injuries
- Has worked as a machinist, or other occupations that have resulted in metal shavings in their eye
- Has claustrophobia
- Has known hearing problems
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
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 |
時間枠 |
|---|---|
|
Neuropsychological tests
時間枠：2 years
|
2 years
|
|
Physiological parameters
時間枠：2 years
|
2 years
|
|
Subjective experience parameters
時間枠：2 years
|
2 years
|
協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
キーワード
その他の研究ID番号
- 150057
- 15-N-0057
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。