光ポンピング磁力計 (OPM) 脳磁図 (MEG) アレイの特性評価
Background:
Brain activity produces magnetic fields. These fields can be measured outside the head. Existing technology, called MEG, measures these fields. Researchers are testing a new type of magnetic field sensor called OPM. They hope it can help pinpoint with very high accuracy where brain activity is generated.
Objective:
To develop and test a new type of sensor for measuring the magnetic fields produced by brain activity.
Eligibility:
Healthy people ages 18-70 who had a magnetic resonance imaging (MRI) scan under protocol 17-M-0181.
Design:
Participants may be asked to complete sessions on both the traditional MEG instrument and the OPM array.
For the MEG, 3-6 small coils will be placed on the participant s face with tape. Their head will be positioned inside the MEG device.
For the OPM, sensors are housed in a 3d printed array. The sensors will be attached to a cap placed on the participant s head.
For both scans, participants will be seated in a chair inside a magnetically shielded room. They may complete several tasks. In one task, plastic cells will be placed on their fingers. Puffs of air will be sent to these cells, which will stimulate the sense of touch. Other tasks may include the following stimuli: visual (such as checkerboards), auditory (such as beeps and tones), or language (words and letters).
Researchers may also obtain recordings while they stimulate the nerve in the participant s forearm using electrical current in small electrodes.
Participation is expected to last for 1 day. Additional optional scans may be offered for up to 1 year....
調査の概要
詳細な説明
Study Description:
This protocol is a technical development protocol to characterize an optically pumped magnetometer (OPM) array used for measuring magnetic brain signals. We hypothesize that with our OPM arrays, we can achieve similar or better spatial resolution to that of a conventional MEG system.
Objectives:
Primary Objective: To fully characterize the performance of an OPM MEG array at all stages of development.
Secondary Objective: To demonstrate that the OPM system can produce somatotopic maps, tonotopic maps, retinotopic maps, and/or maps of receptive language fields.
Tertiary Objective: To demonstrate the ability of the OPM system to obtain high SNR and high resolution maps of the cardiac cycle.
Endpoints:
Primary Endpoint: OPM array characterization parameters including signal to noise, sensitivity, bandwidth, and spatial resolution, and comparison to similar parameters acquired on a standard SQUID system.
Secondary Endpoint: Somatotopic representations of the digits of the hand, tonotopic mapping of tone frequency, mapping of visual receptive fields, and mapping of the receptive language system.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Anna M Namyst
- 電話番号：(301) 402-2445
- メール：anna.namyst@nih.gov
研究連絡先のバックアップ
- 名前：Allison C Nugent, Ph.D.
- 電話番号：(301) 451-8863
- メール：nugenta@mail.nih.gov
研究場所
-
-
Maryland
-
Bethesda、Maryland、アメリカ、20892
- 募集
- National Institutes of Health Clinical Center
-
コンタクト：
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- 電話番号：TTY8664111010 800-411-1222
- メール：prpl@cc.nih.gov
-
-
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:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-70
- In good general health as evaluated according to protocol 17-M-0181
- Completed a magnetic resonance imaging (MRI) scan under 17-M-0181
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Participants excluded from 17-M-0181 will be excluded from this protocol
- Metal in the body which would cause artifacts on MEG recordings
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
- 主な目的：デバイスの実現可能性
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：OPM Array studies
Testing of a final 49-144 channel OPM MEG system and any interim arrays |
MEG recordings acquired on a standard whole brain SQUID MEG system. Stimuli will be used, including auditory, visual, or somatosensory stimuli. Language stimuli and median nerve stimulation may also be used. MEG recordings acquired on an investigational OPM MEG system. Stimuli will be used, including auditory, visual, or somatosensory stimuli. Language stimuli and median nerve stimulation may also be used. |
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 |
|---|---|---|
|
array characterization metrics
時間枠：throughout protocol
|
At each phase of array construction characterization parameters including signal to noise, sensitivity, bandwidth, and spatial resolution will be measured. |
throughout protocol
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Somatotopic representations
時間枠：throughout protocol
|
Somatotopic representations of the digits of the hand, potentially differentiating the individual phalanx of each finger. |
throughout protocol
|
協力者と研究者
捜査官
- 主任研究者：Allison C Nugent, Ph.D.、National Institute of Mental Health (NIMH)
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
MEG datasets ultimately used for publication will be shared.
IPD 共有時間枠
Data analysis code may be shared at the time of publication.
IPD 共有アクセス基準
Data will be shared without a specific DUA using an NIH supported online repository such as OpenNeuro.
IPD 共有サポート情報タイプ
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。