- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04950309
OPM(Optical Pumped Magnetometer) MEG(Magnetoencephalography) 어레이의 특성화
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....
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Anna M Namyst
- 전화번호: (301) 402-2445
- 이메일: anna.namyst@nih.gov
연구 연락처 백업
- 이름: Allison C Nugent, Ph.D.
- 전화번호: (301) 451-8863
- 이메일: nugenta@mail.nih.gov
연구 장소
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Maryland
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Bethesda, Maryland, 미국, 20892
- 모병
- National Institutes of Health Clinical Center
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연락하다:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- 전화번호: TTY8664111010 800-411-1222
- 이메일: prpl@cc.nih.gov
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 장치 타당성
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
array characterization metrics
기간: throughout protocol
|
At each phase of array construction characterization parameters including signal to noise, sensitivity, bandwidth, and spatial resolution will be measured. |
throughout protocol
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Somatotopic representations
기간: throughout protocol
|
Somatotopic representations of the digits of the hand, potentially differentiating the individual phalanx of each finger. |
throughout protocol
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Allison C Nugent, Ph.D., National Institute of Mental Health (NIMH)
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
MEG datasets ultimately used for publication will be shared.
IPD 공유 기간
Data analysis code may be shared at the time of publication.
IPD 공유 액세스 기준
Data will be shared without a specific DUA using an NIH supported online repository such as OpenNeuro.
IPD 공유 지원 정보 유형
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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