- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02801643
The Impact of Reward-induced Dopamine Release on Functional Connectivity: a Combined PET/fMRI Study
연구 개요
상태
정황
상세 설명
Aim 1. To test the relationship between reward-induced dopamine (DA) release on changes in resting state functional connectivity (RSFC) in healthy subjects. In 20 healthy adults, the investigators will examine DA release (measured using positron emission tomography, PET) in the ventral striatum, thalamus, and prefrontal cortex, as previously described. Before and after the task the investigators will examine RSFC (measured using functional magnetic resonance imaging, fMRI) between these structures, which have been shown to form functional pathways serving motivation and emotion regulation in rodents and nonhuman primates. The investigators hypothesize that DA release will impact the functional relationship between these and other structures as determined by changes in RSFC.
Aim 2. To examine the relationship between dopamine release and the Reward Positivity (RewP) potential. Subjects will be presented with the option to participate in an event-related potential (ERP) study. The investigators will correlate the amount of DA release with the amplitude of the RewP potential, an ERP that is enhanced in reward versus non-reward circumstances. Based on previous studies, the investigators hypothesize that RewP amplitude will positively correlate with dopamine release in the nucleus accumbens.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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New York
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Stony Brook, New York, 미국, 11794
- Health Sciences Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Healthy men and women age 18-45 who have the capacity to consent to the protocol.
- Ability to understand and follow instructions and oriented to name, time, and place.
- A negative urine pregnancy and toxicology screen
- Willingness to abstain from using aspirin, NSAIDs, or anticoagulants during the study
Exclusion Criteria:
- Left-handed or ambidextrous
- History of seizures
- History of strokes
- Clinically significant, uncontrolled liver, kidney, cardiac, or pulmonary disease
- Terminal medical diagnosis consistent with survival < 1 year
- Serious mental impairment. Mini mental state exam of < 23/30
- Current or past DSM-IV Axis I or neurologic disorders
- Actively abusing substances, including alcohol (regular alcohol use during the past 6 months equal to or greater than 16 cans of beer per week or equivalent; use of street drugs or regular tobacco use during the past 6 months)
- Unstable medical condition (≥ 3 months), or serious medical illnesses during the past three months (e.g., serious infections)
- Unexplained loss of consciousness; history of traumatic brain injury involving loss of consciousness greater than 2 minutes
- Currently pregnant or breastfeeding, sexually active and of child-bearing potential and not using adequate contraceptive methods
- Childbirth or miscarriage during past 6 months, breastfeeding within 6 months of recruitment
- Allergic to latex and/or study pharmaceuticals
- Diabetes and/or unable to fast for up to 7 hours
- Unable to lie comfortably in the scanner for up to 4 consecutive hours
- Would receive a total of over 5 rems to a radiosensitive organ (bone marrow, gonads, lens of the eye) or 15 rems to any other organ or to the body as a whole during a 12 month period
- Contraindications for MRI including neurostimulators, implanted medical devices, metal in the body, claustrophobia, weight over 440 pounds, and girth size incompatible for scanner bore.
- Participation in a similar Social Feedback Task within 2 months of the start of the study.
공부 계획
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디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Dopamine receptor binding potential
기간: 1-3 weeks
|
changes in dopamine receptor binding potential will be measured during and after a reward task or social stimulus task
|
1-3 weeks
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Resting state fMRI
기간: 1-3 weeks
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Resting state functional connectivity will be measured using fMRI
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1-3 weeks
|
Event-related potential (ERP) during reward
기간: 1-3 weeks
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ERP during a reward task is measured
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1-3 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .