- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02194907
Emotion Study -- A Neurofeedback Approach
Emotion Study -- Improving Neural Dysregulation in Advanced Age: A Neurofeedback Approach
연구 개요
상태
상세 설명
Overview: All participants of both age groups will be randomly divided (like tossing a coin) into two groups:
- One group will have training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain, while thinking of and viewing emotional faces, scenes, and text
- The other group will have training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain while thinking of and viewing emotional faces, scenes, and text
Further, each of these two groups will be divided into two sub-groups that are different with respect to the training procedure that is used:
* Use of a 3.0 Tesla, 32-channel Seimens whole-body human MR scanner (fMRI) during training, that has not been associated with any known side effects or safety risks
Number of Study Visits:
This study has the following parts: A pre-training visit, six training visits, and a post-training visit.
With a few exceptions as explained below, the procedures during pre-training, training, and post-training visits are identical.
- At the beginning of the first visit, the investigator will tell the participant about the study and what is involved and will ask them to sign a consent form. The participant may ask as many questions as they would like before deciding about study participation.
- For each of the visits, the investigator will review questions with the participant about their health to ensure their eligibility to undergo fMRI on the day of testing.
- Also for each visit, the investigator will ask the participant to respond to a short questionnaire related to their current mood.
- In the pre-training and the post-training visits only, the investigator will ask the participant to answer questions about their feelings, emotions, and thoughts.
- For each of the participant's visits, they will spend 50-60 minutes either in the MRI scanner, while viewing pictures and text on a screen. During this time, pictures of the participant's brain at work and at rest will be acquired. In the training visits only, the participant will learn to increase blood flow in certain brain regions with the help of information presented to them on the screen.
- For each of the participant's visits, they will be asked to respond to a short questionnaire related to their current mood.
- In the pre-training/post-training visits only, the investigator will ask the participant to answer questions about their feelings, emotions, and thoughts as well as their personality. The participant will also perform brief tests related to the thinking process.
- At the end of each visit, the participant will complete a questionnaire about how they approached the study tasks and whether they experienced any discomfort in the MRI scanner or while wearing the fNIRS system.
- Upon study completion, the investigator will tell the participant about the general goals of the study and answer any questions that they may have.
The procedure can be stopped at any time.
The study will conclude with debriefing and reimbursement.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Florida
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Gainesville, Florida, 미국, 32611-2250
- University of Florida
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Between the ages of 18-30 years or 63-90 years
- Right-handed
- Native English speaker
Exclusion Criteria:
- Pregnant or possibly pregnant
- Claustrophobia
- Large pieces of metal in the body, particularly in the face and neck.
- Piercings or metal implants that cannot be removed from the body
- Surgery on the brain or any prior serious brain damage or disease
- Dementia or severe cognitive disorders
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Anterior insula cortex activation
Participants will receive training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain, while thinking of and viewing emotional faces, scenes, and text.
|
training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain
|
|
활성 비교기: Primary auditory cortex activation
Participants will have training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain while thinking of and viewing emotional faces, scenes, and text.
|
training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Increased activation of anterior insula from pre-training to post-training
기간: Pre-training session (baseline visit); post-training session (approximately one week later)
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Both young and older participants can be trained in up-regulation of anterior insula activity, by means of contingent neurofeedback (rt-fMRI), reflecting continued plasticity of brain regions associated with affective processing.
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Pre-training session (baseline visit); post-training session (approximately one week later)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gained volitional control over activity in anterior insula improves emotion perception from pre-training to post-training
기간: Pre-training (baseline visit); post-training visit (approximately one week later)
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Participants in the experimental group compared to the control group will benefit more from neurofeedback, in that they will show relatively greater improvement in emotion perception after the rt-fMRI training, reflecting a potential for improvement of neural dysregulation related to affective processing.
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Pre-training (baseline visit); post-training visit (approximately one week later)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Natalie Ebner, PhD, University of Florida, Department of Psychology
간행물 및 유용한 링크
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. .
Brain activity training - anterior insula에 대한 임상 시험
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