신경성 폭식증에 대한 식사 중 뉴로피드백
식사 중 뉴로피드백: 신경성 폭식증에 대한 새로운 기계적 치료법
The purpose of this study is to examine the effects of noninvasive prefrontal cortex (PFC) neurofeedback during eating in women with bulimia nervosa (BN) using a wearable brain imaging device, functional near-infrared spectroscopy (fNIRS). The investigators will examine how this training may influence inhibitory control and BN symptoms.
연구 개요
상세 설명
The purpose of this study is to examine the effects of PFC neurofeedback during eating in women with bulimia nervosa (BN) using fNIRS. Specifically, the study aims 1) to demonstrate ventrolateral PFC (vlPFC) neurofeedback target engagement in women with BN using fNIRS; and 2) to link changes in PFC activation to changes in inhibitory control and eating-related symptoms.
Data will be collected from women with BN who will be randomly assigned to one of two group conditions (real or sham-control neurofeedback during eating). Participation includes a phone screening assessment, psychodiagnostic assessment, one in-person evaluation, one neurofeedback session, behavioral tasks, online questionnaires before and after the neurofeedback session, and a remote follow-up assessment.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Laura A Berner, Ph.D.
- 이메일: laura.berner@mssm.edu
연구 연락처 백업
- 이름: Sila Sozeri, B.A.
- 전화번호: (212) 201-2679
- 이메일: sila.sozeri@mssm.edu
연구 장소
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New York
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New York, New York, 미국, 10027
- 모병
- Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai
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수석 연구원:
- Laura A. Berner
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria:
- Female
- Aged 18 to 45 years
- Meet diagnostic criteria for bulimia nervosa
- Current body mass index greater than or equal to 18.5kg/m2 but under 30kg/m2
- English-speaking
Exclusion criteria:
- Ongoing medical treatment, major medical condition, or psychiatric disorder that may interfere with study variables or participation
- Current psychotherapy focused primarily on eating disorder symptoms
- Pregnancy or planned pregnancy, or lactation during the study period
- Allergy to ingredients in the standardized meal or in the shake
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Real fNIRS Neurofeedback Arm
Participants assigned to the experimental arm will see their true, real-time brain activation (i.e., active real-time neurofeedback) during the neurofeedback session. This activation will be displayed to the participant as a thermometer that will increase as brain activation in the target region increases. |
Participants will be instructed to use real-time fNIRS neurofeedback to non-invasively regulate neural activation associated with symptoms in individuals with bulimia nervosa. During the training, participants will view images on a computer screen, listen to sounds, and consume a shake. |
|
가짜 비교기: Sham-Control fNIRS Neurofeedback Arm
Participants assigned to the sham-control arm will see false feedback (or a fake signal) that is not connected to their right vlPFC activation during the neurofeedback session. |
Participants will be instructed to use sham real-time fNIRS neurofeedback to non-invasively regulate neural activation associated with symptoms in individuals with bulimia nervosa. During the training, participants will view images on a computer screen, listen to sounds, and consume a shake. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity
기간: approximately 1 hour
|
The investigators will evaluate changes in PFC neural activation and connectivity as a function of neurofeedback. |
approximately 1 hour
|
|
Go/no-go task performance
기간: 2 weeks
|
Participants will complete a go/no-go task 1 week before and 1 week after the neurofeedback session to measure inhibitory control. Participants behavioral performance on the go/no-go task will be determined by the percentage of incorrect responses made as they are prompted to react to different pictorial stimuli. Participants' percentages of error can range from 0% to 100%. A higher percentage indicates a lower behavioral performance on the task. |
2 weeks
|
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Number of loss-of-control eating and purging episodes
기간: 2 weeks
|
Frequency of loss-of-control eating and purging episodes. Participants will self-report on how often loss-of-control eating and purging episodes occur using electronic daily diaries in the week before and the week after the neurofeedback session. |
2 weeks
|
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Severity of loss-of-control eating scale
기간: 2 weeks
|
Severity of loss-of-control eating. Participants will rate the severity of their feelings of control over eating and purging episodes on a Likert-type scale from 0-10. Higher score indicates greater severity of loss of control. |
2 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Laura A Berner, Ph.D., Icahn School of Medicine at Mount Sinai
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- GCO 21-2078
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD 공유 기간
Immediately following publication and ending 5 years following article publication.
IPD 공유 액세스 기준
Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to laura.berner@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years after article publication via direct request to the investigator.
IPD 공유 지원 정보 유형
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .