Repeated Real-time Biofeedback With 7-Tesla MRI for Treatment of Depression
연구 개요
상세 설명
Major depressive disorder (MDD) is one of the world's largest health problems with current treatments that are ineffective for a substantial proportion of individuals. There is a critical need for mechanistically informed interventions that are individualized and that aim to target core symptoms.
Converging evidence from animal and human research in the field has implicated the ventral tegmental area (VTA), a key component of the brain's dopamine system, in regulating motivation and reward-related behaviour. Previous work has demonstrated that participants can successfully train to self-regulate their VTA activity using cognitive strategies while receiving real-time feedback. This shows that VTA self-regulation is feasible in humans.
The current study builds on this previous work to further investigate the relationships between VTA activity modulation and mood and motivation related changes in individuals with MDD. Specifically, this study will aim to extend on prior findings by increasing the sample size and incorporating repeated training sessions to enhance and characterize training effects over time. A total of 60 participants with MDD will be recruited and will be randomized in a 1:1 ratio to receive either active biofeedback or sham (control) feedback.
Participants will complete two training sessions with real-time 7T-MRI biofeedback. During functional MRI (fMRI) scanning, participants will be trained to use self-generated cognitive strategies to modulate their VTA activity while viewing a visual representation of their brain signal (active condition) or a yoked control signal (sham condition).
The primary objective of this study is to determine how VTA modulation influences mood and motivation related measures over time. Secondary objectives include assessing changes in VTA activation and functional connectivity over time, as well as examining how neural changes relate to mood and motivation-related changes.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Laurel S Morris, Dr
- 전화번호: 01865 (6)16577
- 이메일: laurel.morris@ndcn.ox.ac.uk
연구 장소
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Oxford, 영국, OX39DU
- 모병
- Oxford Centre for Integrative Neuroimaging (OxCIN) FMRIB, Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Male or female aged 18-65 years;
- Meets DSM-5 criteria for major depressive disorder (MDD) as determined by the Structured Clinical Interview for DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI); with a current major depressive episode.
- Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.
Exclusion Criteria:
- Current or history of schizophrenia or other psychotic disorder, neurodevelopmental disorder, neurocognitive disorder or cognitive impairment
- Active substance use disorder within the past 1 year;
- Any unstable medical illnesses;
- Women who are pregnant;
- Any contraindications to MRI
- Antidepressant medication initiated within 2 weeks of the Baseline Assessment and concomitant use of any other medication with central nervous system activity during active participation;
- Active suicidal intent or plan.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Active Biofeedback
The participants in the active group will receive repeated active biofeedback training sessions.
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The active biofeedback session will be done within the 7T MRI.
It will include MOTIVATE and active rest trials.
During each MOTIVATE trial, subjects will be instructed to generate a heightened state of motivation.
Subjects will simultaneously view a progress bar on the screen during MOTIVATE trials that represents their VTA activity and they will be trained to try to increase the level of the bar by motivating themselves.
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가짜 비교기: Sham Biofeedback
The participants in the sham group will receive repeated sham biofeedback training sessions.
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The sham biofeedback session resembles the active condition, however, the progress bar seen during the MOTIVATE trials will represent yoked sham values.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mood and Motivation Related Measures
기간: Pre to post biofeedback training, within a 6-week timeframe.
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A single composite metric will be derived by factor analysis of a battery of validated mood and motivation related instruments (e.g.
PANAS-SF, POMS-SF, PHQ-9, MAP-SR), providing one expected latent mood and motivation factor.
Modelling the instruments jointly avoids nominating any single scale as the outcome, and controls for multiple comparisons.
Unit of measure: standardized latent factor score (z / SD units).
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Pre to post biofeedback training, within a 6-week timeframe.
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VTA Connectivity
기간: Pre to post biofeedback training, within a 4-week timeframe.
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Functional connectivity between the VTA seed and whole-brain (voxelwise), measured with 7-Tesla fMRI.
Unit of measure: Fisher z-transformed correlation coefficient.
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Pre to post biofeedback training, within a 4-week timeframe.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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VTA Activation
기간: Pre to post biofeedback training, within a 4-week timeframe.
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Blood-oxygen-level-dependent (BOLD) signal in the bilateral ventral tegmental area (VTA) region of interest for MOTIVATE versus active rest trials, measured with task-based 7-Tesla fMRI.
Unit of measure: percent BOLD signal change.
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Pre to post biofeedback training, within a 4-week timeframe.
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Association between change in VTA measures and change in the mood and motivation factor
기간: Pre to post biofeedback training, within a 6-week timeframe.
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The standardized VTA activation and connectivity measure will each be tested for an association with change in the mood and motivation factor.
One coefficient is reported per VTA measure.
Unit of measure: standardized regression coefficient (dimensionless, from -1 to 1).
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Pre to post biofeedback training, within a 6-week timeframe.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mood and Motivation EMA
기간: Pre to post biofeedback training, within a 6-week timeframe.
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Single-item mood and motivation ecological momentary assessment (EMA).
Unit of measure: arbirary likert rating.
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Pre to post biofeedback training, within a 6-week timeframe.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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 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. .
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