Visando redes de grande escala na depressão com neurofeedback de imagem por ressonância magnética funcional em tempo real (fMRI)
Visando redes de grande escala na depressão com neurofeedback fMRI em tempo real
The purpose of this study is to develop a technique called real time fMRI neurofeedback.
This technique uses a regular MRI scanner, except that special software allows the researchers to measure activity in participants brain, using fMRI, and then give information, in the form of a feedback signal, which indicates brain activity in real time, while in the MRI scanner. The larger goal of this study is to develop ways to help people, including those with depression, better regulate brain activity. The researchers think that this may be helpful in managing psychiatric symptoms.
This study design has three phases, however, only two phases (phase 2 and 3) are considered to be a clinical trial. Phase 2 (part 2) was registered and is NCT05934604. This is the phase 3 (part 3) for this project and is funded by the National Institutes of Health.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Part 3/Phase 3 study hypothesis are:
- Rest Focus Task (RFT) will activate brain networks at the individual subject level to provide a viable signal for Neurofeedback (NF)
- At the group level, RFT in the Active>Passive contrast will activate canonically defined salience network
- Neurofeedback-reinforced practice over the session will increase RFT activation over the course of the training session, comparing RFT activation, without NF, before and after NF runs.
- Valid Neurofeedback will increase RFT activation more compared to sham NF (assessed during the no-NF session).
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Meets The Diagnostic and Statistical Manual of Mental Disorders five (DSM5) criteria for Major Depressive Disorder, single or recurrent, active or in partial remission
- Patient Health Questionnaire (PHQ9) greater or equal (≥)6, and approximately (~) 50% with PHQ9≥10
- If participants are taking antidepressant medications, on stable dosage for 4 weeks
- No history of active substance use disorder in the past 6 months
- Absence of suicidal thoughts with plans or intentions, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
- If a woman of child-bearing age, not pregnant or trying to become pregnant
- Ability to tolerate small, enclosed spaces without anxiety
- No metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition, e. g. aneurysm clips, retained particles (for example metal workers with exposures, protocol has more details), etc.
- Size compatible with scanner gantry (per protocol)
- Ability and willingness to give informed consent to participate.
Exclusion Criteria:
- Size not compatible with scanner
- Not meeting diagnostic criteria for bipolar disorder, schizophrenia, other psychosis, obsessive-compulsive disorder, active eating disorder or Post-traumatic stress disorder (PTSD)
- No history of serious neurological illness (including, but not limited to, seizures/epilepsy) or current medical condition that could compromise brain function, such as liver failure
- No history of closed head injury, e. g. loss of consciousness > ~5 min, hospitalization, neurological sequela
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Falso: Sham controlled feedback
Subjects will complete three visits with one or two fMRI sessions after initial assessment and training visit. The first session will be to introduce practice tasks using the mock scanner. In the second visit participants will have an fMRI. The study team will review the fMRI results to decide if participants will continue on the study (must exhibit a specific pattern of activation) and have the second fMRI at the third visit. |
During the second fMRI, the study will introduce the real time fMRI neurofeedback part of the study. This is where subjects will use the activity from the brain to control the size of the circular pattern viewed in the first two visits. This is real time fMRI because the pattern will change, in real time, based on what the fMRI scan measures in the brain. Participants will be encouraged to make the circular pattern grow in size, just by thinking about it. In order to see if the neurofeedback is really helping change the size of the circular pattern, the study team will have a control condition. In this controlled condition, subjects will see the circular pattern change, and the study team will ask participants to try and increase the size, except that the changing size will not actually be determined by your brain activity. This a called a sham condition because the feedback signal is not real. |
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Experimental: Real-time neurofeedback
Subjects will complete three visits with one or two fMRI sessions after initial assessment and training visit. The first session will be to introduce practice tasks using the mock scanner. In the second visit participants will have an fMRI. The study team will review the fMRI results to decide if participants will continue on the study (must exhibit a specific pattern of activation) and have the second fMRI at the third visit. |
During the second fMRI, the study will introduce the real time fMRI neurofeedback part of the study. This is where subjects will use the activity from the brain to control the size of the circular pattern viewed in the first two visits. This is real time fMRI because the pattern will change, in real time, based on what the fMRI scan measures in the brain. Participants will be encouraged to make the circular pattern grow in size, just by thinking about it. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Blood Oxygen Level Dependent (BOLD) signal change during the active > passive contrast during the localizer session
Prazo: Approximately 40 minutes (during MRI)
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Using standard pre-processing pipelines, the general linear model, convolved with the hemodynamic response function, will be used to predict change in BOLD signal for the contrast of the active compared to the passive conditions. Z-transformed t-statistics will be corrected for multiple comparisons in the region of interest (salience network) |
Approximately 40 minutes (during MRI)
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BOLD signal change during the active>passive contrast, comparing baseline with transfer runs (no NF in either), during the real time functional magnetic resonance imaging neurofeedback (rtfMRI-NF) session
Prazo: Approximately 40 minutes (during MRI)
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Same processing as outcome measure 2, except the contrast of active>passive will itself be contrasted within the session (baseline compared to transfer run) |
Approximately 40 minutes (during MRI)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Stephan Taylor, MD, University of Michigan
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HUM00228741 phase 3
- 1R21MH134035-01 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
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