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Mechanisms of Repeated Real-time Biofeedback With 7-Tesla MRI in Depression

29 oktober 2026 bijgewerkt door: University of Oxford

Previous work demonstrated that individuals are able to self-regulate their ventral tegmental area (VTA) activity using real-time biofeedback. The current study expands this approach to a larger sample with repeated training sessions to more robustly characterize the effects of VTA modulation. This mechanistic study will assess change in mood and motivation-related measures, as well as neural activity and connectivity changes.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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, in a mechanistic manner. Specifically, this study will aim to extend on prior findings by increasing the sample size and incorporating repeated training sessions. 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 variation in VTA modulation is associated with mood and motivation related mechanisms that might change 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.

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigd Koninkrijk
      • Oxford, Verenigd Koninkrijk, OX39DU
        • Werving
        • Oxford Centre for Integrative Neuroimaging (OxCIN) FMRIB, Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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; as conducted in a research-based non-clinical setting.
  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Active Biofeedback

The participants in the active group will receive repeated active biofeedback training sessions.
Gedragsmatig: Active Biofeedback

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.
Sham-vergelijker: Sham Biofeedback

The participants in the sham group will receive repeated sham biofeedback training sessions.
Gedragsmatig: Sham Biofeedback

The sham biofeedback session resembles the active condition, however, the progress bar seen during the MOTIVATE trials will represent yoked sham values.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mood and Motivation Related Mechanistic Measures
Tijdsspanne: Pre to post biofeedback training, within a 6-week timeframe.

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, MAP-SR), providing one expected latent mood and motivation factor. Modelling the instruments jointly avoids nominating any single scale as the mechanistic outcome, and controls for multiple comparisons. Unit of measure: standardized latent factor score (z / SD units).
Pre to post biofeedback training, within a 6-week timeframe.
VTA Connectivity
Tijdsspanne: Pre to post biofeedback training, within a 4-week timeframe.

Functional connectivity between the VTA seed and whole-brain (voxelwise), measured with 7-Tesla fMRI. Unit of measure: Fisher z-transformed correlation coefficient.
Pre to post biofeedback training, within a 4-week timeframe.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
VTA Activation
Tijdsspanne: Pre to post biofeedback training, within a 4-week timeframe.

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.
Pre to post biofeedback training, within a 4-week timeframe.
Association between change in VTA measures and change in the mood and motivation factor
Tijdsspanne: Pre to post biofeedback training, within a 6-week timeframe.

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).
Pre to post biofeedback training, within a 6-week timeframe.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mood and Motivation EMA
Tijdsspanne: Pre to post biofeedback training, within a 6-week timeframe.

Single-item mood and motivation ecological momentary assessment (EMA). Unit of measure: arbitrary likert rating.
Pre to post biofeedback training, within a 6-week timeframe.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Oxford

Medewerkers

Wellcome Trust

Onderzoekers

  • Hoofdonderzoeker: Laurel S Morris, Dr, University of Oxford

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 december 2026

Primaire voltooiing (Geschat)

1 juni 2031

Studie voltooiing (Geschat)

1 juni 2033

Studieregistratiedata

Eerst ingediend

4 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 juli 2026

Eerst geplaatst (Werkelijk)

9 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

29 oktober 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MS IDREC 879781
  • 226532/Z/22/Z (Ander subsidie-/financieringsnummer: Wellcome Trust)

Plan Individuele Deelnemersgegevens (IPD)

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ONBESLIST

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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