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Repeated Real-time Biofeedback With 7-Tesla MRI for Treatment of Depression

6. juli 2026 opdateret af: 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. The study will assess change in mood and motivation-related measures, as well as neural activity and connectivity changes.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Det Forenede Kongerige
      • Oxford, Det Forenede Kongerige, OX39DU
        • Rekruttering
        • Oxford Centre for Integrative Neuroimaging (OxCIN) FMRIB, Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

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Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Active Biofeedback
The participants in the active group will receive repeated active biofeedback training sessions.
Adfærdsmæssigt: 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-komparator: Sham Biofeedback
The participants in the sham group will receive repeated sham biofeedback training sessions.
Adfærdsmæssigt: Sham Biofeedback
The sham biofeedback session resembles the active condition, however, the progress bar seen during the MOTIVATE trials will represent yoked sham values.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mood and Motivation Related Measures
Tidsramme: 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, 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).
Pre to post biofeedback training, within a 6-week timeframe.
VTA Connectivity
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
VTA Activation
Tidsramme: 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
Tidsramme: 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.

Andre resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Oxford

Samarbejdspartnere

Wellcome Trust

Efterforskere

  • Ledende efterforsker: Laurel S Morris, Dr, University of Oxford

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2031

Studieafslutning (Anslået)

1. juni 2033

Datoer for studieregistrering

Først indsendt

4. juni 2026

Først indsendt, der opfyldte QC-kriterier

6. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MS IDREC 879781
  • 226532/Z/22/Z (Andet bevillings-/finansieringsnummer: Wellcome Trust)

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Kliniske forsøg med Major Depressive Disorder (MDD)

Kliniske forsøg med Active Biofeedback

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