Invasive Decoding and Stimulation of Altered Reward Computations in Depression Patients

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Minor Trial completed Show 5 more changesShow less
    • Final enrollment: 24 participants (planned 10)
    • Primary completion date changed from estimate of Aug 31, 2027 to May 12, 2026
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised
    • Eligibility criteria expanded, about 2 words
  2. Minor Study title expanded, about 1 wordv6
  3. Notable Primary completion date: Aug 31, 2025 to Aug 31, 2027v5
  4. Notable Primary completion date: Aug 2027 to Aug 31, 2025
    • Study completion date: Aug 2027 to Aug 31, 2027
    v4
  5. 2 versions Re-verified since Mar 6, 2023, no change to tracked fieldsv2-v3
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novel invasive neurostimulation stimulation strategies through neurosurgical interventions are emerging as a promising therapeutical strategy for major depressive disorder. These have been applied mostly to the anterior cingulate cortex, but other limbic brain regions have shown promise as anatomical targets for new neurostimulation strategies. The researchers seek to study neural activity in limbic brain areas implicated in decision behavior and mood regulation to identify novel targets for treatment through electrical stimulation. To do this, the study team will record local field potentials (LFPs) from the orbitofrontal cortex, hippocampus and amygdala of epilepsy participants undergoing invasive monitoring (intracranial encephalography, iEEG) during choice behavior. Leveraging the high co-morbidity of depression and intractable epilepsy (33-50%), neural responses will be compared to reward across depression status to identify abnormal responses in depression. Finally, the researchers will use these as biomarkers to guide development of neurostimulation strategies for the treatment of depression.
Trial Details
NCT Number NCT05239780
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: University of California, Davis, National Institute of Mental Health (NIMH)
Conditions
(from sponsor)
Major Depressive Disorder
Related terms Major Depressive Disorder
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov