Invasive Decoding and Stimulation of Altered Reward Computations in Depression

Last updated: May 6, 2025
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Active - Recruiting

Phase

N/A

Condition

Affective Disorders

Mood Disorders

Depression

Treatment

Brain stimulation

Clinical Study ID

NCT05239780
STUDY-17-00258
1R01MH124763-01
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The study will follow clinical criteria for epilepsy patient recruitment forinvasive monitoring. As a results, individuals of adults of all ages are expected tobe included in this study.

Exclusion

Exclusion Criteria:

  • Adults over 80 years of age will be excluded as per concerns of cognitive decline.

  • Children under 18 will be excluded from the study since the maturation of frontallobes continues through adolescence and significant differences in frontal lobefunctioning between children younger than 18 and adults are often observed.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Brain stimulation
Phase:
Study Start date:
October 06, 2021
Estimated Completion Date:
August 31, 2027

Study Description

Participants (n=24) will complete a decision-making task in which participants will make decisions under uncertainty and seek to maximize rewards. The researchers will assess behavioral (risk attitudes) and neural (LFP) responses using a combination of intracranial recordings and computational modeling. A subset of patients will complete the game a second time under electrical stimulation of pre-identified anatomical targets in orbitofrontal cortex, hippocampus or amygdala. In addition, patients' depression status will be assessed through questionnaires (BDI-II and HDSA). Finally, the researchers will examine whether electrical stimulation results in behavioral or mood modulation.

Connect with a study center

  • Icahn School of Medicine at Mount Sinai

    New York, New York 100119
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.