NCT05239780 Invasive Decoding and Stimulation of Altered Reward Computations in Depression Patients
| NCT ID | NCT05239780 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2021-10-06 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2021-10-06 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria: \- The study will follow clinical criteria for epilepsy patient recruitment for invasive monitoring. As a results, individuals of adults of all ages are expected to be included in this study. 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 frontal lobes continues through adolescence and significant differences in frontal lobe functioning between children younger than 18 and adults are often observed.
Contact & Investigator
Ignacio Saez, Ph.D.
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT05239780 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05239780 currently recruiting?
Yes, NCT05239780 is actively recruiting participants. Contact the research team at lizbeth.nunezmartinez@mssm.edu for enrollment information.
Where is the NCT05239780 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05239780 clinical trial?
NCT05239780 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Ignacio Saez, Ph.D. at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 10 participants.