Brain zaps for depression: scientists hunt for clues in electrical signals
NCT ID NCT05773755
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests deep brain stimulation (DBS) in 20 people with severe depression that hasn't improved with other treatments. The device delivers electrical pulses to a brain region called the subcallosal cingulate, which may reset mood circuits. Researchers will record brain signals to find markers that predict who responds best, aiming to personalize future therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Deep brain stimulation (DBS) device
- What this could lead to
- If successful, this could help doctors better adjust DBS settings for each patient, improving depression treatment outcomes.
- What could go wrong
- This is a small, early-stage study with only 20 participants, and it is not designed to prove the treatment works. Risks include surgery complications and unknown long-term effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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25 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 25-70 years old. * Ability to provide written informed consent. * Primary psychiatric diagnosis of Major Depressive Disorder (MDD), either single episode or recurrent type, without psychotic features, currently experiencing a Major Depressive Episode (MDE), as diagnosed by Structured Clinical Interview for DSM IV-TR or DSM-5 (SCID-IV or SCID-5). Two independent psychiatrists will confirm the diagnosis, as well. * Current depressive episode of at least two years duration OR a history of more than 3 lifetime depressive episodes. * Minimum score at study entry of 20 on the 17-item Hamilton Depression Rating Scale * Average pre-operative HDRS-17 score of 20 or greater (averaged over four weekly pre-surgical evaluations during the four weeks prior to surgery) * A maximum Global Assessment of Functioning of 50 or less. * Confirmed to have treatment-resistant depression (TRD). Treatment-resistance will be defined as failure to respond to at least four adequate antidepressant treatments (assessed with the Antidepressant Treatment History Form \[ATHF-SF\] and verified through medical records) during the current episode. Treatments which support study inclusion include antidepressive medications, certain augmentation agents, evidenced-based psychotherapy, and neuromodulation (ECT, transcranial magnetic stimulation (TMS)). For those patients who have not received ECT, patients may be considered eligible for study participation if they have received adequate trials of an SSRI, SNRI, augmentation agent (certain atypical antipsychotic medications, Lithium), and TMS and/or ketamine. * ability comply with study and device management procedures. Exclusion criteria: * Other primary Axis I conditions * Active suicidal ideation with intent, suicide attempt within the last six months, more than three suicide attempts within the last two years, or serious suicide risk as determined by the study psychiatrists * Other primary neurological disorders or unstable medical illness * Conditions requiring anticoagulant therapy which cannot be discontinued for the perioperative period, as required * Pregnancy or plan to come pregnant during the study * Contraindications for general anesthesia, neurosurgery, or an MRI scan * Currently implanted with a cardiac pacemaker / defibrillator or other implanted electrical device which may interfere with DBS stimulator or the function of which may be impacted by its implantation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Icahn School of Medicine at Mount Sinai, Mount Sinai West
RECRUITINGNew York, New York, 10019, United States
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