Closed-Loop Deep Brain Stimulation for Major Depression
Eligible age
22–70 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
Neurons are specialized types of cells that are responsible for carrying out the functions of the brain. Neurons communicate with electrical signals. In diseases such as major depression this electrical communication can go awry. One way to change brain function is using electrical stimulation to help alter the communication between groups of neurons in the brain. The purpose of this study is to test a personalized approach to brain stimulation as an intervention for depression. The study researchers will use a surgically implanted device to measure each individual's brain activity related to his/her depression. The researchers will then use small electrical impulses to alter that brain activity and measure whether these changes help reduce depression symptoms. This study is intended for patients with major depression whose symptoms have not been adequately treated with currently available therapies. The device used in this study is called the NeuroPace Responsive Neurostimulation (RNS) System. It is currently FDA approved to treat patients with epilepsy. The study will test whether personalized responsive neurostimulation can safely and effectively treat depression.
Sponsor: Andrew Krystal
You may qualify if…
- ✓ Age 22-70
- ✓ Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnostic criteria for Major Depressive Disorder (MDD) without psychosis based on a Structured Clinical Interview for DSM-V (SCID) with current episode ≥ 2 years that is treatment- resistant (4 adequate trials (including ECT), 3 classes of medications, one augmentation strategy, psychotherapy) as measured by the antidepressant treatment history form (ATHF).
- ✓ Failed electroconvulsive therapy (ECT) due to inability to achieve sustained response (2 failed attempts to discontinue ECT treatment) or discontinued due to intolerable side effects.
- ✓ Has MADRS score of \> 26 at both baseline and screening visit
- ✓ The presence of variability on repeated administrations of MDD rating scales (minimum of 2-point variation on the HAMD-6 administered 3 times a day for 3 days), which is required for the identification of a neural biomarker.
- ✓ If patient is on a regimen of psychotropic medication, no changes in this regimen should be made during the 4 weeks prior to entry into and the duration of the study.
- ✓ Willing and able to undergo invasive brain recording/stimulation study
- ✓ Willing and able to attend multiple research visits and perform at-home research protocol
You may not qualify if…
- ✕ Meets DSM-V criteria for a psychotic disorder, eating disorder, panic disorder, posttraumatic stress disorder, bipolar disorder, obsessive compulsive disorder, tic disorder, or another comorbid psychiatric disorder other than MDD or generalized anxiety disorder based on a SCID
- ✕ Generalized anxiety disorder is the primary DSM-V disorder during the current MDD episode
- ✕ Active suicidal ideation with intent and plan as defined by a score of 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS)
- ✕ History of suicide attempt requiring hospitalization in previous 2 years.
- ✕ Meets criteria for alcohol or substance abuse or dependence (other than caffeine) in previous 6 months, determined by the SCID
- ✕ Has a personality disorder based on the investigator's assessment that the investigator believes will adversely impact subject compliance or safety
- ✕ Fibromyalgia or chronic fatigue syndrome
- ✕ Current condition requiring chronic narcotic use
Where it's recruiting
San Francisco
Source: ClinicalTrials.gov · NCT04004169 · last updated 2026-08-03