Actively Recruiting
Closed-Loop Deep Brain Stimulation for Major Depression
Led by Andrew Krystal · Updated on 2023-05-01
12
Participants Needed
1
Research Sites
832 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Closed-Loop Deep Brain Stimulation for Major Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22-70
- Diagnosis of Major Depressive Disorder (MDD) without psychosis with current episode lasting 2 or more years
- Treatment-resistant MDD with at least 4 adequate treatment trials including electroconvulsive therapy (ECT), 3 medication classes, one augmentation strategy, and psychotherapy
- Failed ECT due to inability to sustain response or intolerable side effects
- Montgomery-Åsberg Depression Rating Scale (MADRS) score greater than 26 at baseline and screening
- Variability in depression rating scales (minimum 2-point variation on HAMD-6 administered 3 times daily for 3 days)
- Stable psychotropic medication regimen for 4 weeks prior to and during study participation
- Willing and able to undergo invasive brain recording and stimulation
- Willing and able to attend multiple research visits and perform at-home study activities
- Able to provide informed consent
- Ability to speak and read English
You will not qualify if you...
- Diagnosis of psychotic disorder, eating disorder, panic disorder, posttraumatic stress disorder, bipolar disorder, obsessive compulsive disorder, tic disorder, or other psychiatric disorders except MDD or generalized anxiety disorder
- Generalized anxiety disorder as the primary disorder in the current MDD episode
- Active suicidal thoughts with intent and plan
- Suicide attempt requiring hospitalization within previous 2 years
- Alcohol or substance abuse or dependence (other than caffeine) within previous 6 months
- Personality disorder impacting compliance or safety
- Fibromyalgia or chronic fatigue syndrome
- Chronic narcotic use
- History of traumatic brain injury, neurological disorders, or developmental delay
- History of seizures
- Significant MRI abnormalities within the last year
- Previous brain surgery involving ablative or deep brain stimulation
- Implantable hardware incompatible with MRI or study
- Major medical conditions increasing surgery risk including severe diabetes, organ failure, recent stroke, infection, cardiovascular disease, immunocompromised state, or malignancy with less than 5 years life expectancy
- Inability to stop certain blood-thinning medications for surgery
- Coagulopathy without hematology clearance
- Allergies to materials in the NeuroPace RNS System
- Living alone without caregiver support after hospital stay
- Inability to comply with study visits
- Pregnancy, planning pregnancy, or breastfeeding
- Inability to speak or read English
- Inability to give consent
- Significant cognitive impairment or dementia (MoCA score below 25)
- Likely to require electroconvulsive therapy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
K
Katherine Scangos, MD, PhD
CONTACT
R
Rebecca Martinez, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here