Actively Recruiting
DBS for Depression
Led by Baylor College of Medicine · Updated on 2025-05-14
12
Participants Needed
2
Research Sites
365 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
U
University of Texas
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of the study is to address the unmet need of TRD patients by identifying brain networks critical for treating depression and to use next generation precision DBS with steering capability to engage these targeted networks. The study's goal will be achieved through 3 specific aims: 1. Demonstrate device capability to selectively and predictably engage distinct brain networks 2. Delineate depression-relevant networks and demonstrate behavioral changes with network-targeted stimulation 3. Demonstrate that chronic DBS using steered, individualized targeting is feasible and safe for reducing depressive symptoms
CONDITIONS
Official Title
DBS for Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and non-pregnant women between ages 22 and 70
- Diagnosed with major depressive disorder (MDD) as primary diagnosis, with a current major depressive episode
- Chronic illness with current major depressive episode lasting 24 months or more, or recurrent illness with at least 2 lifetime episodes
- Treatment-resistant depression with failure to respond to at least four adequate treatments from two different medication categories
- Previous trial of electroconvulsive therapy (ECT), with no response, relapse, poor tolerance, or refusal after discussion
- Hamilton Depression Rating Scale-17 item (HDRS17) score of 20 or higher at screening and one week before surgery
- Montgomery Asberg Rating Scale (MADRS) score of 27 or higher one week before surgery
- At least 6 weeks of psychotherapy without sustained response
- Brain MRI within 3 months prior to enrollment showing no findings that preclude participation
- Stable antidepressant medication regimen for at least one month before surgery
- Modified mini-mental state examination (MMSE) score of 24 or higher
- Normal thyroid stimulating hormone (TSH) level within 12 months of study entry
- No medical or physical conditions likely to prevent participation for the study duration
- Able and willing to give informed consent and attend regular clinic visits for at least 12 months after surgery
- Must have a treating psychiatrist, family member, caregiver, or person known present at screening visit for consent discussion
- Willingness to sign a treatment contract
- Agree to regular psychiatric follow-up and allow communication between researchers and healthcare providers throughout the study
You will not qualify if you...
- Any lifetime history of psychotic disorders such as schizophrenia or schizoaffective disorder
- Bipolar disorder with rapid cycling or recent manic episode requiring hospitalization within 5 years
- Clinically significant Cluster A or B personality disorders
- Alcohol or substance use disorder within the past 6 months, excluding nicotine
- Positive urine drug test for illicit substances
- Evidence of suicidal intent, attempts, or behavior within the past year
- Neurological or medical conditions making surgery unsafe (e.g., neurodegenerative disorders, serious cardiopulmonary disease)
- History of seizure disorder, hemorrhagic stroke, or high seizure risk
- Medical contraindications to surgery such as infection
- Bleeding disorders or abnormal clotting test results
- Blood pressure of 180/110 mmHg or higher with cardiovascular disease
- Participation in another clinical trial within 90 days
- Current implanted stimulation devices such as pacemakers or neurostimulators
- Pregnant or plans to become pregnant within 24 months
- Need for MRI or diathermy during the study
- Chronic use of anticoagulant or anti-platelet drugs that cannot be stopped safely around surgery
- Any other psychiatric, neurological, or medical conditions judged to make participation unsafe or unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Texas Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
2
Baylor College of Medicine
Houston, Texas, United States, 77030
Active, Not Recruiting
Research Team
S
Sameer A Sheth, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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