Trial Summary
What is the purpose of this trial?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
Is Directional Deep Brain Stimulation a promising treatment for depression?Yes, Directional Deep Brain Stimulation is a promising treatment because it can better target specific areas in the brain, potentially improving benefits and reducing side effects compared to traditional methods.12457
Do I have to stop taking my current medications for the trial?The protocol does not specify if you must stop taking your current medications. However, you must have a stable antidepressant medication regimen for the month before surgery.
What safety data is available for Deep Brain Stimulation for Depression?The safety data for Deep Brain Stimulation (DBS), including Directional Deep Brain Stimulation (dDBS), indicates that directional leads can improve the therapeutic window by reducing side effects and enhancing clinical benefits. Studies have shown that directional leads allow for more precise targeting, potentially minimizing adverse effects by steering electrical currents away from sensitive areas. However, the complexity of programming these leads requires careful consideration of lead orientation and patient anatomy. Overall, directional DBS has been suggested to have similar therapeutic effects to traditional DBS but with improved safety profiles due to better control over stimulation direction.12357
What data supports the idea that Deep Brain Stimulation for Depression is an effective treatment?The available research shows that Deep Brain Stimulation (DBS) can be effective by improving clinical benefits and reducing side effects. Although the studies mainly focus on conditions like Parkinson's disease, they highlight that directional DBS can better target specific brain areas, which might also be beneficial for depression. For instance, in Parkinson's patients, directional DBS led to a 44% improvement in symptoms and reduced medication needs by 43% over six months. This suggests that DBS could potentially offer similar benefits for depression by precisely targeting brain regions involved in mood regulation.12567
Eligibility Criteria
This trial is for adults aged 22-70 with major depressive disorder (MDD) who haven't improved after trying at least four different depression treatments and ECT or psychotherapy. They must have a stable medication regimen, normal brain MRI, no bipolar or certain personality disorders, no recent substance abuse, and not be pregnant.Inclusion Criteria
I have been diagnosed with major depression as my main health issue.
I have undergone Electroconvulsive Therapy (ECT) before.
I've had at least 6 weeks of psychotherapy without feeling better.
My depression symptoms are severe, scoring 27 or higher on the MADRS.
I am between 22 and 70 years old and not pregnant.
My recent brain MRI does not show anything that would stop me from joining.
Exclusion Criteria
I have a health condition that makes surgery risky for me.
I cannot have surgery due to a medical condition like an infection.
I have bipolar disorder with rapid mood changes and was hospitalized for a manic episode in the last 5 years.
I have high blood pressure and heart disease.
I have a history of seizures or am at high risk for seizures.
Treatment Details
The study tests a new type of Deep Brain Stimulation (DBS) that directs electrical currents to specific brain networks linked to depression. It aims to show this method can change behavior by targeting these networks and is safe for long-term use in reducing symptoms of severe depression.
1Treatment groups
Experimental Treatment
Group I: Directional Deep Brain StimulationExperimental Treatment1 Intervention
Directional Deep Brain Stimulation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Deep Brain Stimulation for:
- Parkinson's disease
- Essential tremor
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
🇪🇺 Approved in European Union as Deep Brain Stimulation for:
- Parkinson's disease
- Essential tremor
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
🇨🇦 Approved in Canada as Deep Brain Stimulation for:
- Parkinson's disease
- Essential tremor
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
Find a clinic near you
Research locations nearbySelect from list below to view details:
Baylor College of MedicineHouston, TX
University of Texas SouthwesternDallas, TX
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Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
University of TexasCollaborator
References
Pilot Study for Considering Subthalamic Nucleus Anatomy during Stimulation Using Directional Leads. [2020]Directional leads are used for deep brain stimulation (DBS). Two of the four contacts of the leads are divided into three parts, enabling controlled stimulation in a circumferential direction. The direction of adverse effects evoked by DBS in the subthalamic nucleus (STN) and stimulation strategies using directional leads were evaluated.
Temporal Stability of Lead Orientation in Directional Deep Brain Stimulation. [2021]Directional deep brain stimulation (DBS) enlarges the therapeutic window by increasing side-effect thresholds and improving clinical benefits. To determine the optimal stimulation settings and interpret clinical observations, knowledge of the lead orientation in relation to the patient's anatomy is required.
Surgical Strategy for Directional Deep Brain Stimulation. [2022]Deep brain stimulation (DBS) is a well-established treatment for drug-resistant involuntary movements. However, the conventional quadripole cylindrical lead creates electrical fields in all directions, and the resulting spread to adjacent eloquent structures may induce unintended effects. Novel directional leads have therefore been designed to allow directional stimulation (DS). Directional leads have the advantage of widening the therapeutic window (TW), compensating for slight misplacement of the lead and requiring less electrical power to provide the same effect as a cylindrical lead. Conversely, the increase in the number of contacts from four to eight and the addition of directional elements has made stimulation programming more complex. For these reasons, new treatment strategies are required to allow effective directional DBS. During lead implantation, the directional segment should be placed in a "sweet spot," and the orientation of the directional segment is important for programming. Trial-and-error testing of a large number of contacts is unnecessary, and efficient and systematic execution of the programmed procedure is desirable. Recent improvements in imaging technologies have enabled image-guided programming. In the future, optimal stimulations are expected to be programmed by directional recording of local field potentials.
The actual use of directional steering and shorter pulse width in selected patients undergoing deep brain stimulation. [2022]Directional deep brain stimulation (DBS) and pulse with
Long-Term Clinical Experience with Directional Deep Brain Stimulation Programming: A Retrospective Review. [2022]Directional deep brain stimulation (d-DBS) axially displaces the volume of tissue activated (VTA) towards the intended target and away from neighboring structures potentially improving benefit and reducing side effects (SE) of stimulation. A clinical trial evaluating d-DBS demonstrated a wider therapeutic window (TW) with directional electrodes. While this seems advantageous, it remains unclear when and why directional stimulation is chosen clinically. To evaluate the implementation of d-DBS in our practice we examined the prevalence of and motivation for directional programming.
Real-Life Experience on Directional Deep Brain Stimulation in Patients with Advanced Parkinson's Disease. [2022]Directional deep brain stimulation (dDBS) is preferred by patients with advanced Parkinson's disease (PD) and by programming neurologists. However, real-life data of dDBS use is still scarce. We reviewed the clinical data of 53 PD patients with dDBS to 18 months of follow-up. Directional stimulation was favored in 70.5% of dDBS leads, and single segment activation (SSA) was used in 60% of dDBS leads. Current with SSA was significantly lower than with other stimulation types. During the 6-month follow-up, a 44% improvement in the Unified Parkinson's Disease Rating Scale (UPDRS-III) points and a 43% decline in the levodopa equivalent daily dosage (LEDD) was observed. After 18 months of follow-up, a 35% LEDD decrease was still noted. The Hoehn and Yahr (H&Y) stages and scores on item no 30 "postural stability" in UPDRS-III remained lower throughout the follow-up compared to baseline. Additionally, dDBS relieved non-motor symptoms during the 6 months of follow-up. Patients with bilateral SSA had similar clinical outcomes to those with other stimulation types. Directional stimulation appears to effectively reduce both motor and non-motor symptoms in advanced PD with minimal adverse effects in real-life clinical care.
An Institutional Experience of Directional Deep Brain Stimulation and a Review of the Literature. [2023]Directional deep brain stimulation (dDBS) has been suggested to have a similar therapeutic effect when compared with the traditional omnidirectional DBS, but with an improved therapeutic window that yields optimized clinical effect owing to the ability to better direct, or "steer," electric current. We present our single-center, retrospective analysis of our experience in the use of dDBS in patients with movement disorders and provide a review of the literature.