Deep Brain Stimulation for Anxiety Disorders
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how people learn fear in virtual reality (VR) settings and how their brain and body react during this process. Participants with an implanted brain device (RNS) for epilepsy will experience different VR environments and receive gentle electrical pulses to study fear responses. This research could lead to better treatments for anxiety disorders in the future. The trial seeks individuals who have the RNS device implanted and no history of brain injury. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve anxiety treatments.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this protocol is safe for individuals with an RNS device?
Research has shown that deep brain stimulation (DBS) is usually well-tolerated and can be a safe option for treating various conditions. One study found that DBS quickly reduced anxiety-related brain activity, providing fast relief from anxiety symptoms in stressful situations. This indicates the treatment can work quickly and effectively for managing anxiety.
Another study examined DBS for a different condition and found that, after a year, many patients experienced a significant reduction in their symptoms, with many responding well to the treatment. These findings highlight the potential safety and effectiveness of DBS.
While DBS involves some risks due to its surgical nature, evidence suggests it can be a safe option for those who need it. Discussing any concerns with a healthcare provider is always important before considering participation in a trial.12345Why are researchers excited about this trial?
Researchers are excited about Deep Brain Stimulation (DBS) for anxiety disorders because it offers a novel approach compared to standard treatments like medication and therapy. Unlike traditional treatments that often target chemical imbalances in the brain, DBS involves the direct application of electrical impulses to specific brain areas, potentially offering more precise control over anxiety symptoms. This technique may provide faster relief and benefit those who haven't responded well to medication or therapy. Additionally, the use of simultaneous intracranial EEG recordings during stimulation could help researchers better understand brain activity related to anxiety, leading to further treatment innovations.
What evidence suggests that this VR fear conditioning method is effective for anxiety disorders?
Research shows that brain stimulation treatments can effectively address anxiety disorders. These therapies have also helped conditions like OCD and PTSD. For instance, some studies found that brain stimulation led to significant improvements, with effect sizes ranging from 0.68 to 1.8. In this trial, all participants will undergo a form of deep brain stimulation (DBS) targeting specific brain areas, which has shown promise in improving treatment for anxiety and trauma-related disorders. While more research is needed for anxiety, these early results are encouraging.14678
Are You a Good Fit for This Trial?
This trial is for individuals with PTSD, particularly veterans, who already have a Responsive Neurostimulator (RNS) device implanted for epilepsy. They'll participate in VR sessions to study fear responses.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Experimental Sessions
Participants wear a VR headset, experience different environments and sounds, have brain activity, heart rate, and sweating measured, and receive mild electrical pulses through the RNS device.
Follow-up
Participants are monitored for safety and effectiveness after the experimental sessions
What Are the Treatments Tested in This Trial?
Interventions
- K08 VR Fear Conditioning
Trial Overview
The trial tests how VR environments affect fear learning by measuring brain activity and body responses like heart rate and sweating. Participants will receive mild electrical pulses through their RNS device.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
In this single-arm study, all participants will complete identical experimental conditions with simultaneous iEEG recordings (Recording Study) or iEEG stimulation (Stimulation Study).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
Duke University
Collaborator
VA Greater Los Angeles Healthcare System
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Citations
Efficacy and acceptability of brain stimulation for anxiety ...
The study results suggest that BSTs are effective treatments for anxiety disorders, OCD and PTSD; lf-rTMS may be considered as the most promising option.
Efficacy and acceptability of brain stimulation for anxiety ...
The study results suggest that BSTs are effective treatments for anxiety disorders, OCD and PTSD; lf-rTMS may be considered as the most promising option.
Predictors of short-term anxiety outcome in subthalamic ...
In the overall cohort, 33.1% of patients reported to have anxiety at baseline according to the established HADS-A cut-off. This is consistent ...
Efficacy of brain stimulation therapies across psychiatric, ...
In rTMS studies for anxiety disorders, significant SMDs ranged from 0.68 to 1.8. There were no notable differences in adverse events or dropout rates. For ...
Hypothalamic deep brain stimulation as a strategy to ...
In conclusion, our data suggest that brief hypothalamic DBS could be a useful strategy to augment treatment for anxiety- and trauma-related disorders to help to ...
Deep brain stimulation: current challenges and future directions
This Review considers how DBS has facilitated advances in our understanding of how circuit malfunction can lead to brain disorders and outlines the key unmet ...
The safety profile of subthalamic nucleus and globus ...
This study investigates the surgical and psychological complications associated with DBS surgery for movement disorders, aiming to quantify patient risk.
A prospective international multi-center study on safety and ...
After 12 months of stimulation, the mean Y-BOCS score was decreased by 42%, and 60% of the patients could be considered responders. Comorbid ...
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