Deep Brain Stimulation for Anxiety Disorders

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Traumatic brain injury

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

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. ^{1 2 3 4 5}

Why 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. ^{1 4 6 7 8}

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

I am male.

I am female.

I am between 18 and 70 years old.

Exclusion Criteria

History of traumatic brain injury

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

1-2 sessions, each lasting 3-4 hours

Follow-up

Participants are monitored for safety and effectiveness after the experimental sessions

4 weeks

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?

Group I: All RNS Participants Experimental Treatment 1 Intervention

In this single-arm study, all participants will complete identical experimental conditions with simultaneous iEEG recordings (Recording Study) or iEEG stimulation (Stimulation Study).

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

VA Greater Los Angeles Healthcare System

Collaborator

Trials

53

Recruited

8,700+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39477076/

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.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032724017683

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.

3. nature.com nature.com/articles/s41531-024-00701-6

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 ...

4. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00625-4/fulltext

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 ...

5. pnas.org pnas.org/doi/10.1073/pnas.2113518119

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6397644/

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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12006204/

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.

8. nature.com nature.com/articles/s41380-019-0562-6

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 ...