Adaptive Deep Brain Stimulation for Obsessive-Compulsive Disorder

Not currently recruiting at 2 trial locations

Overseen By Nithya Ramakrishnan, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must be taking: SSRIs, Antipsychotics

Disqualifiers: Psychotic disorders, Substance abuse, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to managing severe Obsessive-Compulsive Disorder (OCD) using adaptive Deep Brain Stimulation (aDBS). OCD can cause intrusive thoughts and repetitive behaviors that are difficult to control. The study aims to improve brain stimulation techniques to alleviate these symptoms. Participants will have a device implanted in their brains to determine if it better controls their OCD symptoms. Individuals who have struggled with OCD for over five years, tried various medications and therapies without success, and find their daily life disrupted by the disorder might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for those who have not found relief through traditional methods.

Will I have to stop taking my current medications?

The trial requires that participants have a stable psychotropic medication regimen for the month before surgery, so you may need to continue your current medications if they are stable. The protocol does not specify if you must stop any medications, but it seems you should maintain your current regimen.

What prior data suggests that this adaptive Deep Brain Stimulation system is safe for treating OCD?

Research shows that deep brain stimulation (DBS) can help reduce symptoms in people with severe OCD. Studies have found that it can decrease obsessive-compulsive symptoms by up to 42%, suggesting DBS might help balance brain activity in those with OCD.

DBS involves surgery to place small devices in the brain, which send electrical signals to help manage symptoms. Safety is crucial when considering any treatment. Past research indicates that patients generally tolerate DBS well, reporting improvements and no major side effects.

However, DBS remains an experimental treatment for OCD and is not yet standard practice. As DBS undergoes testing in this study, awareness of possible risks is important. Consulting a doctor can help potential participants understand the safety and potential effects of the treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Adaptive Deep Brain Stimulation (DBS) for Obsessive-Compulsive Disorder (OCD) because it offers a new way to personalize brain stimulation based on the patient's specific needs. Unlike standard treatments like cognitive-behavioral therapy or medications that target neurotransmitters, Adaptive DBS actively monitors brain activity and adjusts the stimulation in real-time. This could lead to more effective and precise management of OCD symptoms. Furthermore, the Summit RC+S DBS Implant allows for the surgical implantation of electrodes that can both stimulate and record brain activity, providing valuable insights into how OCD affects the brain and how it can be better treated.

What evidence suggests that adaptive Deep Brain Stimulation is effective for OCD?

Research has shown that Deep Brain Stimulation (DBS) could be a promising treatment for severe Obsessive-Compulsive Disorder (OCD). In well-organized studies, about 66% of patients responded positively to DBS, often outperforming other treatments. Another study found that the success rate increased to 70.7% over time, indicating long-term benefits. This trial will examine Adaptive Deep Brain Stimulation, which involves placing small devices in the brain to help correct circuits related to OCD symptoms. Early results suggest this method could provide significant relief for those with severe OCD that doesn't improve with other treatments. ^{2 6 7 8}

Who Is on the Research Team?

Wayne K Goodman, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for adults aged 21-70 with severe OCD that hasn't improved after trying many treatments, including cognitive-behavioral therapy and various medications. Participants must have a history of at least five years of difficult-to-treat OCD and significant distress or impairment due to the disorder.

Inclusion Criteria

I have completed 25 hours of a specific therapy for OCD without success.

I have tried clomipramine for my condition but it didn't work or caused side effects.

I've tried and didn't respond to certain medications with added antipsychotics.

Exclusion Criteria

I am not pregnant and do not plan to become pregnant in the next 2 years.

You require the use of diathermy during the study.

You have been assessed by a doctor and they believe you are at high risk of acting impulsively or having thoughts of self-harm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

2 visits (in-person)

Treatment

Subjects undergo surgical implantation of RC+S DBS system with ECoG paddles and subsequent programming and monitoring

12 months

Multiple visits for surgery, programming, and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of mood and anxiety

6 months

Regular follow-up visits

Blinded Discontinuation Period

Subjects undergo a one-month blinded discontinuation period to assess the effects of DBS discontinuation

4 weeks

Weekly visits

What Are the Treatments Tested in This Trial?

Interventions

• Adaptive Deep Brain Stimulation

Trial Overview The study tests an adaptive Deep Brain Stimulation (aDBS) system using the Summit RC+S System with ECoG paddles in subjects with hard-to-control OCD. The goal is to improve brain targeting for DBS and find a more effective treatment method for OCD.

How Is the Trial Designed?

Group I: Summit RC+S DBS Implant for OCD Experimental Treatment 1 Intervention

All subjects will receive surgical implantation of RC+S DBS system with ECoG paddles

Group II: One Month Blinded Discontinuation Period Experimental Treatment 1 Intervention

The subject and Independent Evaluators are blinded to timing of discontinuation. In all cases, the sequence will be as follows in one-week segments: 100% Active, 50% Active, Sham and Sham. Subjects will be seen weekly. Amplitude will be reduced by 50% at start of week 2 and turned off at start of week 3. Subjects will be told that DBS will be discontinued at some point during the 4 weeks. The purpose of the 50% initial reduction is to minimize rebound effects. The programmer (not the PI in this case) will be open to the design and perform "sham" activation as described previously. Relapse is defined as a 25% increase of the Y-BOCS over two consecutive visits compared to discontinuation baseline

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Carnegie Mellon University

Collaborator

Trials

80

Recruited

540,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Brown University

Collaborator

Trials

480

Recruited

724,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

Deep brain stimulation (DBS) shows promise as a safe and effective treatment for patients with treatment-resistant obsessive-compulsive disorder (OCD), with average reductions in Yale-Brown Obsessive Compulsive Scale scores ranging from 6.8 to 31 points across small studies.

Approximately 50% of patients respond positively to DBS, and the frequency of adverse events appears to be limited, indicating that it could be a viable option for those who do not respond to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of deep brain stimulation for obsessive-compulsive disorder: a clinical review of different targets. de Koning, PP., Figee, M., van den Munckhof, P., et al.[2021]

In a study of 30 patients with severe, treatment-refractory OCD, deep brain stimulation (DBS) showed a 42% reduction in obsessive-compulsive symptoms after 12 months, with a responder rate of 60%.

While all patients experienced adverse events (195 total), most were mild or moderate, and the serious adverse events were primarily transient anxiety and worsening of affective symptoms, suggesting that the benefits of DBS may outweigh the risks in this challenging patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder. Menchón, JM., Real, E., Alonso, P., et al.[2022]

Deep brain stimulation (DBS) is being explored as a treatment for obsessive-compulsive disorder (OCD) in patients who have not responded to other therapies, with promising results from new targets like the medial forebrain bundle and habenula.

Current research is focusing on improving the precision of DBS targeting and exploring its combination with cognitive behavioral therapy (CBT), as well as assessing cost-effectiveness, which could enhance its clinical application for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation in the treatment of obsessive-compulsive disorder: current perspectives. Tastevin, M., Spatola, G., Régis, J., et al.[2020]

Deep brain stimulation (DBS) significantly reduces symptoms of obsessive-compulsive disorder (OCD) and depression, with mean score improvements of -15.0 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and -13.7 on the weighted depression scale at last follow-up, based on a review of 8 randomized controlled trials and 38 observational studies involving a total of 310 participants.

The study found no significant differences in efficacy between different target sites in the brain (limbic vs. non-limbic), and the overall safety profile showed a low rate of adverse events, with an average of 0.68 adverse events per treated patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, Effect on Mood Symptoms, and Safety of Deep Brain Stimulation in Refractory Obsessive-Compulsive Disorder: A Systematic Review and Meta-Analysis. Martinho, FP., Duarte, GS., Couto, FSD.[2020]

Deep brain stimulation (DBS) for treatment-resistant obsessive-compulsive disorder (OCD) has been associated with various adverse events, with psychiatric issues being the most common (40%), followed by neurological problems (19%) and infections (10%).

The study highlights that while DBS may be a viable treatment option for certain patients with refractory OCD, ongoing monitoring and further research are necessary to fully understand the long-term safety and efficacy of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for refractory obsessive-compulsive disorder: A review and analysis of the FDA MAUDE database. Porwal, MH., Karra, H., Sharma, U., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8474989/

Deep brain stimulation for obsessive-compulsive disorder The percentage of responders increased from 60.6% in the ST studies to 70.7% in the LT studies, indicating that DBS provided effective therapy for severe ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178122004619

Deep brain stimulation in obsessive-compulsive disorder The aim of this work is to investigate the effectiveness of Deep Brain Stimulation (DBS) in patients with severe Obsessive Compulsive Disorder (OCD)

3. jnnp.bmj.com jnnp.bmj.com/content/93/11/1166

Efficacy of deep brain stimulation for treatment-resistant ... Sixty-six per cent of patients in well-designed studies achieved response to DBS therapy, which compares with or outperforms recent estimates of treatment ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37984432/

Clinical outcomes of deep brain stimulation for obsessive ... Results: Six participants achieved clinical response (35% improvement in obsessions and compulsions on the Yale Brown Obsessive Compulsive Scale (YBOCS)) within ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7227118/

Improving long term patient outcomes from deep brain ... Deep brain stimulation (DBS) has emerged as an effective treatment for patients with severe treatment-refractory obsessive-compulsive disorder (OCD).

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03457675?tab=table

Development of Adaptive Deep Brain Stimulation for OCD ... In this study the investigators want develop an adaptive Deep Brain Stimulation (aDBS) system to use in subjects with intractable (hard to control) OCD. Deep ...

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

A prospective international multi-center study on safety and ... In conclusion, DBS for severe treatment-resistant OCD patients reduced the severity of obsessive-compulsive symptoms by an average of 40%, with ...

8. withpower.com withpower.com/trial/phase-compulsive-personality-disorder-6-2021-f00fa

Adaptive Deep Brain Stimulation for Obsessive ... In a study of 30 patients with severe, treatment-refractory OCD, deep brain stimulation (DBS) showed a 42% reduction in obsessive-compulsive symptoms after 12 ...