Deep Brain Stimulation for Obsessive-Compulsive Disorder

Recruiting at 1 trial location

Overseen By Darin D Dougherty, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Serotonin inhibitors

Disqualifiers: Psychotic disorder, Bipolar, Neurological disorder, Substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

2 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses a device that sends electrical signals to the brain to help patients with severe OCD who haven't responded to other treatments. It works by correcting abnormal brain activity and also records data to help researchers understand the treatment better. Deep brain stimulation (DBS) is an innovative treatment for severe obsessive-compulsive disorder (OCD).

Will I have to stop taking my current medications?

The trial requires that you either be drug-free or on a stable medication regimen for at least 6 weeks before participating. This means you may need to stop or adjust your current medications to meet this requirement.

Is deep brain stimulation safe for treating obsessive-compulsive disorder?

Deep brain stimulation (DBS) for obsessive-compulsive disorder (OCD) has been studied and is generally considered safe, with most side effects being mild or moderate and temporary. Serious side effects can occur but are often related to the programming of the device and can be adjusted. Overall, the potential benefits of DBS for treatment-resistant OCD may outweigh the risks. ^{1 2 3 4 5}

How is deep brain stimulation different from other treatments for obsessive-compulsive disorder?

Deep brain stimulation (DBS) for obsessive-compulsive disorder (OCD) is unique because it involves implanting electrodes in the brain to send electrical impulses, which can be adjusted after surgery to optimize treatment. This approach is reversible and can lead to significant symptom reduction in patients who have not responded to other treatments, although it is still considered experimental. ^{1 6 7 8 9}

What data supports the effectiveness of this treatment for obsessive-compulsive disorder?

Deep brain stimulation (DBS) has shown promising results for people with severe obsessive-compulsive disorder (OCD) who haven't responded to other treatments. Studies suggest that DBS can reduce OCD symptoms by 40-60% in about half of the patients, although it is still considered experimental. ^{1 6 10 11 12}

Who Is on the Research Team?

Darin Dougherty, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

Adults aged 21-65 with severe OCD, not improved after multiple treatments including drugs and behavioral therapy, can join this trial. They must be in good health, understand the study, consent to it, have a supportive family member or friend, and live near the study site. Excluded are those with psychotic disorders, low IQ/cognitive impairments affecting consent ability, bipolar disorder history, MRI contraindications like metal implants or claustrophobia.

Inclusion Criteria

I am in good health overall.

Patient is aware of, able to adhere to, and willing to tolerate the frequency of visits associated with adjustment of the dual-stimulation configuration and/or collection of brain recordings. This will usually mean limitation to patients who live close to the study site

Platelet count greater than 125,000 per cubic millimeter and a PT and PTT within normal limits

Exclusion Criteria

Full-scale IQ below 75 on the Wechsler Abbreviated Scale of Intelligence (WAIS) or cognitive impairment that would affect a participant's ability to give informed consent or provide interview or self-report data reliably, as determined by the consent monitor and the site psychiatrist

I am not pregnant and if of childbearing age, I use effective contraception.

Imminent risk of suicide or an inability to control suicide attempts (in the investigators' judgment)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive deep brain stimulation in the dlPFC and VC/VS regions using the Medtronic Percept DBS system

2 years

Regular clinical visits for outcome measure collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Medtronic PC+S Deep Brain Stimulation
• Medtronic Percept Deep Brain Stimulation

Trial Overview The Medtronic PC+S deep brain stimulation device is being tested as a treatment for patients with intractable OCD. This involves surgical implantation of electrodes into specific brain areas to modulate activity through electrical impulses.

How Is the Trial Designed?

Group I: Medtronic Percept Deep Brain Stimulation Experimental Treatment 1 Intervention

Single open label arm. Patients with severe, treatment-refractory obsessive-compulsive disorder (OCD) will receive stimulation in two separate, but related, brain regions, the dorsolateral prefrontal cortex (dlPFC) and the ventral anterior limb of the internal capsule and adjacent ventral striatum (VC/VS) with a novel Medtronic Percept deep brain stimulation (DBS) system.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

In a pilot study involving six patients with severe, treatment-resistant OCD, 66.7% showed significant improvement after 12 months of deep brain stimulation (DBS) targeting the ventral capsule/ventral striatum, indicating its potential as a last-resort therapy.

The study reported that while DBS led to improvements in OCD symptoms and global functioning, some patients experienced mild adverse effects, and stimulation interruption could quickly induce depressive symptoms, highlighting the need for careful patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for intractable obsessive compulsive disorder: pilot study using a blinded, staggered-onset design. Goodman, WK., Foote, KD., Greenberg, BD., et al.[2022]

Deep brain stimulation (DBS) in the bed nucleus of stria terminalis (BNST) showed a significant response in 60% of the 10 patients with severe, treatment-resistant OCD, with an average symptom reduction of 53% as measured by the YBOCS scale.

The treatment not only reduced OCD symptoms but also improved depressive symptoms, global functioning, and quality of life, indicating that DBS could be a promising option for patients who do not respond to standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for treatment resistant obsessive compulsive disorder; an observational study with ten patients under real-life conditions. Abdelnaim, MA., Lang-Hambauer, V., Hebel, T., et al.[2023]

Deep brain stimulation (DBS) in four women with treatment-resistant OCD showed a 19% improvement in obsessive-compulsive symptoms and anxiety after one year, indicating its potential efficacy as a treatment option.

While two patients experienced significant improvements, there were also adverse events, including the emergence of suicidal ideation in two patients, highlighting the need for careful monitoring and consideration of risks associated with DBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychopathological and neuropsychological outcomes of deep brain stimulation for severe- treatment-resistant obsessive-compulsive disorder: An open-label case series. Parvaresh-Rizi, M., Ghadirivasfi, M., Babaei, S., et al.[2022]

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) can lead to significant psychiatric side effects, particularly when electrodes are implanted in the subthalamic nucleus, which is associated with increased risks of depression and suicidal thoughts.

Higher voltage settings during DBS are linked to more severe depressive symptoms, highlighting the need for careful management of stimulation parameters to minimize adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulation-induced side effects after deep brain stimulation - a systematic review. Zarzycki, MZ., Domitrz, I.[2022]

Deep brain stimulation (DBS) of the ventral anterior limb of the internal capsule significantly improved symptoms of obsessive-compulsive disorder (OCD) and depression in five patients with treatment-refractory OCD and comorbid bipolar disorder, with notable reductions in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and Hamilton Depression Rating Scale (HAM-D) scores over a follow-up period of 15 to 68 months.

While transient hypomanic symptoms occurred in 4 out of 5 patients, these symptoms were manageable and did not lead to serious adverse effects, suggesting that bipolar disorder should not be an absolute contraindication for DBS in OCD patients, although careful monitoring is essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is deep brain stimulation effective and safe for patients with obsessive compulsive disorder and comorbid bipolar disorder? Graat, I., van Rooijen, G., Mocking, R., et al.[2021]

In a study of 21 patients with severe OCD or MDD undergoing deep brain stimulation (DBS) in the ventral striatum, no significant cognitive declines were observed after an average of 8.91 months of stimulation.

Patients showed significant improvements in verbal memory, suggesting that DBS may enhance cognitive functions without negatively impacting overall mental health, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychological outcome after deep brain stimulation in the ventral capsule/ventral striatum for highly refractory obsessive-compulsive disorder or major depression. Kubu, CS., Malone, DA., Chelune, G., et al.[2013]

In a study of 70 patients receiving deep brain stimulation (DBS) for treatment-refractory OCD, insight into the illness was the only significant predictor of treatment response, with an 84.4% positive predictive value.

Demographic factors like late-onset OCD and comorbid personality disorders influenced symptom changes but were not reliable enough to predict DBS outcomes, suggesting that clinical characteristics should not be used to exclude patients from this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting Response to vALIC Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder. Graat, I., Mocking, RJT., de Koning, P., et al.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for intractable obsessive compulsive disorder: pilot study using a blinded, staggered-onset design. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Deep brain stimulation in obsessive-compulsive disorder. [2009]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for treatment resistant obsessive compulsive disorder; an observational study with ten patients under real-life conditions. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for treatment-refractory obsessive compulsive disorder: a systematic review. [2023]

5. Scotland pubmed.ncbi.nlm.nih.gov

Psychopathological and neuropsychological outcomes of deep brain stimulation for severe- treatment-resistant obsessive-compulsive disorder: An open-label case series. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder. [2022]

7. Sweden pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation for psychiatric disorders]. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Stimulation-induced side effects after deep brain stimulation - a systematic review. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Is deep brain stimulation effective and safe for patients with obsessive compulsive disorder and comorbid bipolar disorder? [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Neuropsychological outcome after deep brain stimulation in the ventral capsule/ventral striatum for highly refractory obsessive-compulsive disorder or major depression. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Predicting Response to vALIC Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Preliminary study in patients with obsessive-compulsive disorder treated with electrical stimulation in the inferior thalamic peduncle. [2019]