Deep Brain Stimulation for Obsessive-Compulsive Disorder

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called deep brain stimulation (DBS) for individuals with severe obsessive-compulsive disorder (OCD) that hasn't improved with other treatments. The DBS device sends electrical impulses to specific brain areas to help reduce OCD symptoms. Candidates may qualify if they have experienced disabling OCD for over five years and have tried various medications and behavior therapies without success. As an unphased trial, this study provides an opportunity to explore an innovative treatment option for those who have not found relief through conventional methods.

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.

What prior data suggests that this deep brain stimulation is safe for treating OCD?

Research has shown that deep brain stimulation (DBS) using Medtronic Percept devices is generally well-tolerated by people with obsessive-compulsive disorder (OCD). About two-thirds of patients experienced a significant reduction in OCD symptoms at various intervals, such as 6 months and 12 months after starting treatment. This suggests the treatment is effective for many individuals.

The FDA has approved the Medtronic Percept DBS device for treating OCD, indicating it is considered safe for this use. However, like any medical treatment, there are risks. Some patients might experience side effects, but these are usually manageable. It is important to consult healthcare professionals to understand the possible risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Medtronic Percept Deep Brain Stimulation (DBS) for obsessive-compulsive disorder (OCD) because it offers a novel approach that targets brain regions in a way that current treatments don't. While traditional OCD treatments like cognitive-behavioral therapy and medications focus on altering behavior and brain chemistry, this DBS method directly stimulates specific brain areas—the dorsolateral prefrontal cortex and the ventral anterior limb of the internal capsule—using electrical impulses. This targeted stimulation could provide relief for patients with severe, treatment-resistant OCD, who don't respond to existing therapies, offering a new hope for more effective management of their symptoms.

What evidence suggests that Medtronic PC+S and Percept Deep Brain Stimulation might be effective treatments for OCD?

Research has shown that deep brain stimulation (DBS) can significantly help people with obsessive-compulsive disorder (OCD). Studies indicate that DBS may reduce OCD symptoms by 40-60% in about half of the patients. In this trial, participants will receive the Medtronic Percept system, which uses DBS and has approval for OCD in certain cases, offering hope for those with severe OCD unresponsive to other treatments. This treatment sends electrical signals to specific brain areas involved in OCD. These encouraging results suggest that DBS could be a valuable option for those who haven't found relief through other treatments. ^{2 5 6 7 8}

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

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

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

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

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]

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]

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]

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]

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 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 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]

Citations

1. medtronic.com medtronic.com/en-us/healthcare-professionals/specialties/neurology/therapies-procedures/deep-brain-stimulation/conditions/obsessive-compulsive-disorder.html

Obsessive-Compulsive Disorder - Deep brain stimulation Learn about the results deep brain stimulation may provide to some patients who have obsessive-compulsive disorder.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11299490/

Neural signal data collection and analysis of Percept™ PC ... Deep brain stimulation (DBS) using Medtronic's Percept™ PC implantable pulse generator is FDA-approved for treating Parkinson's disease (PD), essential ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06660225?term=AREA%5BConditionSearch%5D(Obsessive-Compulsive%20Disorder)%20AND%20AREA%5BBasicSearch%5D(deep%20brain%20stimulation)&rank=3

Deep Brain Stimulation for Refractory Obsessive ... The goal of this clinical trial is to learn if deep brain stimulation (DBS) works to treat refractory obsessive-compulsive disorder (OCD).

4. medtronic.com medtronic.com/content/dam/medtronic-wide/public/united-states/products/neurological/dbs-percept-rc-hcp-brochure.pdf

Percept™ family with BrainSense™ technology Medtronic DBS therapy is approved for five indications: Parkinson's disease, essential tremor, dystonia*, obsessive-compulsive disorder* (OCD), and epilepsy.

5. withpower.com withpower.com/trial/phase-compulsive-personality-disorder-9-2016-da649

Deep Brain Stimulation for Obsessive-Compulsive Disorder Studies suggest that DBS can reduce OCD symptoms by 40-60% in about half of the patients, although it is still considered experimental. Show more ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05915741

Study Details | NCT05915741 | Brain Recordings in ... In this project, the investigators will recruit patients treated with DBS for OCD under the standard clinical (HDE) pathway. The FDA/HDE-approved device for ...

7. pacificneuroscienceinstitute.org pacificneuroscienceinstitute.org/movement-disorders/wp-content/uploads/sites/7/2020/12/US-Percept-Media-Kit-US-FY21-FINAL.pdf

MEDTRONIC PERCEPT™ PC NEUROSTIMULATOR ... Warning For Obsessive-Compulsive Disorder: Electroconvulsive Therapy (ECT) – The safety of ECT in patients who have an implanted deep brain stimulation (DBS) ...

8. medtronic.com medtronic.com/se-sv/healthcare-professionals/therapies-procedures/neurological/deep-brain-stimulation/clinical-outcomes/safety-probable-benefit-ocd.html

SAFETY and PROBABLE BENEFIT: OCD DEEP BRAIN ... Approximately two-thirds of the patients met the accepted criterion for a clinical response (25% reduction in YBOCS) at 6 months, 12 months, and last follow-up, ...