What is the mechanism of action of this treatment?

The most common treatments for Obsessive-Compulsive Disorder (OCD) include pharmacological therapies like selective serotonin reuptake inhibitors (SSRIs) and neuromodulation therapies such as Deep Brain Stimulation (DBS). SSRIs work by increasing serotonin levels in the brain, which helps alleviate OCD symptoms. DBS involves the implantation of electrodes that deliver electrical impulses to specific brain areas to regulate abnormal activity. This is crucial for patients with treatment-resistant OCD, providing an alternative when conventional treatments are ineffective.

What side effects are associated with this type of intervention?

Deep Brain Stimulation (DBS) for Obsessive-Compulsive Disorder (OCD) can lead to side effects such as infection, bleeding, and hardware complications. Transient side effects may include impulsivity, sleeping problems, and tension, which can often be managed by adjusting the stimulation parameters. Other neuromodulation therapies like repetitive transcranial magnetic stimulation (TMS) may cause headaches, scalp discomfort, and, rarely, seizures. These side effects are generally mild and temporary.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for OCD, including selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, sertraline, and clomipramine. In terms of neuromodulation treatments similar to the Medtronic PC+S Deep Brain Stimulation (DBS), the FDA has approved DBS for severe, treatment-resistant OCD. This involves the use of electrical impulses to regulate abnormal brain activity, providing an option for patients who do not respond to conventional therapies.

What other types of research exist?

Promising novel alternatives to Medtronic PC+S Deep Brain Stimulation for OCD patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in reducing depressive relapses and is being explored for maintenance treatment in bipolar depression. 2) Transcranial Direct Current Stimulation (tDCS), a noninvasive approach delivering low-intensity direct current to specific cortical regions, which has shown potential in enhancing neurocognition and treating depression. Both methods are less invasive compared to DBS and have shown promising results in clinical studies.

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Deep Brain Stimulation

Deep Brain Stimulation for Obsessive-Compulsive Disorder

N/A

Waitlist Available

Led By Darin D Dougherty, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 21 and 65 years

Be older than 18 years old

Must not have

Pregnancy and women of childbearing age not using effective contraception

Any current clinically significant neurological disorder or medical illness affecting brain function, other than tic disorders or Tourette syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

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).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, headache following surgery or stimulation adjustments; risk of infection; possible changes in mood or behavior; and rarely bleeding inside the brain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have any brain-affecting illnesses except for tic disorders or Tourette syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Yale-Brown Obsessive-Compulsive Scale (YBOCS)

Secondary study objectives

Clinical Global Impressions (CGI) Severity and Change scale

Montgomery-Asberg Depression Rating Scale (MADRS)

Patient Global Impressions (PGI) scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Medtronic Percept Deep Brain StimulationExperimental Treatment1 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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Obsessive-Compulsive Disorder (OCD) include pharmacological therapies like selective serotonin reuptake inhibitors (SSRIs) and neuromodulation therapies such as Deep Brain Stimulation (DBS). SSRIs work by increasing serotonin levels in the brain, which helps alleviate OCD symptoms. DBS involves the implantation of electrodes that deliver electrical impulses to specific brain areas to regulate abnormal activity. This is crucial for patients with treatment-resistant OCD, providing an alternative when conventional treatments are ineffective.