Benefits and Risks – DBS Therapy

CE marked, Reclaim® DBS Therapy for OCD is available for use as an adjunct to medication and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs).

Benefits

Reclaim DBS Therapy for OCD may help manage your symptoms, but it is not a cure. When your DBS System is turned on, it will deliver stimulation that may decrease your OCD symptoms. If stimulation is discontinued, symptoms will likely return.

• Non-destructive – Reclaim DBS is not intended to destroy nerve cells or healthy tissue in the way that lesioning surgery does.
• Reversible – Deep brain stimulation is reversible. If the therapy is not effective, it can be stopped and the system can be removed.
• Adjustable – Your clinician uses a special computer to wirelessly adjust the levels of stimulation. It may take several months to find the exact level of stimulation that is right for you.

Risks

Risks of Reclaim DBS Therapy can include risks of brain surgery, stimulation side effects, or device complications.

Your doctor can provide more information about these and other potential risks and side effects. Many side effects related to stimulation can be managed by adjusting the stimulation settings. Several follow-up visits may be needed to find the best stimulation settings.

Additionally, neurostimulator batteries will need to be replaced after a period of months or years, depending on the level of stimulation you require. The battery can be replaced in a surgical procedure that does not require an overnight stay in the hospital.

Risks of surgery may include:

• Paralysis, coma, and/or death
• Bleeding inside the brain (intracranial hemorrhage)
• Leakage of fluid surrounding the brain
• Seizures
• Infection
• Allergic response to implanted materials
• Temporary or permanent neurological complications
• Confusion or attention problems
• Pain at the surgery sites
• Headache

Side Effects

Possible side effects of brain stimulation may include:

• Suicidal ideation and depression
• Increased OCD symptoms
• Changes in mood (positive and negative)
• Increased anxiety
• Gastrointestinal disturbances
• Sensations such as tingling (paresthesia), smell, or taste
• Dizziness or lightheadedness (disequilibrium)
• Facial and limb muscle weakness or partial paralysis (paresis)
• Facial flushing or facial muscle contractions
• Jolting or shocking sensation
• Numbness (hypoesthesia)
• Increased heart rate
• Hyperactivity or euphoria (hypomania)

Your doctor should carefully monitor you for symptoms of depression, anxiety, and/or hypomania/mania. Such symptoms may include changes in sleep or eating behavior, disinhibition, anger, aggression, and a predisposition to accidents.

There is also potential for brain tissue damage if the stimulation parameters are set too high. Your physician will be warned when the stimulation parameters exceed a certain charge density.

Device Complications

Possible device complications include:

• Pain, lack of healing, or infection where the brain stimulation system parts are implanted
• Infection or scarring caused by the stimulation system parts wearing through your skin
• Readjustment surgery if the lead or lead/extension connector moves, or if mechanical or electrical problems occur
• An allergic reaction to or rejection of the brain stimulation system by your body
• Tissue damage resulting from programming parameters or a malfunction of one of the parts of the brain stimulation system

Section Navigation

• About DBS Therapy
• What Is It?
• Benefits and Risks
• Questions and Answers

Additional information