Risks and Probable Benefits – DBS Therapy

Indications: The Medtronic Reclaim DBS Therapy is indicated for bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive compulsive disorder (OCD) inadult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs).

Probable 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.

DBS Therapy requires brain surgery. Risks of brain surgery may include serious or even fatal complications such as coma, bleeding inside the brain, seizures, and infection. Once implanted, the system may become infected, parts may wear through your skin, and the lead or lead/extension connector may move. Medtronic DBS Therapy could stop suddenly because of mechanical or electrical problems. Any of these situations may require additional surgery or cause your symptoms to return.

Medtronic DBS Therapy may cause worsening of some symptoms associated with your obsessive-compulsive disorder, and may cause changes in mood. Stimulation parameters may be adjusted to minimise side effects and attain maximum symptom control. In patients receiving Medtronic DBS Therapy, depression, suicidal thoughts and suicide have been reported.

Your doctor should carefully monitor you for symptoms of depression, anxiety, and/or hypomania/mania. Such symptoms may include changes in sleep or eating behaviour, 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.

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