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Green light for brain device

24th February 2009

Regulators in the United States have approved the use of an implanted device that gives deep brain stimulation to patients with obsessive-compulsive disorder (OCD), and a trial is under way to see if it can treat severe depression.

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The Reclaim device, made by the Medtronic company, will be used to treat only the most severe and difficult cases of OCD.

The device bears resemblance to those now used to treat Parkinson's disease and other disorders affecting movement.

But the implantation is a potentially dangerous operation, with eleven members of the 26-large test group suffering adverse effects, and a risk of fatal cerebral hemorrhage and brain infection.

Therefore, the device will only be given to patients who have gone through multiple failed treatment attempts.

Neurosurgeon Hooman Azmi Azmi, who is familiar with the details of the clinical study testing the device, said that the Medtronic Reclaim is essentially like a pacemaker for the brain.

He said that wires bearing an implanted electrode run under the skin and attached to a generator that is also implanted in the body, and that doctors are given control over the electrical stimulation.

In its approval documentation, the Food and Drug Administration included a clause known as the "humanitarian device exemption" will permit the use of the device in only the most severely incapacitated.

Azmi said that only the most extreme cases are considered for treatment using the Reclaim device.

He said that they have lost all of what people would consider a normal life, have become unable to work, and cannot sustain any relationships.

In order to test the deep brain stimulation device, 26 such people at three medical centers in the US took part in a clinical study.

Eleven of the 26 patients suffered a total of 23 serious adverse events, which were all resolved without lasting damage.

Benjamin Greenberg said that deep brain stimulation is a promising treatment for a subset of patients with OCD who have remained ill and debilitated.

He said that such patients are beyond the help of the aggressive use of medications and cognitive behavioural therapy.

Azmi said that some of the patients in the study could go back to work, some could again have relationships, and more importantly, some of the patients could participate in behaviour therapy, which would play a role in their overall progress.

Each treatment case requires an interdisciplinary team to choose the right patients, implant the device, and to select the right electrical settings.

The progress of patients will also need to be supervised.

The Medtronic Reclaim stimulates a different part of the brain from other deep brain stimulation devices, and uses a special electrode developed for the treatment of OCD.

 

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