From the neuronavigator, to the innovative stimulator, to the directional leads, to the software for verifying the positioning of the electrodes.
The most advanced (and most precise) instruments have been used 'completely' for the first time in Italy at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS, for the Deep Brain Stimulation on a 52-year-old patient. The most avant-garde technological jewels for an ultra-precise, minimally invasive and patient-safe procedure.
A new milestone in the surgical treatment of Parkinson's has been reached at the Agostino Gemelli University Hospital Foundation. For the first time in Italy, Dr. Tommaso Tufo, a neurosurgeon at the Gemelli Polyclinic, implanted Percept PC™ with directional electrodes, the neurostimulator for Deep Brain Stimulation (DBS) therapy developed by Medtronic, using all the most advanced technologies currently available.
The surgery, carried out on a 52-year-old patient suffering from Parkinson's, represents a 'first' of its kind. For the first time, in fact, the latest Medtronic technologies have been exploited together: intraoperative imaging (O-arm), the Percept PC™ neurostimulator, with directional leads and, after implantation, the reconstruction of the positioning of the electrodes, with dedicated software.
"Deep Brain Stimulation (DBS) surgery - explains Dr. Tufo - is a technique that has long been validated (the first implant of this type carried out at Gemelli, which was also one of the first in Italy, dates back to 1996), which is indicated in movement disorders such as Parkinson's disease, essential tremor and dystonia, when medical therapy has not given optimal results or is burdened with important side effects.
This treatment is reserved for young patients, people under the age of 65, who respond little to medical therapy or who present disabling side effects from the same, such as on-off effects, motor fluctuations, blockages".
These interventions act on Parkinson's symptoms but do not cure it.
However, they allow to obtain a sort of 'rejuvenation' of the disease; for the patient, it is like going back to the early stages of his Parkinson's.
It's like being treated with an ideal 'H24' medication at a constant dosage.
The patient can expect an improvement in motor symptoms and it is possible to reduce drug therapy.
The response to this treatment also has good durability. "We have observed a good control of the symptoms of the disease - recalls Dr. Tufo - even in patients subjected to these implants twenty years ago, with neurostimulators certainly much less performing than those we use today".
DBS consists of the implantation of a neurostimulator, (a sort of pacemaker of the brain), composed of a generator that, like that of the cardiac pacemaker, is housed in a skin pocket under the collarbone, and a microelectrode that is placed at the level of the nuclei of the base, nerve structures that are located in the depths of the brain.
In order to realize this delicate implant in the brain, a very precise neurosurgical (stereotactic) technique is used.
"This technique in recent years has evolved - explains Dr. Tufo - thanks to the use of technologies and operating room instruments that allow you to be minimally invasive and ultra-precise. To 'centre' the implant area, it is used a 'neuronavigator' (a special operating room computer), which guides the neurosurgeon's hand on the cerebral 'roads', up to the nuclei of the base, following a sort of three-dimensional Google map, reconstructed starting from the images of the patient's brain MRI.
Thanks to the Intraoperative 3D Imaging system and the Medtronic Neuronavigator, the DBS procedure is performed with the fiducial-less technique, which avoids the use of the stereotactic helmet or bone screws, while ensuring maximum surgical precision and simplifying the flow of the procedure.
Computerized neuro-navigators are in turn connected to a kind of intraoperative CT scan ('O-arm') that allows you to check the position of the electrodes in real-time, directly in the operating room.
It is an important innovation; previously it was necessary, after the operation, to move the patient to radiology to carry out a post-operative control CT scan ".
After implanting the electrodes in the appropriate areas of the brain, the catheters that connect them to the pulse generator (a 'battery' of a few centimetres), housed in a subcutaneous pocket, under the collarbone, are passed subcutaneously.
Some of these generators are now rechargeable from the outside, can last up to 25 years and do not need to be replaced, as they once did.
The first DBS interventions were made in the early 90s; since then the technology has evolved very quickly, up to the current sophisticated systems.
"The electrodes used today – continues Dr. Tufo – are directional. They have various facets of stimulation, which allow directing the stimulation in a very precise way. Even the generators allow to carry out 'personalized' stimulations depending on the patient and the most advanced are able to read the brain activity (sensing), allowing to modulate the stimulation based on the patient's brain activity (so-called closed loop), thanks to dedicated software, which has just been released. All this also greatly reduces the risk of undesirable effects that are observed with classical stimulation (lowering of the timbre of the voice and effects on the production of language)".
"These new instruments, used for the first time all together here at the Gemelli University Hospital - underlines Professor Alessandro Olivi, director of the Gemelli Neurosurgery Unit, professor of Neurosurgery at the Catholic University - allow us to make this treatment more precise, effective and safe. It is the first time in Italy that the complete 'package' has been used, thanks to the commitment of the Gemelli Hospital Foundation which, responding to our request, wanted to invest in new technologies and personalized therapies".
Studies have shown that deep brain stimulation performed with the Medtronic DBS therapy system is effective in controlling essential tremor, dystonia and Parkinson's disease symptoms that are not adequately controlled by drug therapy. Medtronic DBS is also approved for the treatment of refractory epilepsy.
"The innovation of sensing – underlines Antonella Grassi, head of Medtronic's Neuromodulation division in Italy – represents an important contribution to the development of personalized therapies that can improve the quality of life for patients and in line with technological innovation. In addition, the accuracy of the measurements and the visualization programs connected to mobile devices and computers allow the doctor to verify in detail and with ease all the parameters he needs to set a tailor-made path ".
DBS therapy is currently approved in many countries around the world, including the United States and Europe, for the treatment of more or less recent-onset Parkinson's disease, essential tremor, primary dystonia, disabling symptoms of epilepsy and treatment-resistant obsessive-compulsive disorders.
Medtronic was the first company in the United States to offer full-body MRI conditional compatibility DBS systems to enable patients to undergo safe scans of any part of the body under certain conditions. Since 1987, more than 175,000 Medtronic DBS devices have been implanted worldwide for the treatment of motor disorders and other indications.