The project HELP focuses on the area of chronic diseases related to the elderly population, which exert an increasing impact in the present society due to the longer expectancy of life. Such is the case of Parkinson’s disease (PD), a pathology that is thought to affect more than 4 million people world-wide. It is the 4th most frequent disorder of the nervous system, after Epilepsy, brain vascular disease and Alzheimer. HELP will integrate a system to dynamically monitories and treat PD, composed of: 1.     A non-invasive intra-oral continuous anti-PD drug delivery device3; 2.     A pump to deliver on-demand rescue medication to the subcutaneous tissue in order to relieve blockade episodes; 3.     A PAN (Personal Area Network) to gather user's environment information to detect blockades; 4.     A telecommunication and services infrastructure to analyze and transfer information both from the user to an automated system (most of the times) or a point-of-care (for the regular follow-up and emergencies) and in the opposite direction; 5.     A remote point-of-care unit to supervise the patients.  Such a system will be able to administer drug therapy in a controlled and either continuous or on-demand basis, to control disease progression and to mitigate PD symptoms.

Progress beyond the state-of-the-art

Oral drug delivery: Ordinarily anti-PD medication delivery (i.e. swallowing pills at discrete times) results in fluctuating blood levels of the drug and its dosage cannot be controlled by a point-of-care. In addition, the regular intake of those drugs is entirely dependent upon patient adherence to the treatment. DA are absorbed efficiently only in the upper gastrointestinal (GI) tract, i.e. the stomach and the proximal section of the small intestine. However, the passage of the drugs from the stomach to the intestine is too fast, which limits the period allowed for absorption into the blood stream. Delivering drugs at a constant rate to the GI tract from an alternative dosage system will control the drug residence time at the optimal absorption site and lead to maintaining constant drug levels in blood and tissue.  Subcutaneous drug delivery: A basic requirement in medication delivery technologies is the ability to get the desired therapeutic effect as predictably as possible. So far, injection is the only medication delivery system that is optimally controlled, i.e., it is administered specifically to the targeted patient and in the desired dosage. This, however, is far from being "user friendly" and cannot be administered in a wide variety of settings. So, ideally an alternative system should be minimally invasive and easily worn and controlled. Relative to injections, subcutaneous pumps are the most convenient and common system.  Symptoms recognition and prevention: Parkinson's disease is characterized by severe movement disorders including bradykinesia, gait freezing, gait alterations, falls and others. Inertial sensors composed of accelerometers and gyroscopes have been found useful in detecting falls and studying the gait of Parkinson sufferers, as well as in analyzing their movements and activity. Within the scope of HELP project, the movements and activity of Parkinson patients will be monitored by an advanced inertial sensor. The so-collected information will allow the physicians to closely control PD's clinical manifestations and to accurately adjust the medication delivered by the intraoral device as well as by the subcutaneous pump. Furthermore, monitoring both the patient‟s movements and behavior patterns  Technological support: HELP will integrate accelerometers (used to monitor movement patterns in order to avoid blockades), mobile and home gateways (smart phones and media centers) with basic intelligence to take decisions of drug delivery and to register in a server all the information in a medically understandable way. ICT based tools (videoconferencing, outdoor/indoor location, semantic webs, multiplatform environment, etc.) will allow the medical staff to access the gathered information and the patient for regular consultations and management interfaces to drug delivering devices. The main challenge will be to integrate all this together and to make it commercially viable.  Medical innovation: As a result of PD, many patients tend to move slower and in turn, perform activities slower; this condition worsens with increasing severity of disease, thus leading to a reduced functioning both inside and outside home. The perpetuation of this condition leads to a global reduction of the quality of life of PD patients. HELP will offer many benefits/advantages for PD patients and the society, being the main outcome for PD patients to increase their independence in daily living activities, reducing hospital or extended care facility stay. Other benefits: 1.     Reduction of behavioral co-morbidity; this will also turn in a better control of the effect of polypharmacy (i.e. certain classes of psychotropic drugs such as anti-anxiety, antidepressant, and antipsychotic medications can cause the symptoms of Parkinson's to become worse, including cognitive changes); thus if a patient is well controlled for motor symptoms with lower incidence of behavioral symptoms and good quality of life probably he will use with less frequency psychotropic drugs. 2.     Improvement of sleep disturbances; falling asleep and staying asleep can be difficult for PD patients, especially in the hospital or extended care facility setting. Maintaining daytime hobbies will encourage the patient to maintain its home bedtime regimen with subsequent improvement of sleep hygiene. 3.     Reduction of falling; PD patients are prone to falling as a part of their baseline state due to postural instability. When they are in a state of being off or frozen, the chance of falling is multiplied. Due to a better motor control obtained with HELP, patients will be encouraged to practice exercise and walking with subsequent increased mobility and reduced risk of falling. 4.     Increased mobility, which will also lead to: 5.     Improvement of constipation – a frequent side-effect of PD drugs as well as of PD reduced mobility – and to: 6.     Improvement of nutrition. Maintaining an adequate nutritional intake can be difficult for some PD patients; indeed, they can have difficulty in physically getting the food to their mouths due to disabling hand tremors, stiffness, slowness, or dyskinesias. Meliorating emotional and social caregiver distress will be the result of all above mentioned benefits.