Alzheimer's Disease (AD) is characterized by the absence of treatments to slow, stop, or reverse its course, with patients finally losing cognitive functions, skills and independence. It is a chronic degenerative disease with high social and medical burden worldwide: AD ranked third among neurological disorders in terms of disability-adjusted life years (DALY) rates. The primary aim of the research protocol is to improve care for patients with AD, by implementing, with an innovative method, the currently available repertoire of neuromodulation techniques. For this aim, we will investigate whether Transcranial Pulse Stimulation (TPS) may induce cognitive improvement in patients with an early stage of dementia.
Aims of the project: The primary aim of our research protocol is to improve care for patients with AD by investigating whether Transcranial Pulse Stimulation (TPS) may induce cognitive improvement in patients with an early stage of dementia. Additional aims will include the investigation of the neurophysiological profile of patients and the search for a correlation between neuropsychological and neurophysiological data with the serum levels of brain-derived neurotrophic factor (BDNF) and of vascular endothelial growth factor (VEGF). Materials and Methods: Following a rigorous selection, included patients will be treated through a real/sham structured TPS protocol and followed-up with respect to cognitive improvement, by comparing baseline and follow-up clinical scores. A Double Blind Sham-Controlled Study will be performed: patients will be assigned randomly to receive TPS or sham TPS for 4 weeks in a parallel groups, double-blind study. Patients will receive ether TPS or sham treatment once a day for five days a week for the whole period and will be assessed according to the following schedule: baseline (t0); at two weeks following the start of TPS (t1); at 1 month following the start of TPS (t2); at 2 months following the start of TPS (t3); at 6 months following the start of TPS (t4). Electroencephalography (EEG) and Somatory Evoked Potentials (SEP) will be contextually recorded in all patients, to compare neurophysiological data of patients treated with real TPS and sham stimulation. Moreover, a serum sample will be collected from patients at baseline, at the end of the stimulation period and at the 6-month follow-up, to compare preprocedural and postprocedural levels of serum BDNF and VEGF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Patients will receive TPS once a day for five days a week, each session will be separated from the previous one by 24h. Each stimulation and assessment session will be performed at the same hour of the day, in the morning preferably, to maximize the probability of observing responses to stimuli. Patients will be managed in a quiete room with stable light and temperature.
San Salvatore Hospital
L’Aquila, Italy, Italy
RECRUITINGSan Salvatore Hospital
L’Aquila, Italy, Italy
RECRUITINGCognitive improvement
Cognitive improvement as evaluated by means of the ADAS-Cog, scores range from 0, that means the absence of cognitive dysfunctions, to a maximum of 70, that indicates a serious deficit in all tests.
Time frame: Two weeks following the start of TPS (t1); at 1 month following the start of TPS (t2); at 2 months following the start of TPS (t3); 6 months following the start of TPS (t4).
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