Alzheimer Disease Clinical Trial
Official title:
Cognitive, Behavioral and Functional Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Potential Alzheimer Disease: Two Treatment Modalities Comparison
Randomized clinical trial, comparative and single blind aims to determine effects on cognition, psychological and behavioral symptoms and functionality of 5 Hz repetitive transcranial magnetic stimulation (rTMS) administered over left dorsolateral prefrontal cortex (lDLPFC) compared to six regions protocol, divided in two sub-conditions: day 1 (Broca area, Wernicke area and lDLPFC) alternated by day 2 (left and right parietal association cortex, and right dorsolateral prefrontal cortex [rDLPFC]). Main outcomes will be evaluated at ending of 15 rTMS sessions and 4 weeks after.
Alzheimer disease (AD) is a neurodegenerative disorder characterized by progressive cognitive
decline that affects behavior and daily functionality. Its etiology is unknown and treatment
efficacy is partial. Repetitive transcranial magnetic stimulation has been suggested as a
potential treatment as of several trials has revealed improvements in language, episodic
memory, psychological and behavioral symptoms in dementia as well as functionality using
different experimental designs, stimulation parameters and cortical targets comparisons.
However, it remains to determine the most effective modality, comparing outcomes with
cortical targets poorly studied and how much the effects last. The main objective of this
study is to determine which of two stimulation modalities provides a better cognitive and
behavioral effect also on functionality in patients with potential diagnosis of AD,
administered over lDLPFC (Condition A) and a six areas condition (Condition B) in which are
alternated two sub-conditions (Day 1: Broca and Wernicke areas and lDLPFC, and Day 2:
bilateral parietal association cortex and rDLPFC) along 15 sessions and 1500 pulses per
session.
For this purpose, will be randomized 22 patients with potential diagnosis of AD (according to
DSM-5) to both stimulation conditions (11 patients to each condition). The rTMS will be
administered at 5 Hz and 1500 pulses per session (30 trains and 10 seconds inter-train
interval) along 15 sessions with a post-treatment evaluation at 4 weeks comparing: time
response, post-treatment effects and 4 weeks effects.
To evaluate clinical response among stimulation conditions will be used Alzheimer´s Disease
Assessment Scale COGNITIVE (ADAS-cog), Cumming's Neuropsychiatric Inventory (NPI), Yesavage
Geriatric Depression Scale (GDS), Interview for Deterioration-in-daily Living Activities in
Dementia (IDDD) and Clinical Global Impression (CGI). The modified version of Mini Mental
State (MMSE-FOLSTEIN) will be applied in the same time points of other evaluations also at
the session 5 and 10. Other interest variables are: age, sex, civil status, education,
occupation, time and type of pharmacological treatment.
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