Lexical semantic disorders are described in Alzheimer's disease, and their incidence in everyday life is important to the extent that these disorders affect expression and comprehension. Providing a tactile tablet stimulation, independent and complementary to speech therapy, could help to maintain certain abilities and reinforce the feeling of autonomy of the patients.
It is a monocentric, controlled, randomized, parallel-group, single-blind clinical trial. For each of the two forms of Alzheimer's Disease (young or late), it compares two groups of patients: a group benefiting from a tactile tablet semantic stimulation (tablet group) and a control group All patients benefit from a clinical evaluation and a language assessment at M0, M3 and M6. The analyzes will be conducted in intention to treat. The main criterion is the 3-month variation of the Lexis 3 subtests scores. The two groups will be compared by the Student test. The number of subjects required is based on the following assumptions: a 10% increase over three months of the Lexis subtests scores in the tablet group and a stability of the scores in the control group. The standard deviation of the variation is assumed to be identical in both groups and equal to 13% at the most. Three scores being compared, tests will be conducted at the 1.67% threshold (Bonferroni correction) to ensure a 5% overall risk of first species. The inclusion of 36 patients in each of the two treatment groups will give 80% power to the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1
stimulation of the lexico semantic system on a tactile tablet therapy for 3 months
speech therapy
Hôpital Pitié-Salpêtriere
Paris, France
APHP - Pitié-Salpêtrière Hospital
Paris, France
variation of performance on naming subtest of the LEXIS
Time frame: variation from baseline at 3 month
variation of performance on designation subtest of the LEXIS
Time frame: variation from baseline at 3 month
variation of performance on semantic matching subtest of the LEXIS
Time frame: variation from baseline at 3 month
variation of performance on DO80 lexico-semantic test
Time frame: variation from baseline at 3 month and 6 month
variation of performance on verbal fluency lexico-semantic test
Time frame: variation from baseline at 3 month and 6 month
variation of performance on verbal discrimination of BADAE
Time frame: variation from baseline at 3 month and 6 month
variation of performance on episodic memory test (RL/RI)
Time frame: variation from baseline at 3 month and 6 month
variation of performance on Mini-Mental State Examination (MMSE)
Time frame: variation from baseline at 3 month and 6 month
variation of score on depression scale (HAD)
Time frame: variation from baseline at 3 month and 6 month
variations on care giver's questionary
Time frame: variation from baseline at 3 month and 6 month
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variation of performance on naming subtest of the LEXIS
Time frame: variation from 3 month at 6 month
variation of performance on designation subtest of the LEXIS
Time frame: variation from 3 month at 6 month
variation of performance on semantic matching subtest of the LEXIS
Time frame: variation from 3 month at 6 month