This is a monocentric prospective, randomized, double-blind placebo-controlled study. It is designed to evaluate the superiority of the rTMS over sham treatment of depressive symptoms in the context of dementia. It is aimed at a population ≥ 65 years old, with affective BPSD. We wish to recruit 44 participants, with an estimated rate of potential drop out of 20%. Patients will be randomly assigned to the sham or rTMS group. The sham stimulation reproduces the procedure in all the steps, has the same duration and differs exclusively by the device setting. After inclusion, both groups will receive 15 sessions distributed over 5 days a week for 3 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
The stimulus intensity will be 80% of the motor threshold and the frequency will be 20 Hz for all patients. The total number of pulses will be 1200 for a single treatment session. We plan a total of 15 sessions distributed over 5 days a week for 3 consecutive weeks.
Supaa - Chuv
Prilly, Canton of Vaud, Switzerland
Cornell Scale for Depression in Dementia (CSDD)
Mood assessment tool
Time frame: from baseline to day 20
Montreal Cognitive Assessment (MOCA)
Cognitive assessment tool
Time frame: from baseline to day 20
NPI-Q
Behavioural assessment tool for demented patients
Time frame: from baseline to day 20
The ratio of patients who completed the study and drop-outs due to non-compliance
Compliance assessment tool
Time frame: During all the study period
Possible changes of structural MRI before as compared to after the treatment
quantitative structural MRI protocol allowing for an optimal segmentation - resolution of grey versus white matter including cortical and sub-cortical brain structures.
Time frame: from baseline to day 20
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