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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Magnetic stimulus intensity of 80% of the motor threshold applied at the frequency of 20 Hz over the left DLPFC with a total number of pulses of 1200 / treatment session for a total of 5 sessions /week for 3 consecutive weeks |
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| Sham | Placebo Comparator | Sham procedure implies the use of a "sham" coil of exactly the same dimension and appearance as the one used for the effective treatment. This sham coil is made for research purposes by the producing company and used in accordance with the instructions for use, which explicitly mention it (cf. instruction manual page 34: Stimulation Coil DuoMAG 70BFP (70BFP1, 70BFP2), typical use for blinded studies). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cornell Scale for Depression in Dementia (CSDD) | Mood assessment tool | from baseline to day 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment (MOCA) | Cognitive assessment tool | from baseline to day 20 |
| NPI-Q | Behavioural assessment tool for demented patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Armin von Gunten, MD | Centre Hospitalier Universitaire Vaudois | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Supaa - Chuv | Prilly | Canton of Vaud | 1008 | Switzerland |
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| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| from baseline to day 20 |
| The ratio of patients who completed the study and drop-outs due to non-compliance | Compliance assessment tool | 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. | from baseline to day 20 |