UnknownPhase 4

rTMS for the Treatment of Affective Symptoms in Patients Suffering From Dementia

Switzerland44 participantsStarted 2022-01-01

Plain-language summary

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

Who can participate

Age range65 Years

SexALL

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Inclusion Criteria: * Informed consent as documented by their and their proxy's signature (Appendix Informed Consent Form) * Consent for MRI * Age ≥ 65 years * Clinical dementia Rating Scale (CDR) ≥ 1 * NPI-Q Σ (\*Anxiety + \* Apathy/Indifference + \* Dysphoria/Depression) ≥ 3 * Cornell Scale for Depression in Dementia (CSDD) ≥ 10 Exclusion Criteria: * History of schizophrenia, bipolar disorder, schizoaffective disorder * History of macroscopic stroke. * Unstable somatic pathologies * Insufficient collaboration for the rTMS procedure * Drug freeness or drug adjustment as clinically required is not an exclusion criterion. * The proxy refuses to give consent in case of lack of capacity, or in any case where the participant expresses a wish not to participate/continue in the study. * Any contraindications to performing an MRI (cf CRF) and rTMS (aneurysm clips or coils, stents in the neck or brain, deep brain stimulators, electrodes to monitor brain activity, metal implants in the ears and eyes, facial tattoos with metallic or magnetically sensitive ink) procedure

What they're measuring

Cornell Scale for Depression in Dementia (CSDD)

Timeframe: from baseline to day 20

Trial details

NCT IDNCT05262868

SponsorCentre Hospitalier Universitaire Vaudois

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-31