Clinical trial NCT05262868: rTMS for the Treatment of Affective Symptoms in Patients Suffering From Dementia
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Affective Symptoms in Patients Suffering From Dementia: a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Behavioral and Psychiatric Symptoms of Dementia
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 44
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Cornell Scale for Depression in Dementia (CSDD)
timeFrame: from baseline to day 20
Secondary outcomes:
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: from baseline to day 20
measure: NPI-Q
timeFrame: from baseline to day 20
measure: The ratio of patients who completed the study and drop-outs due to non-compliance
timeFrame: During all the study period
measure: Possible changes of structural MRI before as compared to after the treatment
timeFrame: from baseline to day 20
Other outcomes:
Locations:
city: Prilly
country: Switzerland
facility: Supaa - Chuv
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Armin von Gunten, MD
role: PRINCIPAL_INVESTIGATOR
References: