Status:
UNKNOWN
rTMS for the Treatment of Affective Symptoms in Patients Suffering From Dementia
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Conditions:
Behavioral and Psychiatric Symptoms of Dementia
Eligibility:
All Genders
65+ years
Phase:
PHASE4
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05262868
Start Date
January 1 2022
End Date
January 31 2024
Last Update
March 2 2022
Active Locations (1)
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1
Supaa - Chuv
Prilly, Canton of Vaud, Switzerland, 1008