Behavioral and Psychiatric Symptoms of Dementia Clinical Trial
— rTMS-PSYGEROfficial title:
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Affective Symptoms in Patients Suffering From Dementia: a Randomised Clinical Trial
Verified date | February 2022 |
Source | Centre Hospitalier Universitaire Vaudois |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 44 |
Est. completion date | January 31, 2024 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 S (*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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Supaa - Chuv | Prilly | Vaud |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Vaudois |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cornell Scale for Depression in Dementia (CSDD) | Mood assessment tool | from baseline to day 20 | |
Secondary | Montreal Cognitive Assessment (MOCA) | Cognitive assessment tool | from baseline to day 20 | |
Secondary | NPI-Q | Behavioural assessment tool for demented patients | from baseline to day 20 | |
Secondary | The ratio of patients who completed the study and drop-outs due to non-compliance | Compliance assessment tool | During all the study period | |
Secondary | 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 |
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