rTMS for the Treatment of Affective Symptoms in Patients Suffering From Dementia (NCT05262868) | Clinical Trial Compass
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 range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.