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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05262868
Other study ID # 2021-D0067
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date January 1, 2022
Est. completion date January 31, 2024

Study information

Verified date February 2022
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
rTMS
The stimulus intensity will be 80% of the motor threshold and the frequency will be 20 Hz for all patients. The total number of pulses will be 1200 for a single treatment session. We plan a total of 15 sessions distributed over 5 days a week for 3 consecutive weeks.

Locations

Country Name City State
Switzerland Supaa - Chuv Prilly Vaud

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

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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