A Phase 4 interventional study of rTMS in Behavioral and Psychiatric Symptoms of Dementia, sponsored by Centre Hospitalier Universitaire Vaudois. Status unknown at 1 site in Switzerland. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by Centre Hospitalier Universitaire Vaudois · Phase 4, Interventional, and Treatment
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
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 44 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Centre Hospitalier Universitaire Vaudois is the lead sponsor of 203 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Magnetic stimulus intensity of 80% of the motor threshold applied at the frequency of 20 Hz over the left DLPFC with a total number of pulses of 1200 / treatment session for a total of 5 sessions /week for 3 consecutive weeks
Device: rTMS
Sham procedure implies the use of a "sham" coil of exactly the same dimension and appearance as the one used for the effective treatment. This sham coil is made for research purposes by the producing company and used in accordance with the instructions for use, which explicitly mention it (cf. instruction manual page 34: Stimulation Coil DuoMAG 70BFP (70BFP1, 70BFP2), typical use for blinded studies).
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.
Cornell Scale for Depression in Dementia (CSDD)
Mood assessment tool
Time frame: from baseline to day 20
Montreal Cognitive Assessment (MOCA)
Cognitive assessment tool
Time frame: from baseline to day 20
NPI-Q
Behavioural assessment tool for demented patients
Time frame: from baseline to day 20
The ratio of patients who completed the study and drop-outs due to non-compliance
Compliance assessment tool
Time frame: During all the study period
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.
Time frame: from baseline to day 20
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire Vaudois