rTMS for the Treatment of Affective Symptoms in Patients Suffering From Dementia

Phase 4

• Conditions: Behavioral and Psychiatric Symptoms of Dementia
• Interventions: Device: rTMS

• Registration Number: NCT05262868
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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 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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-02-21
• Last Update Submitted: 2022-02-21
• Study First Posted: 2022-03-02
• Last Update Posted: 2022-03-02
• Primary Completion: 2023-10-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	rTMS	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
Sham	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).

Primary Outcome Measures

Name	Time	Method
Cornell Scale for Depression in Dementia (CSDD)	from baseline to day 20	Mood assessment tool

Secondary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MOCA)	from baseline to day 20	Cognitive assessment tool
NPI-Q	from baseline to day 20	Behavioural assessment tool for demented patients
The ratio of patients who completed the study and drop-outs due to non-compliance	During all the study period	Compliance assessment tool
Possible changes of structural MRI before as compared to after the treatment	from baseline to day 20	quantitative structural MRI protocol allowing for an optimal segmentation - resolution of grey versus white matter including cortical and sub-cortical brain structures.

Trial Locations

Locations (1)

Supaa - Chuv; 🇨🇭 Prilly, Vaud, Switzerland