rTMS for the Treatment of Affective Symptoms in Patients Suffering From Dementia (rTMS-PSYGER)

Vaud University Hospital Center

Status and phase: Unknown; Phase 4

Conditions: Behavioral and Psychiatric Symptoms of Dementia

Treatments: Device: rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT05262868

2021-D0067

Details and patient eligibility

About

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

Enrollment: 44 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

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

Treatment:

Device: rTMS

Sham

Placebo Comparator group

Description:

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).

Treatment:

Device: rTMS