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

NCT ID: NCT05262868

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-01-31

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

Conditions

Behavioral and Psychiatric Symptoms of Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active

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

Group Type: ACTIVE_COMPARATOR

rTMS

Intervention Type: DEVICE

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.

Sham

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).

Group Type: PLACEBO_COMPARATOR

rTMS

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Prof Armin von Gunten

Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Armin von Gunten, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

Supaa - Chuv

Prilly, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

2021-D0067

Identifier Type: -

Identifier Source: org_study_id