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

NCT05262868 | Unknown Phase 4

• 1 other identifier: 2021-D0067
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cornell Scale for Depression in Dementia (CSDD)

  Mood assessment tool

  from baseline to day 20

Secondary Outcomes (4)

• Montreal Cognitive Assessment (MOCA)

  from baseline to day 20

• NPI-Q

  from baseline to day 20

• The ratio of patients who completed the study and drop-outs due to non-compliance

  During all the study period

• Possible changes of structural MRI before as compared to after the treatment

  from baseline to day 20

Study Arms (2)

Active

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

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

Interventions

rTMS 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.

Active; Sham

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of schizophrenia, bipolar disorder, schizoaffective disorder
• History of macroscopic stroke.
• Unstable somatic pathologies
• Insufficient collaboration for the rTMS procedure
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Supaa - Chuv

Prilly, Canton of Vaud, 1008, Switzerland

Location

MeSH Terms

Conditions

Behavior

Study Officials

• Armin von Gunten, MD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 2, 2022
• Study Start: January 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: January 31, 2024
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)