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

NCT05262868 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-03-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Principal Investigators

  • Armin von Gunten, MD · Centre Hospitalier Universitaire Vaudois

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-10-31
Completion
2024-01-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05262868 on ClinicalTrials.gov