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Personalized Repetitive Transcranial Magnetic Stimulation (rTMS) in Cognitive Fluctuations of Dementia With Lewy Bodies (DLB): Proof of Concept

NCT05138588 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-08

No results posted yet for this study

Summary

The present study is a monocentric, therapeutic clinical trial involving forty patients diagnosed with Dementia with Lewy Bodies (DLB). The aim of this clinical trial is to evaluate the feasibility and relevance of repetitive transcranial magnetic stimulation (rTMS); a non-invasive neuromodulation technique, with a main emphasis on the evaluation of the outcome on cognitive fluctuations. For this purpose, we will compare two distinct rTMS conditions (control and experimental) in a pre-post rTMS setting. The experimental condition will be targeting the insular cortex which has been shown to be affected at prodromal DLB stages, in the form of decreased grey matter concentration and a decreased regional Cerebral Blood Flow (rCBF hypoperfusion) \[Blanc et al., 2015 ; Roquet et al., 2016 ; Roquet et al., 2017\]. Furthermore, these insular alterations are correlated to cognitive fluctuations \[Chabran et al., 2020\]. In DLB, cognitive fluctuations are particularly pervasive and manifest in the form of alertness alterations and modifications of arousal states. Participants will repeatedly undergo a series of clinical and cognitive assessments in addition to several neuroimaging examinations, namely multimodal Magnetic Resonance Imaging (MRI) and electroencephalogram (EEG) recordings, in order to evaluate potential physiological modifications and clinical changes of symptoms, pre-/post-rTMS.

Conditions

  • Dementia With Lewy Bodies Diagnosis
  • Significant Cognitive Fluctuations in DLB

Interventions

DEVICE

rTMS

For each subject, a verum condition and a control condition will be programmed. We will use the QPS-5 method (4 pulses, Inter-Stimulation Interval; ISI: 5 seconds).

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Frédéric BLANC · Hôpitaux Universitaires de Strasbourg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-02
Primary Completion
2028-02-29
Completion
2028-07-31

Countries

  • France

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 NCT05138588 on ClinicalTrials.gov