Repetitive Transcranial Magnetic Stimulation in Frontotemporal Lobar Degeneration (FTLD_rTMS)

Università degli Studi di Brescia

Status: Enrolling

Conditions: PPA; FTLD; PSP; Cortical Basal Syndrome (CBS); FTD; Theta Burst Stimulation; rTMS; bvFTD

Treatments: Device: Sham Theta burst stimulation; Device: Theta burst stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07316413

FTLD_rTMS

Details and patient eligibility

About

The aim of the study is to evaluate the safety, feasibility, clinical and biological efficacy, and predictors of efficacy of an intervention consisting of repetitive transcranial magnetic stimulation (rTMS) in patients with frontotemporal dementia (FTLD) or in asymptomatic persons at risk of FTLD (i.e., persons familiar with FTLD patients).

rTMS is a non-invasive brain stimulation technique, and has demonstrated the ability to modulate neuronal activity by applying high-frequency magnetic fields to the surface of the skull. rTMS offers a potentially effective means to influence neural networks involved in the pathogenesis of neurodegenerative diseases, with benefits that could extend beyond symptomatic relief. Its safety has been widely documented in a variety of clinical conditions, making it an ideal candidate for application in neurodegenerative diseases.

In the present study, participants will undergo the following procedures: (i) clinical and neuropsychological assessment, (ii) TMS, and (iii) blood sampling. The occurrence of adverse events will be monitored throughout the duration of the study.

The study is structured in two phases. In the first phase, double-blind, randomised and placebo-controlled, participants will be randomised into two groups: group 1, participants will receive real rTMS for 2 weeks; and group 2, placebo rTMS for 2 weeks. In the second, open-label phase, after 10 weeks, both group 1 and group 2 participants will receive real rTMS for 2 weeks. Each participant will receive a total of 4 weeks of intervention (4 weeks of real stimulation in group 1, or 2 weeks of real stimulation and 2 weeks of placebo stimulation in group 2), with 5 sessions per week (Monday to Friday) lasting approximately 30 minutes each.

Visits will take place at the beginning of the study (T00) and after 2 weeks (T02, end of the first phase), 12 weeks (T12, beginning of the second phase), 14 weeks (T14, end of the second phase), 24 weeks (T24, follow-up). During each visit, participants underwent the following procedures: (i) clinical and neuropsychological assessment, (ii) blood sampling, and (iii) TMS. Specific biomarker analyses will be performed on the blood samples to study the pathophysiological mechanisms of the disease and the effect of the experimental intervention.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of FTLD (bvFTD, avPPA, svPPA, CBS, or PSP)
• global CDR plus NACC FTLD ≤ 1

Exclusion criteria

• presence of cerebrovascular disease, hydrocephalus, intracranial masses identified by MRI, history of head trauma, serious medical conditions unrelated to FTLD, history of epilepsy, and presence of electronic (e.g., pacemaker) or metallic implants in the head.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Real iTBS - Real iTBS

Experimental group

Description:

10 sessions of theta burst stimulation (5 days/week for 2 weeks) followed by an open-label 10 sessions of theta burst stimulation (5 days/week for 2 weeks)

Treatment:

Device: Theta burst stimulation

Sham iTBS - Real iTBS

Sham Comparator group

Description:

10 sessions of sham stimulation (5 days/week for 2 weeks) followed by an open-label 10 sessions of theta burst stimulation (5 days/week for 2 weeks)

Treatment:

Device: Theta burst stimulation

Device: Sham Theta burst stimulation