Sensitivity of revised diagnostic criteria for the behavioural variant of frontotemporal dementia.
Katya Rascovsky, John R Hodges, David Knopman...
https://pubmed.ncbi.nlm.nih.gov/21810890Actively Recruiting
Phase Not Applicable
Age: 40Years +
All Genders
ID07505784
Cross-over Study to Evaluate Safety, Tolerability, and Clinical Effects of Transcranial Alternating Current Stimulation in Frontotemporal Dementia Patients
Led by IRCCS Centro San Giovanni di Dio Fatebenefratelli · Updated on 2026-04-01
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, feasibility, and clinical effects of transcranial alternating current stimulation (tACS) in patients with Frontotemporal Dementia (FTD). FTD is associated with changes in brain oscillations, and restoring these oscillations has shown promising results in animal models by reducing toxic protein buildup and improving cognitive function. This study aims to assess how a single session of tACS affects cognitive performance, brain synchronization, and neurophysiological markers in people with FTD. Participants will be randomly assigned to one of two groups in a crossover design. Group 1 receives a real 60-minute tACS session first, followed by a sham (placebo) tACS session one week later. Group 2 starts with the sham session and then receives the real tACS session after one week. The real tACS involves a 2.5 mA electrical current applied to the brain, while the sham session mimics the process but stops the current shortly after starting to keep participants unaware of the treatment type. During the study, participants will undergo cognitive tests and neurophysiological assessments immediately before and after each stimulation session. These include fluency tests, memory tasks, and EEG recordings to measure brain activity changes. Researchers will monitor safety and tolerability for about one week after each session. The study is designed to identify clinical effects, brain changes, and possible predictors of response to tACS in FTD patients.
CONDITIONS
Brief Title
Transcranial Alternating Current Stimulation in Frontotemporal Dementia
Who Can Participate
Age: 40Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged over 40 years at the time of signing the informed consent form
- Clinical diagnosis of Frontotemporal Dementia according to established clinical criteria (Rascovsky et al., 2011; Gorno-Tempini et al., 2011)
You will not qualify if you...
- Age younger than 40 years
- Inability to understand the study procedures
- Cardiac pacemaker or metal implants incompatible with electric or magnetic fields
- History of epilepsy
- Current pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 2 weeks
Participants receive two sessions of Transcranial Alternating Current Stimulation (real and sham) in a crossover design with one week between sessions.
2 sessions, each lasting 60 minutes, with 1 week between sessions
Trial Site Locations
Total: 1 location
1
IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli
Brescia, BS, Italy, 25125
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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