Beta-frequency brain stimulation for frontotemporal dementia
Cross-over Study to Evaluate the Safety, Tolerability, and Clinical Efficacy of Transcranial Alternating Current Stimulation (tACS) in Patients With Frontotemporal Dementia
This trial will try a single session of beta-frequency transcranial alternating current stimulation (tACS) to see if it is safe and can improve brain rhythms and symptoms in people over 40 with frontotemporal dementia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli Academic / other |
| Locations | 1 site (Brescia, BS) |
| Trial ID | NCT07505784 on ClinicalTrials.gov |
What this trial studies
This is a single-center, randomized interventional trial applying one session of beta-frequency tACS versus sham in patients with clinically diagnosed frontotemporal dementia. The protocol focuses on safety, feasibility, short-term clinical effects, biological markers related to brain oscillations, and factors that predict response. tACS is a noninvasive neuromodulation method intended to entrain and restore disrupted brain oscillations implicated in cognitive function. Outcomes will include tolerability, physiological measures of oscillatory activity, and brief clinical cognitive assessments.
Who should consider this trial
Good fit: Adults aged over 40 with a clinical diagnosis of frontotemporal dementia who can give informed consent and have no contraindications to tACS (for example, no pacemaker, incompatible metal implants, epilepsy, or pregnancy) are eligible.
Not a fit: People younger than 40, those unable to understand or consent, or those with contraindications to electric or magnetic stimulation (pacemakers, incompatible metal implants, active epilepsy, pregnancy) are unlikely to participate or benefit.
Why it matters
Potential benefit: If successful, the intervention could safely restore disrupted brain rhythms and produce short-term improvements in cognitive symptoms or biomarkers in patients with FTD.
How similar studies have performed: Animal models show that restoring brain oscillations can reduce toxic protein accumulation and improve cognition, and human tACS studies have safely modulated cognitive-related oscillations, but tACS specifically in FTD remains largely novel with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female subjects aged over 40 years at the time of signing the informed consent form; * Presence of a clinical diagnosis of Frontotemporal Dementia according to clinical criteria (Rascovsky et al., 2011; Gorno-Tempini et al., 2011). Exclusion Criteria: * Age younger than that stated in the inclusion criterion; * Inability to understand; * Contraindications for tACS and TMS: cardiac pacemaker carriers and metal implants that are not compatible with electric or magnetic fields, history of epilepsy, current pregnancy (Safety Questionnaire)
Where this trial is running
Brescia, BS
- IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli — Brescia, Bs, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.