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NCT05643326Completed

At Home Gamma tACS in Alzheimer's Disease (tACS@Home)

Markers of Clinical and Biological Response to Home Delivered Transcranial Alternating Current Stimulation (tACS) in Patients With Alzheimer's Disease

Source: ClinicalTrials.gov · Last updated 17 Apr 2025

Brief summary (registry, in English)

Brain oscillations are ubiquitous in the human brain and have been implicated in cognitive and behavioral states defined in precisely tuned neural networks. In neurodegenerative disorders, neurodegeneration is accompanied by changes in oscillatory activity leading to the emerging concept of neurological and psychiatric disorders as "oscillopathies". Alzheimer's disease, which accounts for the vast majority of age-related dementias, is characterised by a prominent disruption of oscillations in the gamma frequency band. The restoration of gamma oscillations by neural entrainment in animal models of Alzheimer's disease have shown a remarkable decrease in the pathological burden of amyloid and tau via increased microglial activity, resulting in a significant increase of cognitive performances. Transcranial alternating current brain stimulation (tACS), is a neurophysiological method of non-invasive modulation of the excitability of the central nervous system that is having an increasingly numerous spectrum of potential therapeutic applications. Recent studies have demonstrated the effectiveness of this method in modulating the natural frequencies of cerebral oscillation, underlying multiple cognitive processes such as verbal memory, perception and working memory. On the basis of these premises, the treatment with gamma tACS is proposed in patients affected by Alzheimer's disease. In this randomized, double-blind, sham-controlled study, followed by an open-label phase, the investigators will evaluate whether a 9- or 18-weeks treatment with gamma tACS over the precuneus, delivered at home, can improve symptoms in patients with mild Alzheimer's disease.

Status (registry)
Completed
Study type
Interventional
Enrollment
53 (actual)
First submitted
24 Nov 2022
Start date
10 Dec 2022
Primary completion date
15 Oct 2024
Lead sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
NCT number
NCT05643326

What you commit to

  • Study type: Interventional
  • Participants enrolled: 53
  • From 10 Dec 2022 to the primary completion date, 15 Oct 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous stroke
  • Metal implants in the head (except dental fillings)
  • Electronic implants (i.e. pace-maker, implanted medical pump)

Other illness

  • Cerebrovascular disorders
  • History of traumatic brain injury or other neurological diseases
  • Serious medical illness other than AD
  • History of seizures

Age

  • Age \<18 years

Other

  • Hydrocephalus
  • Intra-cranial mass documented by MRI
  • Pregnancy

Who the study is looking for

  • Mild Alzheimer's disease (CDR 0.5 - 1)
  • Age \> 18 years
  • Compliance in participation in training on the use of the therapeutic device
  • Mini-Mental State Examination \>26/30

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ASST Spedali Civili di Brescia
Coordinator of this site? Confirm its status
BresciaItalyUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.