NCT05188105Completed
Alpha tACS in Dementia With Lewy Bodies
Interventional Cross-over Study to Evaluate the Efficacy of Transcranial Alternating Current Stimulation (tACS) on Cognitive Performance in Patients With Dementia With Lewy Bodies
Source: ClinicalTrials.gov · Last updated 28 Mar 2024
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". Dementia with Lewy bodies (DLB), which is the second most frequent cause of neurodegenerative dementia, is characterized by an important alteration of brain oscillations. The restoration of oscillations by neuronal entrainment in animal models of neurodegenerative disease has shown a significant reduction in the neuropathological load of toxic proteins, with a consequent significant increase in cognitive performance. 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 alpha tACS is proposed in patients with DLB. In this randomized, double-blind, sham-controlled, cross-over study, the investigators will evaluate whether a single stimulation with alpha tACS on the occipital lobes can improve symptoms in patients with DLB.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 14 Nov 2021
- Start date
- 18 Oct 2021
- Primary completion date
- 10 Mar 2024
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Diseases
- Lewy body dementia
- NCT number
- NCT05188105
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 18 Oct 2021 to the primary completion date, 10 Mar 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
- Cerebrovascular disorders, previous stroke, hydrocephalus, and intra-cranial mass documented by MRI.
- Metal implants in the head (except dental fillings)
- Electronic implants (i.e. pace-maker, implanted medical pump)
Other illness
- History of traumatic brain injury or other neurological diseases.
- Serious medical illness other than DLB
- History of seizures
Age
- Age \<18 years
Other
- Pregnancy
Who the study is looking for
- Dementia with Lewy bodies (criteria according to McKeith, Neurology 2017).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ASST Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.