Clinical trial NCT05188105: Alpha tACS in Dementia With Lewy Bodies
Official title: Interventional Cross-over Study to Evaluate the Efficacy of Transcranial Alternating Current Stimulation (tACS) on Cognitive Performance in Patients With Dementia With Lewy Bodies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia With Lewy Bodies
Lewy Body Disease
Keywords: Dementia with Lewy bodies
Lewy Body Disease
Alpha stimulation
transcranial alternating current stimulation
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Subjects will be randomized in two groups, one receiving a single treatment with alpha tACS (12 Hz) first and the other receiving sham stimulation. After one week the treatments will be exchanged. Patients will be evaluated with neuropsychological tests and neurophysiological measures of cholinergic transmission.

Eligibility criteria: Inclusion Criteria:

* Dementia with Lewy bodies (criteria according to McKeith, Neurology 2017).

Exclusion Criteria:

* Cerebrovascular disorders, previous stroke, hydrocephalus, and intra-cranial mass documented by MRI.
* History of traumatic brain injury or other neurological diseases.
* Serious medical illness other than DLB
* History of seizures
* Pregnancy
* Metal implants in the head (except dental fillings)
* Electronic implants (i.e. pace-maker, implanted medical pump)
* Age \<18 years

Primary outcomes:
measure: Changes in Visual Search Task Test scores
timeFrame: 40 minutes after the start of the intervention
Secondary outcomes:
measure: Changes in Rey Auditory Verbal Learning Test scores
timeFrame: Baseline (immediately before the intervention) - Immediately after the intervention
measure: Changes in Trail Making Test Part A
timeFrame: Baseline (immediately before the intervention) - Immediately after the intervention
measure: Changes in Trail Making Test Part B
timeFrame: Baseline (immediately before the intervention) - Immediately after the intervention
measure: Changes in relative alpha power in occipital EEG leads
timeFrame: Baseline (immediately before the intervention) - Immediately after the intervention
measure: Change in SAI measurements
timeFrame: Baseline (immediately before the intervention) - Immediately after the intervention
measure: Change in SICI measurements
timeFrame: Baseline (immediately before the intervention) - Immediately after the intervention
measure: Change in ICF measurements
timeFrame: Baseline (immediately before the intervention) - Immediately after the intervention
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
state: BS
Study officials:
affiliation: ASST Spedali Civili di Brescia
name: Barbara Borroni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ASST Spedali Civili di Brescia
name: Alberto Benussi, MD
role: PRINCIPAL_INVESTIGATOR
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