An interventional study of Alpha tACS (12 Hz) over the occipital cortex in Dementia With Lewy Bodies and Lewy Body Disease, sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-28.
Sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Not applicable, Interventional, and Treatment
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.
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 15 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia is the lead sponsor of 81 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single session of alpha tACS (12 Hz) at 3 mA over the occipital cortex.
Device: Alpha tACS (12 Hz) over the occipital cortex
Single session of sham tACS over the occipital cortex.
Device: Alpha tACS (12 Hz) over the occipital cortex
Single session of alpha tACS (12 Hz) over the occipital cortex
Changes in Visual Search Task Test scores
The visual search task requires participants to determine whether a target (such as a particular letter, shape, or image) is present in an array of other stimuli. The task consists of two parts, each with 64 stimuli, for a total of 128 stimuli. Participants are asked to look at the screen and press a button if the target stimulus is present or another button if the target stimulus is absent. After pressing the chosen button, a feedback will appear on the screen that will tell the subject if his answer is correct or incorrect. Subjects must respond as quickly as possible, otherwise the answer will be considered missed and they will proceed to the next screen. The score ranges from 0 (worse performance) to 128 (best performance).
Time frame: 40 minutes after the start of the intervention
Changes in Rey Auditory Verbal Learning Test scores
Participants are given a list of 15 unrelated words repeated over five different trials and are asked to repeat. Another list of 15 unrelated words are given and the patient must again repeat the original list of 15 words and then again after 30 minutes. The score ranges from 0 (worse performance) to 15 (best performance).
Time frame: Baseline (immediately before the intervention) - Immediately after the intervention
Changes in Trail Making Test Part A
The Trail Making Test Part A consists of 25 circles on a piece of paper with the numbers 1-25 written randomly in the circles. The test taker's task is to start with number one and draw a line from that circle to the circle with the number two in it to the circle with the three in it, etc. The person continues to connect the circles in numerical order until they reach number 25. Scoring is based on time taken to complete the test with lower scores being better.
Time frame: Baseline (immediately before the intervention) - Immediately after the intervention
Changes in Trail Making Test Part B
The Trail Making Test Part B consists of 24 circles on a piece of paper, but rather than all of the circles containing numbers, half of the circles have the numbers 1-12 in them and the other half (12) contain the letters A-L. The person taking the test has to draw a line from one circle to the next in ascending order; however, he must alternate the circles with numbers in them (1-13) with circles with letters in them (A-L). In other words, he is to connect the circles in order like this: 1-A-2-B-3-C-4-D-5-E and so on. Scoring is based on time taken to complete the test with lower scores being better.
Time frame: Baseline (immediately before the intervention) - Immediately after the intervention
Changes in relative alpha power in occipital EEG leads
By using electroencephalography (EEG), the investigators will evaluate the effects of alpha tACS on relative alpha power in occipital EEG leads.
Time frame: Baseline (immediately before the intervention) - Immediately after the intervention
Change in SAI measurements
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of alpha tACS on short latency afferent inhibition (SAI), which is a marker of cholinergic transmission.
Time frame: Baseline (immediately before the intervention) - Immediately after the intervention
Change in SICI measurements
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of alpha tACS on short interval intracortical inhibition (SICI), which is a marker of GABAergic transmission.
Time frame: Baseline (immediately before the intervention) - Immediately after the intervention
Change in ICF measurements
By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of alpha tACS on intracortical facilitation (ICF), which is a marker of glutamatergic transmission.
Time frame: Baseline (immediately before the intervention) - Immediately after the intervention
Plan to share: Yes — All data, including outcome measure results, study protocol and statistical analysis plan, will be shared upon reasonable request.
Supporting information: Study protocol, Sap
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia