Home-based transcranial alternating current stimulation (tACS) in Alzheimer’s disease: rationale and study design
Abstract Background Gamma (γ) brain oscillations are dysregulated in Alzheimer’s disease (AD) and can be modulated using transcranial alternating stimulation (tACS). In the present paper, we describe the rationale and design of a study assessing safety, feasibility, clinical and biological efficacy,...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-09-01
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| Series: | Alzheimer’s Research & Therapy |
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| Online Access: | https://doi.org/10.1186/s13195-023-01297-4 |
| _version_ | 1827724196914921472 |
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| author | Daniele Altomare Alberto Benussi Valentina Cantoni Enrico Premi Jasmine Rivolta Chiara Cupidi Alessandro Martorana Emiliano Santarnecchi Alessandro Padovani Giacomo Koch Barbara Borroni |
| author_facet | Daniele Altomare Alberto Benussi Valentina Cantoni Enrico Premi Jasmine Rivolta Chiara Cupidi Alessandro Martorana Emiliano Santarnecchi Alessandro Padovani Giacomo Koch Barbara Borroni |
| author_sort | Daniele Altomare |
| collection | DOAJ |
| description | Abstract Background Gamma (γ) brain oscillations are dysregulated in Alzheimer’s disease (AD) and can be modulated using transcranial alternating stimulation (tACS). In the present paper, we describe the rationale and design of a study assessing safety, feasibility, clinical and biological efficacy, and predictors of outcome of a home-based intervention consisting of γ-tACS over the precuneus. Methods In a first phase, 60 AD patients will be randomized into two arms: ARM1, 8-week precuneus γ-tACS (frequency: 40 Hz, intensity: 2 mA, duration: 5 60-min sessions/week); and ARM2, 8-week sham tACS (same parameters as the real γ-tACS, with the current being discontinued 5 s after the beginning of the stimulation). In a second phase, all participants will receive 8-week γ-tACS (same parameters as the real γ-tACS in the first phase). The study outcomes will be collected at several timepoints throughout the study duration and include information on safety and feasibility, neuropsychological assessment, blood sampling, electroencephalography, transcranial magnetic stimulation neurotransmitter measures, and magnetic resonance imaging or amyloid positron emission tomography. Results We expect that this intervention is safe and feasible and results in the improvement of cognition, entrainment of gamma oscillations, increased functional connectivity, reduction of pathological burden, and increased cholinergic transmission. Conclusions If our expected results are achieved, home-based interventions using γ-tACS, either alone or in combination with other therapies, may become a reality for treating AD. Trial registration PNRR-POC-2022–12376021. |
| first_indexed | 2024-03-10T22:11:19Z |
| format | Article |
| id | doaj.art-5d54ca9fdcc74997a5b33fc7902b50f3 |
| institution | Directory Open Access Journal |
| issn | 1758-9193 |
| language | English |
| last_indexed | 2024-03-10T22:11:19Z |
| publishDate | 2023-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Alzheimer’s Research & Therapy |
| spelling | doaj.art-5d54ca9fdcc74997a5b33fc7902b50f32023-11-19T12:35:43ZengBMCAlzheimer’s Research & Therapy1758-91932023-09-011511910.1186/s13195-023-01297-4Home-based transcranial alternating current stimulation (tACS) in Alzheimer’s disease: rationale and study designDaniele Altomare0Alberto Benussi1Valentina Cantoni2Enrico Premi3Jasmine Rivolta4Chiara Cupidi5Alessandro Martorana6Emiliano Santarnecchi7Alessandro Padovani8Giacomo Koch9Barbara Borroni10Department of Clinical and Experimental Sciences, Neurology Unit, University of BresciaDepartment of Clinical and Experimental Sciences, Neurology Unit, University of BresciaDepartment of Clinical and Experimental Sciences, Neurology Unit, University of BresciaStroke Unit, ASST Spedali CiviliDepartment of Clinical and Experimental Sciences, Neurology Unit, University of BresciaNeurology Unit, Fondazione Istituto G. GiglioDepartment of Systems Medicine, Memory Clinic, University of Rome Tor Vergata Department of Radiology, Precision Neuroscience and Neuromodulation Program, Gordon Center for Medical Imaging, Massachusetts General Hospital, Harvard Medical SchoolDepartment of Clinical and Experimental Sciences, Neurology Unit, University of BresciaDepartment of Clinical and Behavioral Neurology, Fondazione Santa Lucia IRCCSDepartment of Clinical and Experimental Sciences, Neurology Unit, University of BresciaAbstract Background Gamma (γ) brain oscillations are dysregulated in Alzheimer’s disease (AD) and can be modulated using transcranial alternating stimulation (tACS). In the present paper, we describe the rationale and design of a study assessing safety, feasibility, clinical and biological efficacy, and predictors of outcome of a home-based intervention consisting of γ-tACS over the precuneus. Methods In a first phase, 60 AD patients will be randomized into two arms: ARM1, 8-week precuneus γ-tACS (frequency: 40 Hz, intensity: 2 mA, duration: 5 60-min sessions/week); and ARM2, 8-week sham tACS (same parameters as the real γ-tACS, with the current being discontinued 5 s after the beginning of the stimulation). In a second phase, all participants will receive 8-week γ-tACS (same parameters as the real γ-tACS in the first phase). The study outcomes will be collected at several timepoints throughout the study duration and include information on safety and feasibility, neuropsychological assessment, blood sampling, electroencephalography, transcranial magnetic stimulation neurotransmitter measures, and magnetic resonance imaging or amyloid positron emission tomography. Results We expect that this intervention is safe and feasible and results in the improvement of cognition, entrainment of gamma oscillations, increased functional connectivity, reduction of pathological burden, and increased cholinergic transmission. Conclusions If our expected results are achieved, home-based interventions using γ-tACS, either alone or in combination with other therapies, may become a reality for treating AD. Trial registration PNRR-POC-2022–12376021.https://doi.org/10.1186/s13195-023-01297-4Alzheimer’s diseaseElectrical stimulationtACSBiomarkersCognitionMemory |
| spellingShingle | Daniele Altomare Alberto Benussi Valentina Cantoni Enrico Premi Jasmine Rivolta Chiara Cupidi Alessandro Martorana Emiliano Santarnecchi Alessandro Padovani Giacomo Koch Barbara Borroni Home-based transcranial alternating current stimulation (tACS) in Alzheimer’s disease: rationale and study design Alzheimer’s Research & Therapy Alzheimer’s disease Electrical stimulation tACS Biomarkers Cognition Memory |
| title | Home-based transcranial alternating current stimulation (tACS) in Alzheimer’s disease: rationale and study design |
| title_full | Home-based transcranial alternating current stimulation (tACS) in Alzheimer’s disease: rationale and study design |
| title_fullStr | Home-based transcranial alternating current stimulation (tACS) in Alzheimer’s disease: rationale and study design |
| title_full_unstemmed | Home-based transcranial alternating current stimulation (tACS) in Alzheimer’s disease: rationale and study design |
| title_short | Home-based transcranial alternating current stimulation (tACS) in Alzheimer’s disease: rationale and study design |
| title_sort | home based transcranial alternating current stimulation tacs in alzheimer s disease rationale and study design |
| topic | Alzheimer’s disease Electrical stimulation tACS Biomarkers Cognition Memory |
| url | https://doi.org/10.1186/s13195-023-01297-4 |
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