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The Clinical Trial will systematically examine the feasibility of remote, caregiver-led tACS for older adults with memory deficits and evaluate whether repeated tACS leads to sustained improvement of neuronal activity and memory functions.
The proposed investigation will systematically examine the feasibility and efficacy of remote, caregiver-led tACS for older adults with memory decline. This study will provide data to support the safety and effectiveness of home-based tACS in this population and will lead to future research to increase access to tACS as a part of memory decline prevention and treatment for older adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial alternating current stimulation (tACS) | Experimental | The randomized, sham-controlled, parallel-arm, double-blind clinical trial will include 4 weeks of daily, home-based stimulation sessions. MCI patients will be randomly assigned to the active or sham group. |
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| neurophysiological (hdEEG) | Experimental | At the baseline and after 4 weeks, MCI patients will be evaluated in the laboratory using hdEEG. |
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| clinical measures (MoCA) | Experimental | At the baseline and after 4 weeks, MCI patients will be evaluated in the laboratory using MoCA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial alternating current stimulation (tACS) | Device | tACS will be delivered by a battery-driven current stimulator Starstim SS32 (Neuroelectrics) through surface Ag/AgCl electrodes placed into holes of a neoprene cap corresponding to the international 10/20 EEG system. Gel (Parker Lab, Inc.) will be applied to optimize signal conductivity and lower impedance. Two tACS (active and sham) conditions will be applied in randomized order. 40 Hz tACS will be delivered to different brain areas of the memory network. We will employ a multielectrode montage based on electric field modeling using the individual MRI to optimally reach the target areas. The maximum injected current per electrode is 2mA and the overall maximal current is 4mA to generate an average electric field of 0.25 V/m. |
| Measure | Description | Time Frame |
|---|---|---|
| cognitive status measured by Montreal Cognitive Assessment (MoCA) | The primary objective is to characterize cognitive status at baseline and after 4 weeks of the home-based stimulation intervention. | baseline, after 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| modulation of gamma activity assessed with high-density EEG | The secondary objective is to assess with hdEEG any changes in gamma power at baseline and after 4 weeks of the home-based stimulation intervention. | baseline, after 4 weeks, |
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Inclusion Criteria:
Mild Cognitive Impairment (MCI) patients
Caregiver
Exclusion Criteria:
Mild Cognitive Impairment (MCI) patients
Caregiver
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucie Bréchet, PhD | Contact | +41 22 379 08 52 | lucie.brechet@unige.ch |
| Name | Affiliation | Role |
|---|---|---|
| Lucie Bréchet, PhD | University of Geneva (UNIGE) | Principal Investigator |
| Paul G Unschuld, PhD | Geneva University Hospitals (HUG) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Geneva, Campus Biotech | Recruiting | Geneva | 1202 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30902640 | Background | Brechet L, Brunet D, Birot G, Gruetter R, Michel CM, Jorge J. Capturing the spatiotemporal dynamics of self-generated, task-initiated thoughts with EEG and fMRI. Neuroimage. 2019 Jul 1;194:82-92. doi: 10.1016/j.neuroimage.2019.03.029. Epub 2019 Mar 19. | |
| 34485630 | Background | Brechet L, Michel CM, Schacter DL, Pascual-Leone A. Improving autobiographical memory in Alzheimer's disease by transcranial alternating current stimulation. Curr Opin Behav Sci. 2021 Aug;40:64-71. doi: 10.1016/j.cobeha.2021.01.003. Epub 2021 Feb 14. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| high-density electroencephalography (hdEEG) | Device | EEG will be recorded with a 257-channel EEG system. An EEG net is applied at once on the head with evenly spaced sensors that provide full scalp coverage, including the cheek. The net contains Ag/Ag-Cl electrodes that are interconnected by thin rubber bands and contain small sponges soaked with saline water that touch the participant's scalp surface directly. Net application takes about 10 min to derive to impedances of <30 kOhms. EEG is recorded with 1 kHz and band-pass filtered between DC-200 Hz. Vertex electrode Cz is used as an acquisition reference. |
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| Montreal Cognitive Assessment (MoCA) | Diagnostic Test | Clinical Evaluation and Cognitive Assessment - to characterize the level of dementia and changes in cognitive status measured at the baseline and after 4 weeks of gamma/sham tACS intervention, and in a follow-up 3 months after the stimulation using MoCA. |
|
| 34093384 | Background | Brechet L, Yu W, Biagi MC, Ruffini G, Gagnon M, Manor B, Pascual-Leone A. Patient-Tailored, Home-Based Non-invasive Brain Stimulation for Memory Deficits in Dementia Due to Alzheimer's Disease. Front Neurol. 2021 May 20;12:598135. doi: 10.3389/fneur.2021.598135. eCollection 2021. |
| 35607946 | Background | Benussi A, Cantoni V, Grassi M, Brechet L, Michel CM, Datta A, Thomas C, Gazzina S, Cotelli MS, Bianchi M, Premi E, Gadola Y, Cotelli M, Pengo M, Perrone F, Scolaro M, Archetti S, Solje E, Padovani A, Pascual-Leone A, Borroni B. Increasing Brain Gamma Activity Improves Episodic Memory and Restores Cholinergic Dysfunction in Alzheimer's Disease. Ann Neurol. 2022 Aug;92(2):322-334. doi: 10.1002/ana.26411. Epub 2022 Jun 6. |
| 41834385 | Derived | Bouhour C, Konstantopoulou S, Piton T, Tingaud M, Mauriello C, Lory K, Unschuld PG, Brechet L. Family caregiver perspectives on administering home-based stimulation in patients with mild cognitive impairment. J Alzheimers Dis. 2026 May;111(1):249-257. doi: 10.1177/13872877261429857. Epub 2026 Mar 15. |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |