RecruitingNot ApplicableNCT05708001

Improvement of Memory in Mild Cognitive Impairment

Improvement of Memory in Mild Cognitive Impairment (MCI) Using Transcranial Alternating Current Stimulation (tACS) Guided by EEG and MRI: a Randomized, Sham-controlled, Parallel-arm, Double-blind Study


Sponsor

Lucie Bréchet

Enrollment

40 participants

Start Date

Feb 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 55 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Montreal Cognitive Assessment (MoCA), a medical device called high-density electroencephalography (hdEEG), and others for people with mild cognitive impairment. The study is currently recruiting participants at 1 location. People eligible for this study include aged 55 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEtranscranial alternating current stimulation (tACS)

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.

DEVICEhigh-density electroencephalography (hdEEG)

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.

DIAGNOSTIC_TESTMontreal Cognitive Assessment (MoCA)

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.


Locations(1)

University of Geneva, Campus Biotech

Geneva, Switzerland

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NCT05708001


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