Improvement of Memory in Mild Cognitive Impairment

ConditionMild Cognitive Impairment

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age55-85

SponsorLucie Bréchet

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

age ≥ 55 years old

clinical diagnosis of mild cognitive impairment (MCI) based on a comprehensive clinical assessment and standard neuropsychological examination including tests of language, visuospatial thinking, executive functions, and memory

confirmation of diagnosis will be made by Prof. Paul Unschuld, the study MD, based on a participant's cognitive evaluation and history

understanding of the informed consent

Disqualifiers

age < 55 years old

any current diagnosis of a psychiatric disorder (e.g., schizophrenia, bipolar disorder, depressive disorder)

other than MCI, any history of other progressive or genetic neurologic disorder (e.g., Parkinson's disease, multiple sclerosis, tubular sclerosis) or acquired neurological disease (e.g., stroke, traumatic brain injury, tumor), including intracranial lesions

history of head trauma resulting in prolonged loss of consciousness

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.
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.

Treatment groups

40 Participants

are divided into 3 treatment groups

Group A: Transcranial alternating current stimulation (tACS)Experimental treatment 1 intervention

Group B: neurophysiological (hdEEG)Experimental treatment 1 intervention

Group C: clinical measures (MoCA)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

baseline, after 4 weeks

Secondary outcomes

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.

Time frame

baseline, after 4 weeks,

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lucie Bréchet

Lead sponsor

University of Geneva, Switzerland

Sponsor institution

Source ClinicalTrials.gov

Apply now