Improvement of Memory in Mild Cognitive Impairment

July 9, 2025 updated by: Lucie Bréchet

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1202
        • Recruiting
        • University of Geneva, Campus Biotech
        • Contact:
          • Lucie Bréchet, PhD
        • Principal Investigator:
          • Lucie Bréchet, PhD
        • Sub-Investigator:
          • Paul G Unschuld, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Mild Cognitive Impairment (MCI) patients

  • 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
  • able and willing to comply with all study requirements
  • informed consent form was signed
  • women of childbearing potential (WOCBP) must perform a pregnancy test during screening

Caregiver

  • minimum 21 years of age
  • self-reported computer/tablet proficiency
  • willingness to learn how to use tACS
  • availability during the study period to administer tACS to the participant
  • informed consent form was signed
  • women of childbearing potential (WOCBP) must perform a pregnancy test during screening

Exclusion Criteria:

Mild Cognitive Impairment (MCI) patients

  • 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
  • current history of poorly controlled headaches including chronic medication for migraine prevention
  • history of fainting spells of unknown or undetermined etiology that might constitute seizures
  • history of seizures, diagnosis of epilepsy
  • any unstable medical condition or chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
  • contraindication for undergoing MRI or receiving tACS
  • any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g., MRI compatible joint replacement)
  • any skin problems, such as dermatitis, psoriasis, or eczema
  • any electrically, magnetically, or mechanically activated implanted devices such as a pacemaker, intracranial electrodes, implanted defibrillators, medication pumps, nerve stimulators, vascular clips, or any other prosthesis in the brain
  • any serious life-threatening disease such as congestive heart failure, pulmonary obstructive chronic disease, or active neoplasia
  • pregnant women
  • adults lacking capacity for consent

Caregiver

  • insufficient understanding of study procedures
  • poor eyesight, severe arthritis in the hands, pain, deformity or other condition that interferes with successful administration of tACS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial alternating current stimulation (tACS)
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.
Device: transcranial 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.
Experimental: neurophysiological (hdEEG)
At the baseline and after 4 weeks, MCI patients will be evaluated in the laboratory using hdEEG.
Device: high-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.
Experimental: clinical measures (MoCA)
At the baseline and after 4 weeks, MCI patients will be evaluated in the laboratory using MoCA.
Diagnostic test: Montreal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive status measured by Montreal Cognitive Assessment (MoCA)
Time Frame: baseline, after 4 weeks
The primary objective is to characterize cognitive status at baseline and after 4 weeks of the home-based stimulation intervention.
baseline, after 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modulation of gamma activity assessed with high-density EEG
Time Frame: baseline, after 4 weeks,
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,

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lucie Bréchet

Investigators

  • Principal Investigator: Lucie Bréchet, PhD, University of Geneva (UNIGE)
  • Study Chair: Paul G Unschuld, PhD, Geneva University Hospitals (HUG)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 22, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Actual)

July 15, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-D0055

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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