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NCT Number: NCT05708001

Improvement of Memory in Mild Cognitive Impairment

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.

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Geneva, Campus Biotech

Geneva, 1202, Switzerland

Location status: Recruiting

Location contact

Lucie Bréchet, PhD

CONTACT

Lucie Bréchet, PhD

PRINCIPAL_INVESTIGATOR

Paul G Unschuld, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lucie Bréchet, PhD

CONTACT

[email protected]

+41 22 379 08 52

Sponsors and collaborators

Lead sponsor

Lucie Bréchet

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 1, 2023
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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