Improvement of Memory in Mild Cognitive Impairment

NCT05708001 | Recruiting DMC

• 1 other identifier: 2021-D0055
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment

Keywords

autobiographical memory (ABM); memory and cognition; transcranial alternating current stimulation (tACS); high-density electroencephalography (hdEEG)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• modulation of gamma activity assessed with high-density EEG

  baseline, after 4 weeks,

Study Arms (3)

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.

Device: transcranial alternating current stimulation (tACS)

neurophysiological (hdEEG)

EXPERIMENTAL

At the baseline and after 4 weeks, MCI patients will be evaluated in the laboratory using hdEEG.

Device: high-density electroencephalography (hdEEG)

clinical measures (MoCA)

EXPERIMENTAL

At the baseline and after 4 weeks, MCI patients will be evaluated in the laboratory using MoCA.

Diagnostic Test: Montreal Cognitive Assessment (MoCA)

Interventions

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.

Transcranial alternating current stimulation (tACS)

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.

neurophysiological (hdEEG)

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.

clinical measures (MoCA)

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lucie Bréchet: lead

Study Sites (1)

University of Geneva, Campus Biotech

Geneva, 1202, Switzerland

RECRUITING

Related Publications (4)

• 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.

  PMID: 30902640 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.

  PMID: 34485630 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.

  PMID: 34093384 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.

  PMID: 35607946 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Lucie Bréchet, PhD

  University of Geneva (UNIGE)

  PRINCIPAL INVESTIGATOR

• Paul G Unschuld, PhD

  Geneva University Hospitals (HUG)

  STUDY CHAIR

Central Study Contacts

Lucie Bréchet, PhD

CONTACT

+41 22 379 08 52; lucie.brechet@unige.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 1, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

CH (1)