Mild Cognitive ImpairmentNCT05708001
Improvement of Memory in Mild Cognitive Impairment
A study testing transcranial alternating current stimulation (tACS), high-density electroencephalography (hdEEG) and Montreal Cognitive Assessment (MoCA) in people with Mild Cognitive Impairment, run by Lucie Bréchet at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- transcranial alternating current stimulation (tACS), high-density electroencephalography (hdEEG) and Montreal Cognitive Assessment (MoCA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2023to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Geneva, Campus Biotech
Geneva, 1202
Lucie Bréchet, PhD
Lucie Bréchet, PhD
About this study
Official 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
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- transcranial alternating current stimulation (tACS), high-density electroencephalography (hdEEG), Montreal Cognitive Assessment (MoCA)
- Keywords
- autobiographical memory (ABM), memory and cognition, transcranial alternating current stimulation (tACS), high-density electroencephalography (hdEEG)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Montreal Cognitive Assessment (MoCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, after 4 weeks
Secondary outcomes (1)
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.
Measured: baseline, after 4 weeks,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Feb 2023
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lucie Bréchet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lucie Bréchet, University of Geneva, Switzerland
- Investigators
- Lucie Bréchet, PhD, Principal investigator, University of Geneva (UNIGE)Paul G Unschuld, PhD, Study chair, Geneva University Hospitals (HUG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708001
- Sponsor's protocol ID
- 2021-D0055
- Status last verified
- Jul 2025
- First submitted
- 12 Jan 2023
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30902640Brechet 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.
PubMed 34485630Brechet 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.
PubMed 34093384Benussi 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.
PubMed 35607946Brechet L, Bouhour C, Rochas V, Mekrom VA, Eshmawey M, Unschuld PG. Personalized, home-based transcranial alternating current stimulation for memory improvement in mild cognitive impairment: randomized, sham-controlled clinical trial protocol. Front Aging Neurosci. 2026 Jul 31;18:1882406. doi: 10.3389/fnagi.2026.1882406. eCollection 2026.
PubMed 42602062Bouhour C, Konstantopoulou S, Piton T, Tingaud M, Mauriello C, Lory K, Unschuld PG, Brechet L. Family caregiver perspectives on administering home-based stimulation in patients with mild cognitive impairment. J Alzheimers Dis. 2026 May;111(1):249-257. doi: 10.1177/13872877261429857. Epub 2026 Mar 15.
PubMed 41834385
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05708001
- Acronym / sponsor ID
- 2021-D0055
- Conditions
- Mild Cognitive Impairment
- Keywords
- autobiographical memory (ABM), memory and cognition, transcranial alternating current stimulation (tACS), high-density electroencephalography (hdEEG)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lucie BréchetUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transcranial alternating current stimulation (tACS) | Experimental | Device: 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. |
| neurophysiological (hdEEG) | Experimental | Device: high-density electroencephalography (hdEEG)At the baseline and after 4 weeks, MCI patients will be evaluated in the laboratory using hdEEG. |
| clinical measures (MoCA) | Experimental | Diagnostic Test: Montreal Cognitive Assessment (MoCA)At the baseline and after 4 weeks, MCI patients will be evaluated in the laboratory using MoCA. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Transcranial alternating current stimulation (tACS) |
| 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. | Device | neurophysiological (hdEEG) |
| 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. | Diagnostic test | clinical measures (MoCA) |
Primary outcome
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.
1 secondary outcome
modulation of gamma activity assessed with high-density EEG
Time frame: baseline, after 4 weeks,
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Background: PubMed 30902640Brechet 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.
- Background: PubMed 34485630Brechet 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.
- Background: PubMed 34093384Brechet 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.
- Background: PubMed 35607946Benussi 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.
- Derived from this study: PubMed 42602062Brechet L, Bouhour C, Rochas V, Mekrom VA, Eshmawey M, Unschuld PG. Personalized, home-based transcranial alternating current stimulation for memory improvement in mild cognitive impairment: randomized, sham-controlled clinical trial protocol. Front Aging Neurosci. 2026 Jul 31;18:1882406. doi: 10.3389/fnagi.2026.1882406. eCollection 2026.
- Derived from this study: PubMed 41834385Bouhour C, Konstantopoulou S, Piton T, Tingaud M, Mauriello C, Lory K, Unschuld PG, Brechet L. Family caregiver perspectives on administering home-based stimulation in patients with mild cognitive impairment. J Alzheimers Dis. 2026 May;111(1):249-257. doi: 10.1177/13872877261429857. Epub 2026 Mar 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lucie Bréchet, PhD principal investigator
University of Geneva (UNIGE)
Paul G Unschuld, PhD study chair
Geneva University Hospitals (HUG)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial alternating current stimulation (tACS), high-density electroencephalography (hdEEG) and Montreal Cognitive Assessment (MoCA) in people with Mild Cognitive Impairment, run by Lucie Bréchet at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucie Bréchet, PhD (+41 22 379 08 52, lucie.brechet@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive status measured by Montreal Cognitive Assessment (MoCA) (time frame: baseline, after 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05708001, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.