NCT05710549

Brief Summary

The overall objective of this project is to characterize the spatiotemporal dynamics of brain oscillations underpinning autobiographical memory (ABM) and the modulation of the memory network using non-invasive brain stimulation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Apr 2022Aug 2027

Study Start

First participant enrolled

April 25, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

5 years

First QC Date

January 12, 2023

Last Update Submit

July 9, 2025

Conditions

Keywords

autobiographical memory (ABM)high-density electroencephalography (EEG)magnetic resonance imaging (MRI)non-invasive brain stimulation (NIBS)transcranial alternating current stimulation (tACS)

Outcome Measures

Primary Outcomes (2)

  • Spatiotemporal dynamic changes measured with electroencephalography (hdEEG)

    Changes in spatiotemporal dynamics in different frequency bands (theta, alpha, beta, gamma) will be assessed with hdEEG

    up to 30 minutes

  • Cognitive Assessment

    The Montreal Cognitive Assessment (MOCA) will be administered to characterize the cognitive status

    baseline

Study Arms (2)

neurophysiological measurements

EXPERIMENTAL

40 cognitively-unimpaired healthy young adults (age 18-35 years old), 40 cognitively-unimpaired healthy older adults (age 55+ years old), and 40 age-matched patients with mild cognitive impairment (MCI) (age 55+ years old) will be assessed using high-density electroencephalography (hdEEG) to characterize the spatiotemporal dynamics of brain oscillations during personalized, autobiographical memory (ABM) tasks.

Device: high-density electroencephalography (hdEEG)

neuropsychological examination

EXPERIMENTAL

40 MCI patients (age 55+ years old) will undergo 20min multi-channel protocols of transcranial alternating current stimulation; tACS (either gamma, beta, or ActiSham stimulation randomized across the three laboratory sessions) to modify cognitive functioning (MoCA score), and oscillatory brain activity during performing personalized, autobiographical memory (ABM) tasks and resting-state EEG.

Device: Transcranial alternating current stimulation (tACS)

Interventions

EEG will be recorded with a 257-channel EEG system (Geodesic Sensor Net, MegStim). An EEG net is applied at once on the head with evenly spaced sensors that provide full scalp coverage, including the cheek, Ag/Ag-Cl electrodes that are interconnected by thin rubber bands and contain small sponges soaked with saline water that touches the participant's scalp surface directly. Net application takes about 10 min to derive impedances to \<30 kOhms. EEG is recorded with 1 kHz and band-pass filtered between 0.1-200 Hz. Vertex electrode Cz is used as an acquisition reference.

neurophysiological measurements

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.

neuropsychological examination

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cognitively-Unimpaired Younger and Older Adults
  • Age 18 to 35 years old (younger adults)
  • Age 55+ years old (older adults)
  • without any cognitive impairment (based on the Montreal Cognitive Assessment: MoCA)
  • willing and capable to give informed consent for participation in the study after it has been thoroughly explained able
  • willing to comply with all study requirements informed consent form was signed
  • Mild Cognitive Impairment (MCI) patients
  • Age 55+ years old
  • Clinical Diagnosis of MCI
  • Confirmation of diagnosis will be made by the study MD based on a holistic consideration of the participant's cognitive evaluation and history
  • Mini-Mental State Examination (MMSE) ≥ 18 (Mild AD ≥ 21)
  • CDR ≥ .5
  • Demonstration or history of autobiographical memory impairments
  • On a stable dose of medications for memory loss including cholinesterase inhibitors (e.g. donepezil, rivastigmine) or memantine as defined as 6 consecutive weeks of treatment at an unchanging dose
  • Minimum of completed 8th-grade education
  • +2 more criteria

You may not qualify if:

  • Cognitively-Unimpaired Younger and Older Adults
  • any cognitive impairment captured by the Montreal Cognitive Assessment (MoCA) - score \< 26
  • major psychiatric co-morbidity including major depressive disorder, schizophrenia, or psychosis
  • blindness or other disabilities that prevent task performance
  • Contraindication for undergoing MRI
  • 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)
  • Mild Cognitive Impairment (MCI) patients
  • Age \< 55 years old
  • Any current diagnosis of a major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major 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, or immediate (1st-degree relative) family history of epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
  • Any unstable medical condition or chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.) or study complication
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Geneva, Campus Biotech

Geneva, Canton of Geneva, 1202, Switzerland

RECRUITING

Related Publications (3)

  • 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: 30902640BACKGROUND
  • Roehri N, Brechet L, Seeber M, Pascual-Leone A, Michel CM. Phase-Amplitude Coupling and Phase Synchronization Between Medial Temporal, Frontal and Posterior Brain Regions Support Episodic Autobiographical Memory Recall. Brain Topogr. 2022 Mar;35(2):191-206. doi: 10.1007/s10548-022-00890-4. Epub 2022 Jan 26.

    PMID: 35080692BACKGROUND
  • Michel CM, He B. EEG source localization. Handb Clin Neurol. 2019;160:85-101. doi: 10.1016/B978-0-444-64032-1.00006-0.

    PMID: 31277878BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer DiseaseMemory Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Lucie Bréchet, PhD

    University of Geneva (UNIGE)

    PRINCIPAL INVESTIGATOR
  • Paul G Unschuld, Prof. MD

    Geneva University Hospitals (HUG)

    STUDY CHAIR

Central Study Contacts

Lucie Bréchet, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 12, 2023

First Posted

February 2, 2023

Study Start

April 25, 2022

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

July 15, 2025

Record last verified: 2025-07

Locations