Understanding Brain Mechanisms Involved in Autobiographical Memory
1 other identifier
interventional
120
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2022
CompletedFirst Submitted
Initial submission to the registry
January 12, 2023
CompletedFirst Posted
Study publicly available on registry
February 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
July 15, 2025
July 1, 2025
5 years
January 12, 2023
July 9, 2025
Conditions
Keywords
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
EXPERIMENTAL40 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.
neuropsychological examination
EXPERIMENTAL40 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.
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.
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.
Eligibility Criteria
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
- Lucie Bréchetlead
Study Sites (1)
University of Geneva, Campus Biotech
Geneva, Canton of Geneva, 1202, Switzerland
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: 30902640BACKGROUNDRoehri 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: 35080692BACKGROUNDMichel 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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lucie Bréchet, PhD
University of Geneva (UNIGE)
- STUDY CHAIR
Paul G Unschuld, Prof. MD
Geneva University Hospitals (HUG)
Central Study Contacts
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