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Understanding Brain Mechanisms Involved in Autobiographical Memory

Primary Purpose

Mild Cognitive Impairment, Alzheimer Disease, Memory Loss

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
high-density electroencephalography (hdEEG)
Transcranial alternating current stimulation (tACS)
Sponsored by
Prof. Christoph M. Michel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mild Cognitive Impairment focused on measuring autobiographical memory (ABM), high-density electroencephalography (EEG), magnetic resonance imaging (MRI), non-invasive brain stimulation (NIBS), transcranial alternating current stimulation (tACS)

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 willing and capable to give informed consent for participation in the study after it has been thoroughly explained - note that to ensure this in the case of the MCI participants, a cut-off of MOCA score >18 will be applied able and willing to comply with all study requirements informed consent form was signed Exclusion Criteria: 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 contraindications to tACS, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuroactive drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp 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 devices such as a pacemaker, medication pump, nerve stimulator, TENS unit, ventriculoperitoneal shunt unless cleared by the responsible covering MD

Sites / Locations

  • University of Geneva, Campus BiotechRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

neurophysiological measurements

neuropsychological examination

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Spatiotemporal dynamic changes measured with electroencephalography (hdEEG)
Changes in spatiotemporal dynamics in different frequency bands (theta, alpha, beta, gamma) will be assessed with hdEEG
Cognitive Assessment
The Montreal Cognitive Assessment (MOCA) will be administered to characterize the cognitive status after 20 minutes tACS

Secondary Outcome Measures

Full Information

First Posted
January 12, 2023
Last Updated
January 24, 2023
Sponsor
Prof. Christoph M. Michel
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1. Study Identification

Unique Protocol Identification Number
NCT05710549
Brief Title
Understanding Brain Mechanisms Involved in Autobiographical Memory
Official Title
Understanding Brain Mechanisms Involved in Autobiographical Memory Using High-density Electroencephalography and Transcranial Alternating Current Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Christoph M. Michel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Accumulating evidence suggests that activity in distributed networks supporting ABM is altered even decades before the expected onset of clinical symptoms in Alzheimer's disease (AD). Robust network alterations associated with age-related memory and cognitive decline have been linked to abnormal oscillatory brain rhythmic activity and functional dysconnectivity. However, the detailed neural mechanisms are still poorly understood. The investigators propose to precisely characterize the underlying neurophysiological mechanisms that lead to behavioral and cognitive disturbances in ABM of MCI patients. Specifically, hdEEG will be used to characterize the sources and spatiotemporal dynamics of the neuronal activity involved in the ABM network of 40 mild cognitive impairment (MCI) patients and compare it to 40 age-matched, older healthy participants and 40 healthy young participants. The investigators will then apply non-invasive brain stimulation in the form of transcranial alternating current stimulation (tACS) to gain novel insights into the causal role of brain oscillations in the ABM network of MCI patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Alzheimer Disease, Memory Loss
Keywords
autobiographical memory (ABM), high-density electroencephalography (EEG), magnetic resonance imaging (MRI), non-invasive brain stimulation (NIBS), transcranial alternating current stimulation (tACS)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
neurophysiological measurements
Arm Type
Experimental
Arm Description
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.
Arm Title
neuropsychological examination
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
high-density electroencephalography (hdEEG)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial alternating current stimulation (tACS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spatiotemporal dynamic changes measured with electroencephalography (hdEEG)
Description
Changes in spatiotemporal dynamics in different frequency bands (theta, alpha, beta, gamma) will be assessed with hdEEG
Time Frame
after 20 minutes of personalized memory task
Title
Cognitive Assessment
Description
The Montreal Cognitive Assessment (MOCA) will be administered to characterize the cognitive status after 20 minutes tACS
Time Frame
after 20 minutes of tACS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 willing and capable to give informed consent for participation in the study after it has been thoroughly explained - note that to ensure this in the case of the MCI participants, a cut-off of MOCA score >18 will be applied able and willing to comply with all study requirements informed consent form was signed Exclusion Criteria: 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 contraindications to tACS, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuroactive drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp 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 devices such as a pacemaker, medication pump, nerve stimulator, TENS unit, ventriculoperitoneal shunt unless cleared by the responsible covering MD
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucie Bréchet, PhD
Phone
+41 22 379 08 52
Email
lucie.brechet@unige.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Michel, PhD
Organizational Affiliation
University of Geneva (UNIGE)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giovanni Frisoni, PhD
Organizational Affiliation
Geneva University Hospitals (HUG)
Official's Role
Study Chair
Facility Information:
Facility Name
University of Geneva, Campus Biotech
City
Geneva
ZIP/Postal Code
1202
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie Bréchet, PhD
First Name & Middle Initial & Last Name & Degree
Christoph M Michel, PhD
First Name & Middle Initial & Last Name & Degree
Lucie Bréchet, PhD
First Name & Middle Initial & Last Name & Degree
Giovanni Frisoni, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
30902640
Citation
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.
Results Reference
background
PubMed Identifier
35080692
Citation
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.
Results Reference
background
PubMed Identifier
31277878
Citation
Michel CM, He B. EEG source localization. Handb Clin Neurol. 2019;160:85-101. doi: 10.1016/B978-0-444-64032-1.00006-0.
Results Reference
background

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Understanding Brain Mechanisms Involved in Autobiographical Memory

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