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Improvement of Memory in Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

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

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring autobiographical memory (ABM), memory and cognition, transcranial alternating current stimulation (tACS), high-density electroencephalography (hdEEG)

Eligibility Criteria

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

Inclusion Criteria: 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. Giovanni Frisoni, 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 Exclusion Criteria: 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 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

Sites / Locations

  • University of Geneva, Campus BiotechRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Transcranial alternating current stimulation (tACS)

neurophysiological and clinical measures

Arm Description

The randomized, sham-controlled, parallel-arm, double-blind clinical trial will include 12 weeks of daily, home-based stimulation sessions. MCI patients will be randomly assigned to the active or sham group.

At the baseline, after the first 4 weeks, and at the end of 12 weeks, MCI patients will be evaluated in the laboratory using MoCA and hdEEG.

Outcomes

Primary Outcome Measures

cognitive status measured by Montreal Cognitive Assessment (MoCA)
The primary objective is to characterize cognitive status at baseline, after 4 weeks and after 12 weeks of the home-based stimulation intervention.

Secondary Outcome Measures

modulation of gamma activity assessed with high-density EEG
The secondary objective is to assess with hdEEG any changes in gamma power at baseline, after 4 weeks and after 12 weeks of the home-based stimulation intervention.

Full Information

First Posted
January 12, 2023
Last Updated
January 22, 2023
Sponsor
Prof. Christoph M. Michel
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1. Study Identification

Unique Protocol Identification Number
NCT05708001
Brief Title
Improvement of Memory in Mild Cognitive Impairment
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (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
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
autobiographical memory (ABM), memory and cognition, transcranial alternating current stimulation (tACS), high-density electroencephalography (hdEEG)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial alternating current stimulation (tACS)
Arm Type
Experimental
Arm Description
The randomized, sham-controlled, parallel-arm, double-blind clinical trial will include 12 weeks of daily, home-based stimulation sessions. MCI patients will be randomly assigned to the active or sham group.
Arm Title
neurophysiological and clinical measures
Arm Type
Experimental
Arm Description
At the baseline, after the first 4 weeks, and at the end of 12 weeks, MCI patients will be evaluated in the laboratory using MoCA and hdEEG.
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. 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.
Intervention Type
Device
Intervention Name(s)
high-density electroencephalography (hdEEG)
Intervention Description
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.
Primary Outcome Measure Information:
Title
cognitive status measured by Montreal Cognitive Assessment (MoCA)
Description
The primary objective is to characterize cognitive status at baseline, after 4 weeks and after 12 weeks of the home-based stimulation intervention.
Time Frame
baseline, after 4 weeks, after 12 weeks
Secondary Outcome Measure Information:
Title
modulation of gamma activity assessed with high-density EEG
Description
The secondary objective is to assess with hdEEG any changes in gamma power at baseline, after 4 weeks and after 12 weeks of the home-based stimulation intervention.
Time Frame
baseline, after 4 weeks, after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Giovanni Frisoni, 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 Exclusion Criteria: 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 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
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
34485630
Citation
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.
Results Reference
background
PubMed Identifier
34093384
Citation
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.
Results Reference
background
PubMed Identifier
35607946
Citation
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.
Results Reference
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Improvement of Memory in Mild Cognitive Impairment

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