Memory Enhancement Using Transcranial Alternating Current Stimulation (Memento)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Willem de Haan, dr.
- Phone Number: +31 (0)20 444 0722
- Email: w.dehaan@amsterdamumc.nl
Study Locations
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North Holland
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Amsterdam, North Holland, Netherlands, 1081HV
- Amsterdam UMC, The Netherlands
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Recent (not more than 6 months ago) amnestic MCI diagnosis, which consensus is obtained in a multidisciplinary meeting after an extended multidisciplinary test battery at the memory clinic, including confirmation of AD pathology with cerebrospinal fluid biomarkers: abnormal p-tau/Aβ42 ratio of > 0.023
Exclusion Criteria:
- Suffering from serious neurological, psychiatric or somatic comorbidity
- Suffering from epileptic seizures or severe claustrophobia
- Intensive use of psychoactive medication
- Having a cardiac pacemaker, internal cardiac defibrillator or other intracorporeal device that interferes with MEG recordings
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Active tACS
Gamma (40 Hz) tACS at the precuneus region
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40 Hz tACS applied at a current of 3.2 milliampere peak-to-peak using a NuroStym transcranial electrical stimulation (tES) system of NeuroDevice for four times 12 minutes (48 minutes in total) at the Pz (according to the 10-20 international EEG coordinates)
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Sham Comparator: Sham tACS
Sham tACS at the precuneus region
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Sham tACS applied with no effective stimulation between the ramp-up and ramp-down of the current using a NuroStym tES system of NeuroDevice for four times 12 minutes (48 minutes in total) at the Pz (according to the 10-20 international EEG coordinates)
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Rey Auditory Verbal Learning test scores
Time Frame: Immediately before and after intervention
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The Rey Auditory Verbal Learning (RAVL) test evaluates verbal episodic memory and is designed as a list-learning paradigm in which the subject hears a list of 15 nouns.
The participant is asked to recall as many words from the list as possible after each of 5 repetitions of free-recall (total recall), and 15 minutes after an interference trial (long delayed recall).
Scores range from 0 to 75 (total recall) and 0 to 15 (long delayed recall), with higher scores meaning a better outcome.
An increase in RAVL test (total and long delayed recall) after active but not sham tACS is expected.
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Immediately before and after intervention
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Change in Face-Name Association Task scores
Time Frame: Immediately before and after intervention
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The Face-Name Association Task assesses associative episodic memory and is a computer paradigm consisting of an encoding and a retrieval phase of face-name pairs.
During the encoding phase, participants are instructed to remember a set of 12 faces and names they are paired.
In two additional learning trials, participants are shown the previously learned faces and are asked to recall the correct name associated with each face (inital recognition).
This recall of the correct name associated with a learned face is repeated 5 minutes after the learning trials during the retrieval phase (associative recognition).
Scores range from 0 to 24 (inital recognition) and 0 to 12 (associative recognition), with higher scores meaning a better outcome.
An increase in FNAT score (initial and associative recognition) after active but not sham tACS is expected.
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Immediately before and after intervention
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in spectral source space resting-state MEG (relative power)
Time Frame: Immediately before and after intervention
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Change in relative power will be used, expecting an increase in relative power in higher alpha, beta and gamma bands and decrease in relative power in theta band after active but not sham tACS.
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Immediately before and after intervention
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Change in spectral source space resting-state MEG (posterior peak frequency)
Time Frame: Immediately before and after intervention
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Change in posterior peak frequency will be used, expecting an increase in posterior peak frequency after active but not sham tACS.
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Immediately before and after intervention
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Change in functional connectivity source space resting-state MEG (AEC-c)
Time Frame: Immediately before and after intervention
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Change in corrected amplitude envelope correlation (AEC-c) will be used, expecting an increase in AEC-c in higher alpha, beta and gamma bands after active but not sham tACS.
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Immediately before and after intervention
|
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Change in functional connectivity source space resting-state MEG (PLI)
Time Frame: Immediately before and after intervention
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Change in phase lag index (PLI) will be used, expecting a decrease in PLI in theta band after active but not sham tACS.
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Immediately before and after intervention
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Change in source space resting-state MEG network structure (MST variables)
Time Frame: Immediately before and after intervention
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Change in graph theory parameters will be used as a measure of global network structure.
Restoration of overall network configuration (expressed by shift of multiple Minimum spanning tree (MST) parameters towards healthy state, e.g.
stronger hierarchy) after active but not sham tACS is expected.
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Immediately before and after intervention
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Change in source space resting-state MEG network structure (clustering coefficient and path length)
Time Frame: Immediately before and after intervention
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Change in graph theory parameters will be used as a measure of global network structure.
Preserved small-world configuration (shift of small world index (clustering coefficient/path length) towards less random topology) after active but not sham tACS is expected.
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Immediately before and after intervention
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Change in source space resting-state MEG network structure (modulatory index, degree and eigenvector centrality)
Time Frame: Immediately before and after intervention
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Change in graph theory parameters will be used as a measure of mesoscale network structure (modularory measures) and nodal characteristics (degree and eigenvector centrality).
Restoration of hub disruption (stronger modularity index, increase in degree and eigenvector centrality) of precuneus-posterior cingulate and medial temporal lobe after active but not sham tACS is expected.
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Immediately before and after intervention
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Willem de Haan, dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Publications and helpful links
General Publications
- Benussi A, Cantoni V, Cotelli MS, Cotelli M, Brattini C, Datta A, Thomas C, Santarnecchi E, Pascual-Leone A, Borroni B. Exposure to gamma tACS in Alzheimer's disease: A randomized, double-blind, sham-controlled, crossover, pilot study. Brain Stimul. 2021 May-Jun;14(3):531-540. doi: 10.1016/j.brs.2021.03.007. Epub 2021 Mar 21.
- 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.
- Grover S, Fayzullina R, Bullard BM, Levina V, Reinhart RMG. A meta-analysis suggests that tACS improves cognition in healthy, aging, and psychiatric populations. Sci Transl Med. 2023 May 24;15(697):eabo2044. doi: 10.1126/scitranslmed.abo2044. Epub 2023 May 24.
- Maestu F, de Haan W, Busche MA, DeFelipe J. Neuronal excitation/inhibition imbalance: core element of a translational perspective on Alzheimer pathophysiology. Ageing Res Rev. 2021 Aug;69:101372. doi: 10.1016/j.arr.2021.101372. Epub 2021 May 21.
- Palop JJ, Mucke L. Network abnormalities and interneuron dysfunction in Alzheimer disease. Nat Rev Neurosci. 2016 Dec;17(12):777-792. doi: 10.1038/nrn.2016.141. Epub 2016 Nov 10.
- Iaccarino HF, Singer AC, Martorell AJ, Rudenko A, Gao F, Gillingham TZ, Mathys H, Seo J, Kritskiy O, Abdurrob F, Adaikkan C, Canter RG, Rueda R, Brown EN, Boyden ES, Tsai LH. Gamma frequency entrainment attenuates amyloid load and modifies microglia. Nature. 2016 Dec 7;540(7632):230-235. doi: 10.1038/nature20587.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 20212222
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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