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CompletedNCT04785053MemStim-labUpdated Jun 26, 2024

Memory Functions in Mild Alzheimer's Disease

An interventional study of transcranial alternating current stimulation (tACS) in Alzheimer Disease, sponsored by Hebrew SeniorLife. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-26.

Sponsored by Hebrew SeniorLife · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Sep 2023, 3 years ago, and no results have been posted to the registry.
  • Registered 8 months after the study started (first participant enrolled Jun 2020, registered Feb 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

The overall objective of this project is to examine the effects of non-invasive brain stimulation on episodic memory performance

Read the detailed description

A group of 20 cognitively intact younger participants (age 21-35), a group of 20 cognitively intact older participants (age 55+) and an age-matched group of 20 MCI/mild AD participants will be enrolled in the brain stimulation study with behavioral assessments at baseline and post-intervention. All participants will perform a laboratory-based memory task and an autobiographical memory task, followed by the autobiographical interview after the tACS intervention. Each participant will undergo three experimental sessions, applying 20-minute gamma tACS stimulation, theta tACS stimulation or an active sham (control) to the left angular gyrus. Before, during, and after the brain stimulation scalp high-density 257-channels EEG will be recorded to characterize and differentiate brain activity and regional interactions in the three independent groups.

02

Conditions studied

  • Alzheimer Disease

Browse trials for

Keywords

  • non-invasive brain stimulation (NIBS)
  • transcranial alternating current stimulation (tACS)
  • electroencephalography (EEG)
  • autobiographical memory (ABM)
03

In context

Alzheimer Disease

3,766 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.

This study's enrollment of 34 is below the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Hebrew SeniorLife is the lead sponsor of 37 studies on the registry; 6 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Healthy young participants:

  • age 21-35
  • without any cognitive impairment (based on the Montreal Cognitive Assessment: MoCA - in-person screening or Telephone Interview of Cognitive Status: TICS - phone screening)
  • willing and capable to give informed consent for the participation in the study after it has been thoroughly explained able and willing to comply with all study requirements informed consent form (ICF) form was signed
  • Understanding of the ICF will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form . Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.

Healthy older participants:

  • age 55+ without any cognitive impairment (based in MoCA or TICS)
  • willing and capable to give informed consent for the participation in the study after it has been thoroughly explained able and willing to comply with all study requirements informed consent form was signed
  • Understanding of the ICF will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.

Older MCI/mild AD participants:

  • age 55+
  • who have been diagnosed with cognitive impairment (based in MoCA or TICS and Clinical Dementia Rating: CDR)
  • willing and capable to give informed consent for the participation in the study after it has been thoroughly explained - note that to ensure this in the case for the MCI/AD 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
  • Understanding of the ICF will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.

Exclusion criteria

Exclusion Criteria:

Healthy young participants:

  • potentially eligible individuals will complete the Telephone Interview of Cognitive Status (TICS) score of ≤31 or 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
  • 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

Healthy older participants:

  • potentially eligible individuals will complete the Telephone Interview of Cognitive Status (TICS) with a score of ≤31 or 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
  • 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

Older MCI/mild AD participants:

  • cut off of MOCA score \<18 will be applied
  • major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
  • blindness or other disabilities that prevent task performance
  • contraindications to tACS, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuro-active 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    Healthy young participants

    a group of 20 cognitively intact younger participants (age 21-35)

    Device: transcranial alternating current stimulation (tACS)

  • Active comparator
    Healthy older participants

    A group of 20 cognitively intact older participants (age 55+)

    Device: transcranial alternating current stimulation (tACS)

  • Active comparator
    Older MCI/mild AD participants

    A group of 20 cognitively impaired older participants (age 55+)

    Device: transcranial alternating current stimulation (tACS)

Interventions

  • Devicetranscranial alternating current stimulation (tACS)

    The tACS intervention (gamma stimulation, theta stimulation and active sham condition) will be administered to the participants over three visits that will be completed within one of the working days (Mon-Fri) at approximately the same time of day for all participants. Participants will be randomized and blinded to the tACS treatment.

    Also known as: non-invasive brain stimulation

06

What researchers measure

Primary outcomes

  1. Spatiotemporal dynamic changes measured with electroencephalography (EEG)

    Changes in spatiotemporal dynamics in different frequency bands (theta, alpha, beta, gamma) will be assessed with high density - hdEEG after tACS intervention (gamma, theta, sham)

    Time frame: 3 lab-visits will occur at least 2 days apart within one month

  2. Behavioral performance measured with Montreal Cognitive Assessment (MoCA)

    Changes in behavioral performance will be assessed using Montreal Cognitive Assessment (MoCA) after tACS intervention (gamma, theta, sham)

    Time frame: 3 lab-visits will occur at least 2 days apart within one month

07

Study locations

1 site
  • Hinda and Arthur Marcus Institute for Aging Research
    Boston, Massachusetts 02131, United States
08

References and documents

Publications

  • Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10. PubMed 25797650 ↗
  • Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19. PubMed 28709880 ↗
  • 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. PubMed 30902640 ↗
  • Ruffini G, Fox MD, Ripolles O, Miranda PC, Pascual-Leone A. Optimization of multifocal transcranial current stimulation for weighted cortical pattern targeting from realistic modeling of electric fields. Neuroimage. 2014 Apr 1;89:216-25. doi: 10.1016/j.neuroimage.2013.12.002. Epub 2013 Dec 15. PubMed 24345389 ↗
  • Michel CM, He B. EEG source localization. Handb Clin Neurol. 2019;160:85-101. doi: 10.1016/B978-0-444-64032-1.00006-0. PubMed 31277878 ↗
  • Michel CM, Pascual-Leone A. Predicting antidepressant response by electroencephalography. Nat Biotechnol. 2020 Apr;38(4):417-419. doi: 10.1038/s41587-020-0476-5. No abstract available. PubMed 32265551 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2020 to primary completion in Sep 2023, 39 months.

Of 806 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's 39 months is above that.

Counting every sponsor, half of 874 studies reached it within 31 months; a quarter within 15 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2021
First posted
Mar 5, 2021
StartActual
Jun 22, 2020
Primary completionActual
Sep 30, 2023
CompletionActual
Sep 30, 2023
Last update
Jun 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04785053
Lead sponsor
Hebrew SeniorLife
Responsible party
Alvaro Pascual-Leone (Senior Scientist, Hebrew SeniorLife) — Principal investigator
First posted
Mar 5, 2021
Start date
Jun 22, 2020
Primary completion
Sep 30, 2023
Completion
Sep 30, 2023
Last update
Jun 26, 2024

Study contacts

Alvaro Pascual-Leone, Dr.
principal investigator · Hinda and Arthur Marcus Institute for Aging Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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