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Memory Functions in Mild Alzheimer's Disease (MemStim-lab)

Primary Purpose

Alzheimer Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcranial alternating current stimulation (tACS)
Sponsored by
Hebrew SeniorLife
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer Disease focused on measuring non-invasive brain stimulation (NIBS), transcranial alternating current stimulation (tACS), electroencephalography (EEG), autobiographical memory (ABM)

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

Healthy young participants:

  • potentially eligible individuals will complete the Telephone Interview of Cognitive Status (TICS) score of โ‰ค31 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 โ‰ค31 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

Sites / Locations

  • Hinda and Arthur Marcus Institute for Aging Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Healthy young participants

Healthy older participants

Older MCI/mild AD participants

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Full Information

First Posted
February 26, 2021
Last Updated
September 20, 2023
Sponsor
Hebrew SeniorLife
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1. Study Identification

Unique Protocol Identification Number
NCT04785053
Brief Title
Memory Functions in Mild Alzheimer's Disease
Acronym
MemStim-lab
Official Title
Improving Memory Functions in Mild Alzheimer's Disease by Transcranial Alternating Current Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebrew SeniorLife

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
non-invasive brain stimulation (NIBS), transcranial alternating current stimulation (tACS), electroencephalography (EEG), autobiographical memory (ABM)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants will be randomized to the tACS treatment (target tACS, minimum 2 days later an active sham control).
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy young participants
Arm Type
Active Comparator
Arm Description
a group of 20 cognitively intact younger participants (age 21-35)
Arm Title
Healthy older participants
Arm Type
Active Comparator
Arm Description
A group of 20 cognitively intact older participants (age 55+)
Arm Title
Older MCI/mild AD participants
Arm Type
Active Comparator
Arm Description
A group of 20 cognitively impaired older participants (age 55+)
Intervention Type
Device
Intervention Name(s)
transcranial alternating current stimulation (tACS)
Other Intervention Name(s)
non-invasive brain stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spatiotemporal dynamic changes measured with electroencephalography (EEG)
Description
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
Title
Behavioral performance measured with Montreal Cognitive Assessment (MoCA)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Healthy young participants: potentially eligible individuals will complete the Telephone Interview of Cognitive Status (TICS) score of โ‰ค31 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 โ‰ค31 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alvaro Pascual-Leone, Dr.
Organizational Affiliation
Hinda and Arthur Marcus Institute for Aging Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hinda and Arthur Marcus Institute for Aging Research
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25797650
Citation
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.
Results Reference
background
PubMed Identifier
28709880
Citation
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.
Results Reference
background
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
result
PubMed Identifier
24345389
Citation
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.
Results Reference
result
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
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PubMed Identifier
32265551
Citation
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.
Results Reference
result

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Memory Functions in Mild Alzheimer's Disease

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