Memory Functions in Mild Alzheimer's Disease

NCT04785053 | Completed FDA Device

• 1 other identifier: Pro00044505
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

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

• 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)

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

Study Arms (3)

Healthy young participants

ACTIVE COMPARATOR

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

Device: transcranial alternating current stimulation (tACS)

Healthy older participants

ACTIVE COMPARATOR

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

Device: transcranial alternating current stimulation (tACS)

Older MCI/mild AD participants

ACTIVE COMPARATOR

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

Device: transcranial alternating current stimulation (tACS)

Interventions

transcranial alternating current stimulation (tACS) DEVICE

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

Healthy older participants; Healthy young participants; Older MCI/mild AD participants

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebrew SeniorLife: lead

Study Sites (1)

Hinda and Arthur Marcus Institute for Aging Research

Boston, Massachusetts, 02131, United States

Location

Related Publications (6)

• 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.

  PMID: 25797650 BACKGROUND

• 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.

  PMID: 28709880 BACKGROUND

• 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.

  PMID: 30902640 RESULT

• 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.

  PMID: 24345389 RESULT

• Michel CM, He B. EEG source localization. Handb Clin Neurol. 2019;160:85-101. doi: 10.1016/B978-0-444-64032-1.00006-0.

  PMID: 31277878 RESULT

• 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.

  PMID: 32265551 RESULT

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Alvaro Pascual-Leone, Dr.

  Hinda and Arthur Marcus Institute for Aging Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomized to the tACS treatment (target tACS, minimum 2 days later an active sham control).
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 5, 2021
• Study Start: June 22, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)