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Home-based Brain Stimulation for Memory (MemStim-home)

Primary Purpose

Alzheimer Disease, Memory Loss

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcranial alternating current stimulation (tACS)

About this trial

This is an interventional basic science trial for Alzheimer Disease focused on measuring alzheimer disease, memory and cognition, autobiographical memory, transcranial alternating current stimulation (tACS), guided high-density electroencephalography (hdEEG)

Eligibility Criteria

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

Inclusion Criteria:

Participants (Ps)

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
an informed consent form was signed
able to read, write, and communicate in English
able to identify an eligible administrator to participate with them in the study

Administrators (As)

at least 21 years of age
able to read, write, and communicate in English
self-reported computer proficiency and willingness to learn how to use tACS as defined by "yes" answers to the questions "Do you feel comfortable using a computer?" and "Are you willing to be the primary caregiver for a participant and learn how to administer tACS?"
stated availability during weekdays throughout the study period to administer tACS to the Ps

Exclusion Criteria:

Participants (Ps)

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.)
the presence of any active dermatological condition, such as eczema, on the scalp a score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person screen
an inability to understand study procedures following review of the Informed Consent form
Understanding 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 (see attached). Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator

Administrators (As)

mild cognitive impairment defined by a MoCA score ≤26 during the in-person screen
insufficient understanding of study procedures following review of the Informed Consent form
Understanding 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 (see attached). Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
poor eyesight, severe arthritis in the hands, pain, deformity or other condition that interferes with successful administration of tACS

Sites / Locations

Hinda and Arthur Marcus Institute for Aging Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial alternating current stimulation (tACS)

Arm Description

Participants (Ps) will undergo 20min of daily home-based tACS intervention at 40Hz over the left angular gyrus for 4 weeks by trained administrators (As) (phase 1). In case of cognitive and mental improvement participants will undergo further 10 weeks of 20 minutes session of tACS daily (phase 2). Additionally, those P/A pairs who completed the 14 weeks of home-based tACS intervention and express an interest in an open label extension may be enrolled in further 34 weeks of 20 minutes tACS sessions.

Outcomes

Primary Outcome Measures

Clinical Evaluation and Cognitive Assessment

a trained clinician will administer the Montreal Cognitive Assessment (MOCA) to characterize cognitive status and the level of dementia

Electroencephalography (EEG) measures

High-density EEG (257 channels) will be recorded before and after the tACS intervention and changes in spatiotemporal dynamics in different frequency bands (theta, alpha, beta, gamma) will be assessed

Secondary Outcome Measures

Full Information

NCT ID

NCT04783350

First Posted

February 26, 2021

Last Updated

September 20, 2023

Sponsor

Hebrew SeniorLife

1. Study Identification

Unique Protocol Identification Number

NCT04783350

Brief Title

Home-based Brain Stimulation for Memory

Acronym

MemStim-home

Official Title

Home-based Transcranial Alternating Current Stimulation (tACS) for Older Adults at Risk of Memory Decline

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 6, 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

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The proposed project aims to systematically examine the feasibility of remote, caregiver-led tACS for older adults who are vulnerable to memory decline.

Detailed Description

This is a feasibility study, which will include older adult participants (Ps) with memory deficits together with willing and able administrators (As) to administer tACS to the participants. This study will include 20 older Ps and 20 As to assess the feasibility of deploying home-based tACS in larger clinical trials, and to prepare for the development and implementation of such trials. The proposed project will systematically examine the feasibility of remote, caregiver-led tACS for older adults who are vulnerable to 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 of tACS as a part of memory decline prevention and treatment for older adults who have more difficulty reaching a clinic for treatment due to disability or who live more remotely.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease, Memory Loss

Keywords

alzheimer disease, memory and cognition, autobiographical memory, transcranial alternating current stimulation (tACS), guided high-density electroencephalography (hdEEG)

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transcranial alternating current stimulation (tACS)

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Transcranial alternating current stimulation (tACS)

Other Intervention Name(s)

non-invasive brain stimulation

Intervention Description

tACS will be administered to the left angular gyrus at gamma frequency to improve cognitive functioning (MoCA score) and resting-state EEG signatures.

Primary Outcome Measure Information:

Title

Clinical Evaluation and Cognitive Assessment

Description

a trained clinician will administer the Montreal Cognitive Assessment (MOCA) to characterize cognitive status and the level of dementia

Time Frame

48 weeks

Title

Electroencephalography (EEG) measures

Description

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants (Ps) 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 an informed consent form was signed able to read, write, and communicate in English able to identify an eligible administrator to participate with them in the study Administrators (As) at least 21 years of age able to read, write, and communicate in English self-reported computer proficiency and willingness to learn how to use tACS as defined by "yes" answers to the questions "Do you feel comfortable using a computer?" and "Are you willing to be the primary caregiver for a participant and learn how to administer tACS?" stated availability during weekdays throughout the study period to administer tACS to the Ps Exclusion Criteria: Participants (Ps) 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.) the presence of any active dermatological condition, such as eczema, on the scalp a score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person screen an inability to understand study procedures following review of the Informed Consent form Understanding 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 (see attached). Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator Administrators (As) mild cognitive impairment defined by a MoCA score ≤26 during the in-person screen insufficient understanding of study procedures following review of the Informed Consent form Understanding 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 (see attached). Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator. poor eyesight, severe arthritis in the hands, pain, deformity or other condition that interferes with successful administration of tACS

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

Citations:

PubMed Identifier

32240665

Citation

Struber D, Herrmann CS. Modulation of gamma oscillations as a possible therapeutic tool for neuropsychiatric diseases: A review and perspective. Int J Psychophysiol. 2020 Jun;152:15-25. doi: 10.1016/j.ijpsycho.2020.03.003. Epub 2020 Mar 30.

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

result

PubMed Identifier

31739167

Citation

Babiloni C, Blinowska K, Bonanni L, Cichocki A, De Haan W, Del Percio C, Dubois B, Escudero J, Fernandez A, Frisoni G, Guntekin B, Hajos M, Hampel H, Ifeachor E, Kilborn K, Kumar S, Johnsen K, Johannsson M, Jeong J, LeBeau F, Lizio R, Lopes da Silva F, Maestu F, McGeown WJ, McKeith I, Moretti DV, Nobili F, Olichney J, Onofrj M, Palop JJ, Rowan M, Stocchi F, Struzik ZM, Tanila H, Teipel S, Taylor JP, Weiergraber M, Yener G, Young-Pearse T, Drinkenburg WH, Randall F. What electrophysiology tells us about Alzheimer's disease: a window into the synchronization and connectivity of brain neurons. Neurobiol Aging. 2020 Jan;85:58-73. doi: 10.1016/j.neurobiolaging.2019.09.008. Epub 2019 Sep 19.

Results Reference

result

PubMed Identifier

30720478

Citation

Buss SS, Fried PJ, Pascual-Leone A. Therapeutic noninvasive brain stimulation in Alzheimer's disease and related dementias. Curr Opin Neurol. 2019 Apr;32(2):292-304. doi: 10.1097/WCO.0000000000000669.

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

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

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Home-based Brain Stimulation for Memory

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