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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)
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 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

First Posted
February 26, 2021
Last Updated
September 20, 2023
Sponsor
Hebrew SeniorLife
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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
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

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
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.
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
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
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
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
No
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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