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OpenTrials
Completed

NCT Number: NCT04783350

Home-based Brain Stimulation for Memory

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

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hinda and Arthur Marcus Institute for Aging Research

Boston, Massachusetts, 02131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transcranial alternating current stimulation (tACS)

Device

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

Other names: non-invasive brain stimulation

Primary outcomes

  1. Clinical Evaluation and Cognitive Assessment

    Time frame: 48 weeks

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

  2. Electroencephalography (EEG) measures

    Time frame: 48 weeks

    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

Sponsors and collaborators

Lead sponsor

Hebrew SeniorLife

Other

Registry information

Official study title

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

Acronym: MemStim-home

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 5, 2021
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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