Clinical trial NCT04783350: Home-based Brain Stimulation for Memory
Official title: Home-based Transcranial Alternating Current Stimulation (tACS) for Older Adults at Risk of Memory Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Memory Loss
Keywords: alzheimer disease
memory and cognition
autobiographical memory
transcranial alternating current stimulation (tACS)
guided high-density electroencephalography (hdEEG)
Lead sponsor: Hebrew SeniorLife
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Clinical Evaluation and Cognitive Assessment
timeFrame: 48 weeks
measure: Electroencephalography (EEG) measures
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Hinda and Arthur Marcus Institute for Aging Research
state: Massachusetts
Study officials:
affiliation: Hinda and Arthur Marcus Institute for Aging Research
name: Alvaro Pascual-Leone, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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