RECRUITING

Non-invasive Brain Stimulation for Cognitive and Motor Dysfunction in Dementia

Conditions

Dementia Memory Loss Alzheimer Disease Executive Dysfunction Mobility Limitation Alzheimer's Disease Memory Brain Stimulation transcranial alternating current stimulation (tACS)transcranial direct current stimulation (tDCS)Executive function instrumental activities of daily living (IADL)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This project aims to examine the efficacy of remote, caregiver-led tES/brain stimulation intervention targeted to improve memory, mobility, and executive functioning among older adults with mild cognitive impairment or mild dementia.

Official Title

Multifocal Transcranial Current Stimulation for Cognitive and Motor Dysfunction in Dementia

Quick Facts

Study Start:2023-01-24

Study Completion:2027-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05661084

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * 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 tES 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 tES?" * stated availability during weekdays throughout the study period to administer tES to the Ps	* major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis * blindness or other disabilities that prevent task performance * contraindications to tES, 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, 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. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator * 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. 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 tES

Inclusion Criteria

Exclusion Criteria

* 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
* 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 tES 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 tES?"
* stated availability during weekdays throughout the study period to administer tES to the Ps

* major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
* blindness or other disabilities that prevent task performance
* contraindications to tES, 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, 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. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator
* 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. 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 tES

Contacts and Locations

Study Contact

HomeStim Study

CONTACT

617-971-5416

homestim@hsl.harvard.edu

Principal Investigator

Alvaro Pascual-Leone, MD; PhD

PRINCIPAL_INVESTIGATOR

Hebrew SeniorLife

Brad Manor, PhD

PRINCIPAL_INVESTIGATOR

Hebrew SeniorLife

Study Locations (Sites)

Hinda and Arthur Marcus Institute for Aging Research

Boston, Massachusetts, 02131

United States

Collaborators and Investigators

Sponsor: Hebrew SeniorLife

Alvaro Pascual-Leone, MD; PhD, PRINCIPAL_INVESTIGATOR, Hebrew SeniorLife
Brad Manor, PhD, PRINCIPAL_INVESTIGATOR, Hebrew SeniorLife

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-24

Study Completion Date2027-08-31

Study Record Updates

Study Start Date2023-01-24

Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

Alzheimer's Disease
Dementia
Memory
Brain Stimulation
transcranial alternating current stimulation (tACS)
transcranial direct current stimulation (tDCS)
Executive function
instrumental activities of daily living (IADL)

Additional Relevant MeSH Terms

Dementia
Memory Loss
Alzheimer Disease
Executive Dysfunction
Mobility Limitation