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

Launched by HEBREW SENIORLIFE · Dec 13, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help older adults with mild cognitive impairment or mild dementia, including conditions like Alzheimer’s disease. The study will test a non-invasive brain stimulation method, led by caregivers, to see if it can improve memory, mobility, and thinking skills. The goal is to find out if this brain stimulation can make daily activities easier and improve overall quality of life for participants.

To join the study, participants must be able to understand and sign a consent form, communicate in English, and have a caregiver who can help administer the treatment. The caregiver should be at least 21 years old, comfortable using a computer, and available during weekdays. Some people may not be eligible, such as those with certain serious mental health conditions or specific medical devices. If you or someone you know is interested in participating, it’s a good idea to discuss it with a healthcare provider to see if it’s a suitable option. Participants will receive guidance throughout the study and will have the ability to withdraw at any time if they choose.

Gender

ALL

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
• • Caregiver/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 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
• 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 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
• • Caregiver/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. 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

Trial Officials