NCT05661084 Non-invasive Brain Stimulation for Cognitive and Motor Dysfunction in Dementia
| NCT ID | NCT05661084 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hebrew SeniorLife |
| Condition | Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2023-01-24 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2023-01-24 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 Caregiver/Administrators (As) * at least 18 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
Contact & Investigator
Alvaro Pascual-Leone, MD; PhD
PRINCIPAL INVESTIGATOR
Hebrew SeniorLife
Frequently Asked Questions
Who can join the NCT05661084 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05661084 currently recruiting?
Yes, NCT05661084 is actively recruiting participants. Contact the research team at homestim@hsl.harvard.edu for enrollment information.
Where is the NCT05661084 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05661084 clinical trial?
NCT05661084 is sponsored by Hebrew SeniorLife. The principal investigator is Alvaro Pascual-Leone, MD; PhD at Hebrew SeniorLife. The trial plans to enroll 144 participants.