Non-invasive brain stimulation to improve cognitive and motor function in dementia patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project examines the effectiveness of a caregiver-led, home-based brain stimulation intervention using transcranial alternating current stimulation (tACS) and transcranial direct current stimulation (tDCS) to enhance memory, mobility, and executive function in older adults with mild cognitive impairment or mild dementia. The study will involve 144 participants who will be randomized into four groups receiving different combinations of active and sham stimulation. Each participant will undergo 20 sessions of stimulation over four weeks, with assessments conducted before, immediately after, and at three and six months post-intervention. The goal is to determine if combining tACS and tDCS can optimize functional outcomes for these patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Hinda and Arthur Marcus Institute for Aging Research
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Alvaro Pascual-Leone, MD; PhD — Hebrew SeniorLife
• Study coordinator: HomeStim Study
• Email: homestim@hsl.harvard.edu
• Phone: 617-971-5416

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.