Recruiting

Non-invasive Brain Stimulation

Sponsor:

Hebrew SeniorLife

Code:

NCT05661084

Conditions

Dementia

Memory Loss

Alzheimer Disease

Executive Dysfunction

Mobility Limitation

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active)

Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (sham)

Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (sham)

Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (active)

Study Details

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.

Conditions

Dementia

Memory Loss

Alzheimer Disease

Executive Dysfunction

Mobility Limitation

Study ID

NCT05661084

Start date

Jan 24, 2023

Status verified date

Jan, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: tACS(AG) + tDCS(PFC) combo active

Participants (Ps) will undergo 20min of daily home-based tACS active + tDCS active intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As).

active comparator: tACS(AG) active + tDCS(PFC) sham

Participants (Ps) will undergo 20min of daily home-based tACS active + tDCS sham intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As).

active comparator: tACS(AG) sham + tDCS(PFC) active

Participants (Ps) will undergo 20min of daily home-based tACS sham + tDCS active intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As).

sham comparator: tACS(AG) sham + tDCS(PFC) sham

Participants (Ps) will undergo 20min of daily home-based tACS sham + tDCS sham intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As).

Interventions

Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active)

Transcranial electrical stimulation (tES), via alternating and direct current, will be administered to the participant in their home by their caregiver administrator to the left angular gyrus and prefrontal cortex.

Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (sham)

A sham transcranial electrical stimulation (tES) will be administered to the participant in their home by their caregiver administrator to the left angular gyrus and prefrontal cortex. It will physically mimic active stimulation.

Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (sham)

Transcranial electrical stimulation (tES), via alternating and direct current, will be administered to the participant in their home by their caregiver administrator. Active tACS to the left angular gyrus and sham tDCS to the prefrontal cortex.

Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (active)

Transcranial electrical stimulation (tES), via alternating and direct current, will be administered to the participant in their home by their caregiver administrator. Sham tACS to the left angular gyrus and active tDCS to the prefrontal cortex.

Primary outcome measure

  • Change in Rey Auditory Verbal Learning Test (RAVLT) Total Recall [ Time Frame: baseline, immediate post-intervention, 3 month follow up , 6 month follow up ]
  • Change in Dual Task Cost to Gait [ Time Frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up ]

Central Contacts and Locations

Central contacts

HomeStim Study

617-971-5416homestim@hsl.harvard.edu

Locations

Hinda and Arthur Marcus Institute for Aging Research

Recruiting

Boston, Massachusetts, United States, 02131

Contacts

Alvaro Pascual-Leone, MD; PhD

617-971-5416homestim@hsl.harvard.edu

Principal Investigator:

Brad Manor, PhD

More Information

Sponsor

Hebrew SeniorLife

Last update posted

Jan 12, 2026

Last verified

Jan, 2026

Keywords

  • 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)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hebrew SeniorLife on 2026-01-12.