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Non-invasive Brain Stimulation for Dementia

This study is testing if a home-based brain stimulation treatment, given by a caregiver, can help improve memory, movement, and thinking skills in older adults with mild cognitive impairment or mild dementia. The treatment uses two types of electrical stimulation: transcranial alternating current stimulation (tACS) and transcranial direct current stimulation (tDCS). You would be between 55 years old and older, able to understand and sign consent forms, and speak English. The study aims to see if these treatments can improve your memory (measured by a verbal learning test) and how well you walk while doing another task. The current status of this study is unclear.

Study design
This is a randomized controlled trial involving 144 participants. Participants will be assigned to one of four groups: active tACS and tDCS, active tACS and sham (inactive) tDCS, sham tACS and active tDCS, or sham tACS and sham tDCS.
What's involved
You will have assessments before the treatment, then receive 20 daily 30-minute stimulation sessions over four weeks at home, administered by your caregiver. You will also have assessments immediately after treatment, and again at 3 and 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after the brain stimulation treatment ends.

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NCT05661084

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

Recruiting
NAAges 55+InterventionalTreatment
Hebrew SeniorLife
~144 participants
Updated 2026-01-12 on ClinicalTrials.gov
What's tested: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)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Rey Auditory Verbal Learning Test (RAVLT) Total Recall
Measured over baseline, immediate post-intervention, 3 month follow up , 6 month follow up
+1 more outcome measured

Conditions

Dementia
Memory Loss
Alzheimer Disease
Executive Dysfunction
Mobility Limitation

Explore related trials

Alzheimer's DiseaseDementiaMild cognitive disorder

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

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

Who to contact

HomeStim Study
[email protected]
617-971-5416
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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

What this trial measures

  • Change in Rey Auditory Verbal Learning Test (RAVLT) Total Recallbaseline, immediate post-intervention, 3 month follow up , 6 month follow up

    This test is designed to evaluate verbal memory in those 16 years of age and older. It can be used to evaluate the nature and severity of memory dysfunction and to track changes in memory function over time. Total recall is measured by the total number of words out of 15 the participant is able to recall. Scores range from 0 to 15.

  • Change in Dual Task Cost to Gaitbaseline, immediate post-intervention, 3 month follow up, 6 month follow up

    This measure is captured by Mobility Lab™ (APDM Inc) software while the participant is walking with sensors at a) normal speed (speed for single task) and b) walking while counting backwards by 3's or 1's (speed dual task). The formula for cost of the dual task to gait is: (speedsingletask-speeddualtask)/speedsingletask)\*100). Range for dual task cost is as follows: High Risk for falls \> 0.2, Moderate Risk for falls \<= 0.2, Low Risk \< 0.1.