DementiaACDCStimNCT05661084
Non-invasive Brain Stimulation for Cognitive and Motor Dysfunction in Dementia
A study testing Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active) in people with Dementia and Memory Loss, run by Hebrew SeniorLife at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dementia, Memory Loss, Alzheimer Disease
- What is being tested?
- Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hinda and Arthur Marcus Institute for Aging Research
Boston, Massachusetts, 02131
Alvaro Pascual-Leone, MD; PhD, 617-971-5416, homestim@hsl.harvard.edu
PhD
About this study
Official title: Multifocal Transcranial Current Stimulation for Cognitive and Motor Dysfunction in Dementia
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.
Read the detailed description
This is a randomized controlled trial to test the efficacy of a home-based brain stimulation intervention of tACS (for angular gyrus) and tDCS (for the prefrontal cortex) to improve memory, mobility, and executive function. It will include 144 older adults with mild dementia or mild cognitive impairment and their caregiver/administrator who will be trained to lead the remote, home-based brain stimulation. Participants will be randomized into one of four conditions, a) active combination of tACS + tDCS, b) combination of active tACS + sham tDCS, c) combination of sham tACS + active tDCS, and d) combination of sham tACS + sham tDCS. Participants will engage in a set of pre-intervention assessments, the brain stimulation intervention--consisting of 20, once-daily 30-min stimulation sessions administered over a 4-week period, and a set of post-intervention assessments (immediately following brain stimulation, 3 months post-brain stimulation, and 6 months post-brain stimulation). This project is expected to demonstrate that tACS and tDCS can be combined to optimize the functional impact of a home-based tES intervention for older adults with mild dementia.
- Being 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)
- 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)
- Medical subject headings
- Dementia, Memory Disorders, Alzheimer Disease, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active)Device
Also called Transcranial electrical stimulation (tES)
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)Device
Also called Transcranial electrical stimulation (sham condition)
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)Device
Also called tACS active; 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)Device
Also called tACS sham; 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.
| Study group | Role | What they receive |
|---|---|---|
| tACS(AG) + tDCS(PFC) combo active | Experimental | 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). Receives: Device: Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active) |
| tACS(AG) active + tDCS(PFC) sham | Active comparator | 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). Receives: Device: Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (sham) |
| tACS(AG) sham + tDCS(PFC) active | Active comparator | 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). Receives: Device: Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (active) |
| tACS(AG) sham + tDCS(PFC) sham | Sham comparator | 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). Receives: Device: Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Rey Auditory Verbal Learning Test (RAVLT) Total Recall
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.
Measured: baseline, immediate post-intervention, 3 month follow up , 6 month follow up
Change in Dual Task Cost to Gait
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.
Measured: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Secondary outcomes (10)
Change in Functional Activity Questionnaire
This is a 10-item scale to measure functional status via independent activities of daily living. Each item is a functional activity, and the caregiver/informant rates the participant's ability using the following scoring system:
- Dependent = 3
- Requires assistance = 2
- Has difficulty but does by self = 1
- Normal = 0
- Never did [the activity] but could do now = 0
- Never did and would have difficulty now = 1
The scores are summed (range 0-30). Cut-point of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment. This test will be used to track functional status over the course of the intervention and follow-up.
Measured: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Change in Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores
The Montreal Cognitive Assessment (MoCA) is designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains. The total possible score is 30 points; a score of 26 or above is considered normal. Severity of impairment can be determined with the following scores: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment. The maximum total score is 30 and the minimum total score is 0 points. The memory and executive subscales are each on a range of 0 to 5 points.
Measured: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Average E-field normal component (En) for left angular gyrus and prefrontal cortex
From magnetic resonance imaging, an E-field normal component value will be computer for each brain voxel. From those measurements an average En value will be computed in the anatomically-defined left AG (i.e., Brodmann areas 39/40), and separately the left PFC (i.e., Brodmann areas 39/40). This outcome of average En will provide information on the amount of current each participant receives during the intervention in the targeted areas.
Measured: immediate post-intervention
Change in Adjusted Trail Making Test performance
The Trail Making Test (TMT) is a test of visual attention and task switching, which consists of two parts (A \& B). It is scored by timing how long it takes to complete each part of the test, separately. The maximum time allowed for part A or part B is 300 seconds. Age and education adjusted norms are available to determine standard scores. The Adjusted performance is calculated by subtracting the time it takes to complete part A (in seconds) from the time it takes (in seconds) to complete part B. This is a measure of executive functioning and also has age and education adjusted norms.
Measured: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Change in Stroop test response latency
The Stroop test assess the participant's ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. The outcome of response latencies, specifically, measures the average reaction time (in milliseconds) of the participant to a) the congruent trials (colors match words) and b) the incongruent trials (colors do not match words). The average difference between congruent and incongruent response latencies will be examined.
Measured: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Change in Gait speed
The speed of the participants gait during both a) normal walking and b) walking while counting backwards. The speed is measured by the software, Mobility Lab, which is gathered via sensor. Average gait speed varies by age and education.
Measured: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Change in Stride time variability
This is measured by the software, Mobility Lab, which is gathered via sensor as the participant is walking. The average stride time varies by age and education and is the coefficient of variation of stride times during a normal walk on a straight path.
Measured: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Change in Short Physical Performance Battery total score
This is an assessment of lower extremity function, and combines results of gait speed, chair stand and balance tests. The range of scores is from 0 to 12, with higher scores indicating better lower extremity functioning.
Measured: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Change in 12-item Short Form Health Survey (SF-12)
The Short Form - 12 is a measure of health-related quality of life. There are 12 items with responses either from 1 to 3 or 1 to 5 on a Likert-type scale. Standardized scores are calculated for a physical component summary (PCS) and a mental component summary (PCS), with an average of 50 and a standard deviation of 10 and higher scores with better functioning.
Measured: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Change in Average daily step count
An average daily step count will be computed from data collected through an activity monitor over a 7-day period. The average of the 7 days will be computed for an average daily step count.
Measured: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start24 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, sham-controlled, double-blinded, parallel-arm trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Collaborators
- BrightFocus Foundation, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Alvaro Pascual-Leone, MD; PhD, Principal investigator, Hebrew SeniorLifeBrad Manor, PhD, Principal investigator, Hebrew SeniorLife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661084
- Sponsor's protocol ID
- Pro00059707
- Other IDs
- 1R01AG076708
- Acronym
- ACDCStim
- Status last verified
- Jan 2026
- First submitted
- 25 Aug 2022
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The prospective plan is to have data available in a data dementia-related data repository.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifocal Transcranial Current Stimulation for Cognitive and Motor Dysfunction in Dementia
- ClinicalTrials.gov ID
- NCT05661084
- Acronym / sponsor ID
- ACDCStim / Pro00059707
- 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)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Collaborators
- BrightFocus Foundation, National Institute on Aging (NIA)
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized controlled trial to test the efficacy of a home-based brain stimulation intervention of tACS (for angular gyrus) and tDCS (for the prefrontal cortex) to improve memory, mobility, and executive function. It will include 144 older adults with mild dementia or mild cognitive impairment and their caregiver/administrator who will be trained to lead the remote, home-based brain stimulation. Participants will be randomized into one of four conditions, a) active combination of tACS + tDCS, b) combination of active tACS + sham tDCS, c) combination of sham tACS + active tDCS, and d) combination of sham tACS + sham tDCS. Participants will engage in a set of pre-intervention assessments, the brain stimulation intervention--consisting of 20, once-daily 30-min stimulation sessions administered over a 4-week period, and a set of post-intervention assessments (immediately following brain stimulation, 3 months post-brain stimulation, and 6 months post-brain stimulation). This project is expected to demonstrate that tACS and tDCS can be combined to optimize the functional impact of a home-based tES intervention for older adults with mild dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, sham-controlled, double-blinded, parallel-arm trial
| Arm | Type | Receives |
|---|---|---|
| tACS(AG) + tDCS(PFC) combo active | Experimental | Device: Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (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). |
| tACS(AG) active + tDCS(PFC) sham | Active comparator | Device: Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (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). |
| tACS(AG) sham + tDCS(PFC) active | Active comparator | Device: Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (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). |
| tACS(AG) sham + tDCS(PFC) sham | Sham comparator | Device: Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (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). |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active)Also: Transcranial electrical stimulation (tES)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. | Device | tACS(AG) + tDCS(PFC) combo active |
| Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (sham)Also: Transcranial electrical stimulation (sham condition)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. | Device | tACS(AG) sham + tDCS(PFC) sham |
| Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (sham)Also: tACS active; tDCS shamTranscranial 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. | Device | tACS(AG) active + tDCS(PFC) sham |
| Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (active)Also: tACS sham; tDCS activeTranscranial 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. | Device | tACS(AG) sham + tDCS(PFC) active |
Primary outcome
Change in Rey Auditory Verbal Learning Test (RAVLT) Total Recall
Time frame: baseline, 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 Gait
Time frame: baseline, 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.
10 secondary outcomes
Change in Functional Activity Questionnaire
Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Change in Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores
Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Average E-field normal component (En) for left angular gyrus and prefrontal cortex
Time frame: immediate post-intervention
Change in Adjusted Trail Making Test performance
Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Change in Stroop test response latency
Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Change in Gait speed
Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Change in Stride time variability
Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Change in Short Physical Performance Battery total score
Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Change in 12-item Short Form Health Survey (SF-12)
Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Change in Average daily step count
Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Yes. The prospective plan is to have data available in a data dementia-related data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alvaro Pascual-Leone, MD; PhD principal investigator
Hebrew SeniorLife
Brad Manor, PhD principal investigator
Hebrew SeniorLife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active) in people with Dementia and Memory Loss, run by Hebrew SeniorLife at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HomeStim Study (617-971-5416, homestim@hsl.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.