An interventional study of Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active) and Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (sham) in Dementia, Memory Loss and Alzheimer Disease, sponsored by Hebrew SeniorLife. Recruiting at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by Hebrew SeniorLife · Not applicable, Interventional, and Treatment
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.
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 144 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Hebrew SeniorLife is the lead sponsor of 38 studies on the registry; 7 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Compared within Alzheimer Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dementia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants (Ps)
Caregiver/Administrators (As)
Exclusion Criteria:
Participants (Ps)
Caregiver/Administrators (As)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
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 sham intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As).
Device: Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (sham)
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).
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 sham intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As).
Device: Transcranial alternating current stimulation (tACS) (sham); 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 to the left angular gyrus and prefrontal cortex.
Also known as: Transcranial electrical stimulation (tES)
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.
Also known as: Transcranial electrical stimulation (sham condition)
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.
Also known as: 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. Sham tACS to the left angular gyrus and active tDCS to the prefrontal cortex.
Also known as: tACS sham; tDCS active
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.
Time frame: 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.
Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, immediate post-intervention, 3 month follow up, 6 month follow up
Plan to share: Yes — The prospective plan is to have data available in a data dementia-related data repository.
Supporting information: Study protocol, Statistical analysis plan
Time frame: This is a multi-year study and the data will be available at the finish, when the data is unblinded.
Access criteria: Depending on the repositories in which the data is held. However, use of the data will be restricted by permission and appropriate human subjects review of the prospective project.
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Dec 2026, 47 months after the start.
Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 47 months is above that.
Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
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