Alzheimer DementiaISTIM-ADNCT04289402
Individualized Brain Stimulation to Improve Mobility in Alzheimer's Disease
A study testing Personalized tDCS in people with Alzheimer Dementia and Presenile Alzheimer Dementia, run by Hebrew SeniorLife at 1 site in United States.
Trial summary
The objective of this study is to conduct a pilot, randomized sham-controlled trials to determine the feasibility and effects of a 10-session personalized tDCS intervention targeting the left dorsolateral prefrontal cortex on cognitive function, dual task standing and walking, and other metrics of mobility in 24 older… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Dementia, Presenile Alzheimer Dementia, Aging
- What is being tested?
- Personalized tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2020to 31 Dec 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Men and women aged 65 and older living within supportive housing facilities
- Mild Alzheimer's disease (AD) defined by the combination of 1) at least mild cognitive impairment defined as a modified TICS score of ≤ 34, 2) informant-report of Instrumental Activities of Daily Living impairment as defined as a score of ≥ 6 on the NACC Functional Activities Questionnaire, and 3) a Clinical Dementia Rating score of 1.
Who cannot join
- Inability to secure informant participation
- Unwillingness to cooperate or participate in the study protocol
- An inability to ambulate without the assistance of another person (canes or walkers allowed)
- A clinical history of stroke, Parkinson's disease or parkinsonian symptoms, multiple sclerosis, normal pressure hydrocephalus, or other neurological conditions outside of mild AD.
- Any report of severe lower-extremity arthritis or physician-diagnosis of peripheral neuropathy
- Use of antipsychotics, anti-seizure, benzodiazepines, or other neuroactive medications
Show all 9Show fewer
- Severe depression defined by a Center for Epidemiologic Studies Depression scale score greater than 16
- Any report of physician-diagnosis of schizophrenia, bipolar disorder, or other psychiatric illness
- Contraindications to MRI or tDCS, including reported seizure within the past two years, use of neuropsychological-active drugs, the risk of metal objects anywhere in the body, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemakers, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp
Trial locations and contacts
1 site in 1 country.
United States1 site
Hebrew Rehabilitation Center
Roslindale, Massachusetts, 02131
About this study
Official title: Modulating Brain Activity to Improve Cognitive-motor Function in Alzheimer's Disease
The objective of this study is to conduct a pilot, randomized sham-controlled trials to determine the feasibility and effects of a 10-session personalized tDCS intervention targeting the left dorsolateral prefrontal cortex on cognitive function, dual task standing and walking, and other metrics of mobility in 24 older adults with mild AD living in supportive housing.
Read the detailed description
Beyond the profound impact on memory, Alzheimer's disease (AD) neuropathology, even in its early stages, affects the prefrontal lobes leading to executive dysfunction and mobility disturbances. Prefrontal cortex functions, including executive control, attention, and working memory, are known to decline with the progression of AD. In older adults, better performance on executive cognitive tasks is associated with greater activation of the left dorsolateral prefrontal cortex (dlPFC). Reduced activation within the dlPFC is believed to play a role in both the executive and physical functioning declines seen in AD, significantly contributing to loss of functional independence. In mild AD, an individual's state of executive functioning is a sensitive predictor of the ability to stand and walk safely, especially when performing additional cognitive tasks (i.e., dual tasking). Therefore, the investigators contend that by facilitating the excitability of the left dlPFC, some of the early cognitive and mobility impairments of AD may be reduced, ultimately leading to more functional independence, increased physical activity, and improved quality of life.
tDCS provides a noninvasive means of facilitating the excitability of the prefrontal cortex and its connected neural networks, and thus holds promise as a therapy to improve the executive control of cognition and mobility in older adults with mild AD. tDCS modulates cortical excitability by passing low-level currents through electrodes placed upon the scalp over the dlPFC. These currents induce electrical fields within the brain that in turn polarize neuronal populations and alter their likelihood of firing. The research team demonstrated in older adults aged 65 years and older with executive dysfunction and slow gait that 10 sessions of 20-minutes of tDCS targeting the left dlPFC improved cognitive and physical functioning for at least two weeks following the intervention. Considerable evidence, including our preliminary studies, now suggest that multi-session tDCS interventions targeting the dlPFC may induce measurable and meaningful improvements in cognitive and/or mobility outcomes in relatively healthy adults and in those with mild-to-moderate executive dysfunction. Still, the size and duration of tDCS-induced benefits in older adults with executive dysfunction have not been established. Moreover, to date, tDCS delivery has not attempted to account for interpersonal differences in older adults, particularly the high inter-individual variance in skin, skull, brain, and cerebrospinal fluid and how each of these characteristics impacts the current flow. Such personalization is now possible with the current flow modeling the investigators propose.
The overall aim of the study is to conduct a pilot, randomized sham-controlled trial to determine the feasibility and effects of a 10-session personalized tDCS intervention targeting the left dlPFC on cognitive function, dual task standing and walking, and other metrics of mobility in 24 older adults with mild AD living in supportive housing. The investigators will include personalized current flow modeling approach using baseline structural MRIs to determine the tDCS electrode placement and stimulation parameters to optimize current flow to each participant's brain. The investigators do not expect tDCS to revere the structural brain changes that result from AD, but instead maximize the function of remaining, intact brain neurons and frontal networks, and thereby improve functional outcomes in people suffering from the neurodegenerative process.
The investigators hypothesize that, in older adults 65 years and older with mild AD, a personalized tDCS intervention targeting the left dlPFC, as compared to sham, will mitigate dual task costs to the control of gait and standing posture and enhance executive functioning.
- Conditions
- Alzheimer Dementia, Presenile Alzheimer Dementia, Aging
- Being tested
- Personalized tDCS, Active-Sham
- Keywords
- Aging
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized tDCSOther
The participant will receive 10, 20-minutes sessions of personalized tDCS Monday-Friday, at approximately the same time of day, over two consecutive weeks.
Active-ShamOther
The participant will receive 20, 20-minute sessions of active-sham stimulation Monday-Friday, at approximately the same time of day, over two consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Personalized tDCS | Experimental | Baseline MRIs will enable personalization of tDCS via current flow modeling for optimization to each participant with the goal of generating an average electric field of 0.25 V/m within their identified left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA and the total amount of current from all electrodes will not exceed 4 mA. Each 20-minutes session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort. Receives: Other: Personalized tDCS |
| Active-Sham | Sham comparator | The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS. Receives: Other: Active-Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment efficiency
The number of residents that need to be screened in order to enroll one participant into the trial.
Measured: 1 year
Retention
The percentage of enrolled participants who complete the trial.
Measured: 1 year
Blinding
A blinding efficacy questionnaire will be used to record participant guesses of their assigned intervention (real or placebo), as well as the confidence of these guesses on a scale from 1=Not confident to 10=Extremely confident.
Measured: Immediately after intervention
Montreal Cognitive Assessment (MoCA) total score
This common test assesses global cognitive function. Maximum score on the MoCA is 30 points (minimum = 0), with higher scores associated with better outcomes.
Measured: Change from baseline to two-week follow-up
Dual task gait speed
This metric assesses the ability to control gait while performing a secondary cognitive task.
Measured: Change from baseline to two-week follow-up
Dual task standing postural sway area
This metric assesses the ability to control standing posture while performing a secondary cognitive task.
Measured: Change from baseline to two-week follow-up
Secondary outcomes (10)
Trail making test A-B
This metric assesses cognitive executive function.
Measured: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Digit Span
This common test assesses working memory.
Measured: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Digit Symbol Substitution Test
This common test assesses sustained attention and motor speed.
Measured: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Category and Phonemic Fluency Test
This common test assesses word retrieval.
Measured: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Hopkins Verbal Learning Test
This common test assesses memory.
Measured: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Dual task stride time variability
This metric assesses the ability to control gait while performing a secondary cognitive task.
Measured: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Dual task standing postural sway speed
This metric assesses the ability to control standing posture while performing a secondary cognitive task.
Measured: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Timed Up-and-Go
This metric assesses mobility.
Measured: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Five-day accelerometry-based physical activity
This metric assesses the quantity and quality of habitual physical activity.
Measured: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Centers for Epidemiologic Studies Depression Scale
This metric assesses mood.
Measured: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start31 Jan 2020
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer 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
- The investigators will conduct a single site, sham-controlled, double-blinded, randomized trial of tDCS. Participants will complete baseline cognitive and physical functioning assessments, as well as a structural MRI of the brain. They will then be assigned to a two-week, 10-session intervention of either personalized tDCS sham (i.e., control) stimulation, via permuted block randomization stratified by sex to ensure that equal number of men and women are randomized to each intervention arm.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brad Manor, Hebrew SeniorLife
- Investigators
- Brad Manor, PhD, Principal investigator, Hebrew SeniorLife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289402
- Sponsor's protocol ID
- 3P30AG031679-09S1
- Acronym
- ISTIM-AD
- Status last verified
- Apr 2026
- First submitted
- 13 Feb 2020
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The HSL Institute for Aging Research will promote the development of new research and new investigators by making the data available to outside investigators. The database will include longitudinal demographic, clinical, functional, physiologic, and brain imaging data, from all participants. All data will be stripped of primary identifiers and entered into a master database. All data collection procedures, variable definitions and codes, field locations, and frequencies will be documented in a separate file.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Brain Activity to Improve Cognitive-motor Function in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04289402
- Acronym / sponsor ID
- ISTIM-AD / 3P30AG031679-09S1
- Conditions
- Alzheimer Dementia, Presenile Alzheimer Dementia, Aging
- Keywords
- Aging
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Feb 2020 (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.
The objective of this study is to conduct a pilot, randomized sham-controlled trials to determine the feasibility and effects of a 10-session personalized tDCS intervention targeting the left dorsolateral prefrontal cortex on cognitive function, dual task standing and walking, and other metrics of mobility in 24 older adults with mild AD living in supportive housing.
Detailed description
Beyond the profound impact on memory, Alzheimer's disease (AD) neuropathology, even in its early stages, affects the prefrontal lobes leading to executive dysfunction and mobility disturbances. Prefrontal cortex functions, including executive control, attention, and working memory, are known to decline with the progression of AD. In older adults, better performance on executive cognitive tasks is associated with greater activation of the left dorsolateral prefrontal cortex (dlPFC). Reduced activation within the dlPFC is believed to play a role in both the executive and physical functioning declines seen in AD, significantly contributing to loss of functional independence. In mild AD, an individual's state of executive functioning is a sensitive predictor of the ability to stand and walk safely, especially when performing additional cognitive tasks (i.e., dual tasking). Therefore, the investigators contend that by facilitating the excitability of the left dlPFC, some of the early cognitive and mobility impairments of AD may be reduced, ultimately leading to more functional independence, increased physical activity, and improved quality of life.
tDCS provides a noninvasive means of facilitating the excitability of the prefrontal cortex and its connected neural networks, and thus holds promise as a therapy to improve the executive control of cognition and mobility in older adults with mild AD. tDCS modulates cortical excitability by passing low-level currents through electrodes placed upon the scalp over the dlPFC. These currents induce electrical fields within the brain that in turn polarize neuronal populations and alter their likelihood of firing. The research team demonstrated in older adults aged 65 years and older with executive dysfunction and slow gait that 10 sessions of 20-minutes of tDCS targeting the left dlPFC improved cognitive and physical functioning for at least two weeks following the intervention. Considerable evidence, including our preliminary studies, now suggest that multi-session tDCS interventions targeting the dlPFC may induce measurable and meaningful improvements in cognitive and/or mobility outcomes in relatively healthy adults and in those with mild-to-moderate executive dysfunction. Still, the size and duration of tDCS-induced benefits in older adults with executive dysfunction have not been established. Moreover, to date, tDCS delivery has not attempted to account for interpersonal differences in older adults, particularly the high inter-individual variance in skin, skull, brain, and cerebrospinal fluid and how each of these characteristics impacts the current flow. Such personalization is now possible with the current flow modeling the investigators propose.
The overall aim of the study is to conduct a pilot, randomized sham-controlled trial to determine the feasibility and effects of a 10-session personalized tDCS intervention targeting the left dlPFC on cognitive function, dual task standing and walking, and other metrics of mobility in 24 older adults with mild AD living in supportive housing. The investigators will include personalized current flow modeling approach using baseline structural MRIs to determine the tDCS electrode placement and stimulation parameters to optimize current flow to each participant's brain. The investigators do not expect tDCS to revere the structural brain changes that result from AD, but instead maximize the function of remaining, intact brain neurons and frontal networks, and thereby improve functional outcomes in people suffering from the neurodegenerative process.
The investigators hypothesize that, in older adults 65 years and older with mild AD, a personalized tDCS intervention targeting the left dlPFC, as compared to sham, will mitigate dual task costs to the control of gait and standing posture and enhance executive functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators will conduct a single site, sham-controlled, double-blinded, randomized trial of tDCS. Participants will complete baseline cognitive and physical functioning assessments, as well as a structural MRI of the brain. They will then be assigned to a two-week, 10-session intervention of either personalized tDCS sham (i.e., control) stimulation, via permuted block randomization stratified by sex to ensure that equal number of men and women are randomized to each intervention arm.
| Arm | Type | Receives |
|---|---|---|
| Personalized tDCS | Experimental | Other: Personalized tDCSBaseline MRIs will enable personalization of tDCS via current flow modeling for optimization to each participant with the goal of generating an average electric field of 0.25 V/m within their identified left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA and the total amount of current from all electrodes will not exceed 4 mA. Each 20-minutes session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort. |
| Active-Sham | Sham comparator | Other: Active-ShamThe investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Men and women aged 65 and older living within supportive housing facilities
- Mild Alzheimer's disease (AD) defined by the combination of 1) at least mild cognitive impairment defined as a modified TICS score of ≤ 34, 2) informant-report of Instrumental Activities of Daily Living impairment as defined as a score of ≥ 6 on the NACC Functional Activities Questionnaire, and 3) a Clinical Dementia Rating score of 1.
Key exclusion criteria (9 listed)
- Inability to secure informant participation
- Unwillingness to cooperate or participate in the study protocol
- An inability to ambulate without the assistance of another person (canes or walkers allowed)
- A clinical history of stroke, Parkinson's disease or parkinsonian symptoms, multiple sclerosis, normal pressure hydrocephalus, or other neurological conditions outside of mild AD.
- Any report of severe lower-extremity arthritis or physician-diagnosis of peripheral neuropathy
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 |
|---|---|---|
| Personalized tDCSThe participant will receive 10, 20-minutes sessions of personalized tDCS Monday-Friday, at approximately the same time of day, over two consecutive weeks. | Other | Personalized tDCS |
| Active-ShamThe participant will receive 20, 20-minute sessions of active-sham stimulation Monday-Friday, at approximately the same time of day, over two consecutive weeks. | Other | Active-Sham |
Primary outcome
Recruitment efficiency
Time frame: 1 year
The number of residents that need to be screened in order to enroll one participant into the trial.
Retention
Time frame: 1 year
The percentage of enrolled participants who complete the trial.
Blinding
Time frame: Immediately after intervention
A blinding efficacy questionnaire will be used to record participant guesses of their assigned intervention (real or placebo), as well as the confidence of these guesses on a scale from 1=Not confident to 10=Extremely confident.
Montreal Cognitive Assessment (MoCA) total score
Time frame: Change from baseline to two-week follow-up
This common test assesses global cognitive function. Maximum score on the MoCA is 30 points (minimum = 0), with higher scores associated with better outcomes.
Dual task gait speed
Time frame: Change from baseline to two-week follow-up
This metric assesses the ability to control gait while performing a secondary cognitive task.
Dual task standing postural sway area
Time frame: Change from baseline to two-week follow-up
This metric assesses the ability to control standing posture while performing a secondary cognitive task.
10 secondary outcomes
Trail making test A-B
Time frame: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Digit Span
Time frame: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Digit Symbol Substitution Test
Time frame: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Category and Phonemic Fluency Test
Time frame: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Hopkins Verbal Learning Test
Time frame: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Dual task stride time variability
Time frame: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Dual task standing postural sway speed
Time frame: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Timed Up-and-Go
Time frame: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Five-day accelerometry-based physical activity
Time frame: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
Centers for Epidemiologic Studies Depression Scale
Time frame: Baseline, within 3 days after completion of the intervention, two weeks after completing the intervention
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 27 Apr 2026.
- Individual participant dataSharing planned: Yes. The HSL Institute for Aging Research will promote the development of new research and new investigators by making the data available to outside investigators. The database will include longitudinal demographic, clinical, functional, physiologic, and brain imaging data, from all participants. All data will be stripped of primary identifiers and entered into a master database. All data collection procedures, variable definitions and codes, field locations, and frequencies will be documented in a separate file.
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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. This study is not recruiting at the moment.
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 Personalized tDCS in people with Alzheimer Dementia and Presenile Alzheimer Dementia, 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 2 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment efficiency (time frame: 1 year). The study lists 6 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 27 Apr 2026.