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Alzheimer Disease and Related DementiasTDCS4MCRNCT06821568

Home-Based Brain Stimulation for Motoric Cognitive Risk Syndrome

A study testing Personalized Transcranial Direct Current Stimulation (tDCS) in people with Alzheimer Disease and Related Dementias and Cognition, run by Hebrew SeniorLife at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The objective of this study is to determine the effects of a 6-month, home-based personalized transcranial direct current stimulation (tDCS) intervention targeting the left dorsolateral prefrontal cortex on cognitive function, dual task standing and walking, and other metrics of mobility in older adults with motoric… Read more about this study

Who is it for?
Ages 65 to 90 years
What is being tested?
Personalized Transcranial Direct Current Stimulation (tDCS)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
2 sitesin 2 countries
Study dates
2 Sep 2025to Jun 2029
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Men and women
  • Age 65-90 years
  • Subjective cognitive complaints as defined by a 'Yes' response to "Do you feel that you have more problems with memory than most?" or a 'No' response to "is your mind as clear as it used to be?"
  • Montreal Cognitive Assessment (MoCA) score ≥21
  • Slow gait speed as measured by averaging two 4-Meter walks and defined as a usual walking speed one standard deviation below age and sex-adjusted means.
  • Absence of significant disability as defined by the ability to walk over the instrumented gait mat unassisted (e.g., able to walk without any walking aids for at least 2 minutes non-stop) and preserved activities of daily living as defined by a score of less than 9 on the Functional Activities Questionnaire.
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  • Identification of an eligible informant
  • Identification of a willing and able tDCS-administrator; i.e., a study partner to lead the administration of home-based transcranial direct current stimulation (tDCS)
  • Access to reliable WiFi in the participant's home

Who cannot join

  • Formal education less than the 8th grade
  • Previous physician diagnosis of dementia
  • Any current diagnosis of a major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depressive disorder)
  • Evidence of moderate-to-severe depressive symptoms defined by a score of ≥9 on the 15-item Geriatric Depression Scale
  • History of head trauma resulting in prolonged loss of consciousness
  • History of fainting spells of unknown or undetermined etiology that might constitute seizures
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  • History of seizures, diagnosis of epilepsy, or immediate (first-degree relative) family history of epilepsy except for a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
  • Hospitalization within the past three months due to acute illness, or as the result of a musculoskeletal injury significantly affecting gait or balance
  • Any unstable medical condition or chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.) or study complication
  • Substance use disorders within the past six months
  • A hairstyle or headdress that prevents electrode contact with the scalp or would interfere with the stimulation (for example thick braids, hair weave, afro, wig)
  • Chronic vertigo
  • Myocardial infarction within the past 6 months
  • Active cancer for which chemo-/radiation therapy is being received
  • Legal blindness
  • Visual hallucinations (history or self-report)
  • Pacemaker
  • Contraindications to MRI or tDCS, including unprovoked seizure within the past two years, risk of ferromagnetic objects anywhere in the body, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), the presence of any active dermatological condition, such as eczema, on the scalp, etc. as outlined by current recommendations for noninvasive brain stimulation endorsed by the International Federation for Clinical Neurophysiology.
  • History of REM sleep behavior disorder (RBD), often an early sign of Parkinson's disease
  • Medications and medical history will be reviewed by the responsible covering physician and a decision about inclusion will be made based on the participant's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other CNS active drugs.

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

2 sites in 2 countries

United States1 site, 1 recruiting
  • Hebrew Rehabilitation Center

    Roslindale, Massachusetts, 02131

    Katie Baldyga, BA, 617-971-5380, Kathrynbaldyga@hsl.harvard.edu

    Juhi Salecha, MS, 617-971-5398, JuhiSalecha@hsl.harvard.edu

    Recruiting

Other trials in United States

Israel1 site, 1 recruiting
  • Tel Aviv Sourasky Medical Center

    Tel Aviv

    Marina Brozgol, marinab@tlvmc.gov.il

    Jeff Hausdorff, PhD

    Recruiting

Other trials in Israel

About this study

Official title: Long-term Home-based Transcranial Electrical Stimulation for Cognitive and Motor Function in Older Adults With an Increased Risk of Dementia: a Randomized Controlled Trial

The objective of this study is to determine the effects of a 6-month, home-based personalized transcranial direct current stimulation (tDCS) intervention targeting the left dorsolateral prefrontal cortex on cognitive function, dual task standing and walking, and other metrics of mobility in older adults with motoric cognitive risk syndrome (MCR).

Read the detailed description

In older adults, motoric cognitive risk (MCR) is a pre-dementia transition state between "normal" aging and dementia. MCR is associated with impaired function within several brain networks that causes numerous symptoms including loss of memory, the ability to complete complex mental tasks, and the capacity to control one's walking and thus avoid falling and fall-related injuries. This study seeks to assess the short-term and long-term use of an investigational device called a transcranial direct current stimulation (tDCS).

tDCS is a noninvasive technology that enables selective modulation of brain network function, to provide multi-symptom relief to older adults with MCR. By using state-of-the-art technology to 1) utilize a personalized tDCS intervention via an established optimization approach using individual brain MRIs, and 2) complete stimulation in a home-based setting, this study is expected to result in the development of tDCS interventions that have maximal impact on daily life function within this population.

In this study, investigators will conduct a 9-month sham-controlled, double-blinded, multi-site trial in 128 older adults aged 65-90 years old with MCR. All enrolled participants will complete an open-label 2-week, 10-session tDCS intervention. During the open-label phase of the study, all participants will receive active tDCS. Then, participants will be randomly assigned into either the tDCS arm that receives five weekly tDCS sessions for 6 months, or a combination arm of five weekly tDCS sessions for 3 months before or after five weekly sessions of sham for 3 months. Sham treatment is similar to the study tDCS treatment, but omits the key therapeutic element of the treatment being studied. Participants in the combination arm will not know whether they are receiving tDCS or sham during the first or second 3-month period. Enrolled participants will complete assessments relating to cognition, mood, balance, and memory at baseline, after the 2-week open-label phase, after 3 and 6 months of tDCS, and again 3 months later. Once a week, participants will also complete a gait (walking) assessment at home. MRI scans will be performed at baseline, after completing 3 months of tDCS, and after completing 6 months of tDCS.

Being tested
Personalized Transcranial Direct Current Stimulation (tDCS), Active-Sham
Keywords
Anatomy, Anxiety, Atrophic, Behavioral, Brain, Brain Region, Cephalic, Cognitive, Communities, Dementia, Development, Dose, Double-Blind Method, Electric Stimulation, Enrollment, Evaluation, Exhibits, Exposure to, Frequencies, Future
Medical subject headings
Alzheimer Disease, Anxiety Disorders, Atrophy, Behavior, Dementia, Cognition Disorders, Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized Transcranial Direct Current Stimulation (tDCS)Other

    Home-based transcranial direct current stimulation (tDCS) tailored to target the left dlPFC.

  • Active-ShamOther

    Stimulation administered in very low-level currents (0.5 mA total) designed to not significantly influence cortical tissue, but still mimic the cutaneous sensations induced by tDCS.

Study groups in NCT06821568
Study groupRoleWhat they receive
Personalized Transcranial Direct Current Stimulation (tDCS)ExperimentalAfter an initial open-label 2-week home-based transcranial direct current stimulation (tDCS) intervention, participants will receive 5 weekly home-based tDCS sessions for 6 months. 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-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Receives: Other: Personalized Transcranial Direct Current Stimulation (tDCS)
Combination Arm; Sham Plus Personalized Transcranial Direct Current Stimulation (tDCS)Active comparatorAfter an initial open-label 2-week home-based transcranial direct current stimulation (tDCS) intervention, participants will receive a combination arm of five weekly tDCS sessions for 3 months before or after five weekly sessions of sham for 3 months. 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. Participants in the combination arm will not know whether they are receiving tDCS or sham during the first or second 3-month period.
Receives: Other: Personalized Transcranial Direct Current Stimulation (tDCS); Other: Active-Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dual task cost to gait speed

    This metric assesses the degree to which performing a secondary cognitive task diminishes the control of gait.

    Measured: Pre-randomization baseline; within three days of completing the initial open-label tDCS intervention; Month 3, Month 6; Month 9.

Secondary outcomes (8)
  1. Executive function composite score

    This metric is derived from the CANTAB computerized test battery and reflects age-, sex-, and education-based z-scores on numerous cognitive functions associated with executive function.

    Measured: Baseline, within three days of completing initial open-label tDCS intervention, Month 3, Month 6, & Month 9.

  2. Dual task gait speed

    This metric assesses the ability to walk and perform a cognitive task at the same time and predicts cognitive decline and the development of dementia.

    Measured: Baseline, within three days of completing initial open-label tDCS intervention, Month 3, Month 6, & Month 9.

  3. Preferred gait speed

    This metric assesses the preferred gait speed over the course of 4 meters.

    Measured: Baseline, within three days of completing initial open-label tDCS intervention, Month 3, Month 6, & Month 9.

  4. The change in left prefrontal deoxygenated hemoglobin between standing and dual task walking

    This metric is measured using functional near-infrared spectroscopy (fNIRS) and reflects one aspect of brain activation induced by performing the task of dual task walking and preferred speed.

    Measured: Baseline, within three days of completing initial open-label tDCS intervention, Month 3, Month 6, & Month 9.

  5. The change in left prefrontal deoxygenated hemoglobin between standing and usual walking

    This metric is measured using functional near-infrared spectroscopy (fNIRS) and reflects one aspect of brain activation induced by performing the task of usual walking and preferred speed.

    Measured: Baseline, within three days of completing initial open-label tDCS intervention, Month 3, Month 6, & Month 9.

  6. Left dorsolateral prefrontal cortex (dlPFC) gray matter volume

    This metric quantifies the volume of gray matter within the left dorsolateral prefrontal cortex (the brain target-of-interest for the tDCS intervention).

    Measured: Baseline, Month 3, & Month 6

  7. Left dorsolateral prefrontal cortex (dlPFC) functional connectivity

    This metric quantifies the strength of functional connectivity between the left dorsolateral prefrontal cortex (the brain target-of-interest for the tDCS intervention) and the rest of the brain.

    Measured: Baseline, Month 3, & Month 6

  8. 7-day accelerometry-based physical activity

    This metric assesses the quantity and quality of habitual, real-world physical activity.

    Measured: Baseline, within three days of completing initial open-label tDCS intervention, Month 3, Month 6, & Month 9.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2025
  2. Study start2 Sep 2025
  3. Primary completionMar 2029 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

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
Crossover
Model description
The investigators will conduct a multi-site, sham-controlled, double-blinded, randomized trial of home-based tDCS with stimulation parameters tailored to target the anatomically defined left dlPFC of each participant. Participants will complete baseline cognitive and physical functioning assessments, as well as a structural MRI of the brain. After an initial open-label 2-week tDCS intervention, participants will be randomized into a tDCS arm (5 weekly tDCS sessions for 6 months), or a combination arm of 5 weekly tDCS sessions for 3 months before or after 5 weekly sessions of sham for 3 months via permuted block randomization stratified by sex to ensure that equal number of men and women are randomized to each intervention arm.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06821568
Sponsor's protocol ID
00072642
Other IDs
1R01AG081349-01A1
Acronym
TDCS4MCR
Status last verified
Jul 2026
First submitted
5 Feb 2025
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified demographic, cognitive, motor, clinical, gait kinematics, free-living accelerometry, functional near infrared spectroscopy (fNIRS), MRI, and trial compliance and safety data

Questions about this trial

What is this clinical trial studying?

A study testing Personalized Transcranial Direct Current Stimulation (tDCS) in people with Alzheimer Disease and Related Dementias and Cognition, run by Hebrew SeniorLife at 2 sites in 2 countries.

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 9 inclusion and 20 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 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Israel. 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. 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 Katie Baldyga, BA (617-971-5380, Kathrynbaldyga@hsl.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dual task cost to gait speed (time frame: Pre-randomization baseline; within three days of completing the initial open-label tDCS intervention; Month 3, Month 6; Month 9.). 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 16 Jul 2026.

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