Recruiting

tDCS

Sponsor:

Hebrew SeniorLife

Code:

NCT06821568

Conditions

Alzheimer Disease and Related Dementias

Cognition

Mobility Disability

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

Personalized Transcranial Direct Current Stimulation (tDCS)

Active-Sham

Study Details

Brief 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 cognitive risk syndrome (MCR).

Conditions

Alzheimer Disease and Related Dementias

Cognition

Mobility Disability

Study ID

NCT06821568

Start date

Sep 2, 2025

Status verified date

Jul, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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
  • 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.

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Personalized Transcranial Direct Current Stimulation (tDCS)

After 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.

active comparator: Combination Arm; Sham Plus Personalized Transcranial Direct Current Stimulation (tDCS)

After 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.

Interventions

Personalized Transcranial Direct Current Stimulation (tDCS)

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

Active-Sham

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.

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. ]

Central Contacts and Locations

Central contacts

Katie Baldyga, BA

617-971-5380Kathrynbaldyga@hsl.harvard.edu

Juhi Salecha, MS

617-971-5398JuhiSalecha@hsl.harvard.edu

Locations

Hebrew Rehabilitation Center

Recruiting

Roslindale, Massachusetts, United States, 02131

Contacts

Katie Baldyga, BA

617-971-5380Kathrynbaldyga@hsl.harvard.edu

Juhi Salecha, MS

617-971-5398JuhiSalecha@hsl.harvard.edu

Principal Investigator:

Brad Manor, PhD

More Information

Sponsor

Hebrew SeniorLife

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

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
  • Gait
  • Gait Speed
  • Genetic Crossing Over
  • Home
  • Impaired Cognition
  • Individual
  • Intervention
  • Intervention Studies
  • Magnetic Resonance Imaging
  • Measurable
  • Measures
  • Mood
  • Motor
  • Multi-Institutional Clinical Trial
  • Neuronal Plasticity
  • Outcome
  • Participant
  • Performance
  • Phase
  • Pilot Projects
  • Prefrontal Cortex
  • Randomized
  • Randomized Controlled Clinical Trials
  • Research
  • Resolution
  • Rest
  • Risk
  • Series
  • Site
  • Structure
  • Testing
  • Therapeutic
  • Time
  • Syndrome
  • Walking
  • Work
  • Arm
  • cerebral atrophy
  • Clinically relevant
  • cognitive task
  • Cost
  • Dementia Risk
  • Design
  • Executive Function
  • functional improvement
  • functional near infrared spectroscopy
  • Gray Matter
  • high risk
  • home test
  • improved
  • insight
  • late life
  • mental function
  • neural network
  • neuroimaging
  • noninvasive brain stimulation
  • normal aging
  • older adult
  • older men
  • older women
  • open label
  • primary endpoint
  • response
  • secondary outcome
  • smartphone application
  • transcranial direct current stimulation
  • trial design
  • walking speed
  • Alzheimer's Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hebrew SeniorLife on 2026-07-16.