An interventional study of Personalized Transcranial Direct Current Stimulation (tDCS) and Active-Sham in Alzheimer Disease and Related Dementias, Cognition and Mobility Disability, sponsored by Hebrew SeniorLife. Recruiting at 2 sites in 2 countries. Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Hebrew SeniorLife · Not applicable, Interventional, and Treatment
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).
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 128 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.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
Other: 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.
Other: Personalized Transcranial Direct Current Stimulation (tDCS) · Other: Active-Sham
Home-based transcranial direct current stimulation (tDCS) tailored to target the left dlPFC.
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.
Dual task cost to gait speed
This metric assesses the degree to which performing a secondary cognitive task diminishes the control of gait.
Time frame: Pre-randomization baseline; within three days of completing the initial open-label tDCS intervention; Month 3, Month 6; Month 9.
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.
Time frame: Baseline, within three days of completing initial open-label tDCS intervention, Month 3, Month 6, & Month 9.
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.
Time frame: Baseline, within three days of completing initial open-label tDCS intervention, Month 3, Month 6, & Month 9.
Preferred gait speed
This metric assesses the preferred gait speed over the course of 4 meters.
Time frame: Baseline, within three days of completing initial open-label tDCS intervention, Month 3, Month 6, & Month 9.
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.
Time frame: Baseline, within three days of completing initial open-label tDCS intervention, Month 3, Month 6, & Month 9.
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.
Time frame: Baseline, within three days of completing initial open-label tDCS intervention, Month 3, Month 6, & Month 9.
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).
Time frame: Baseline, Month 3, & Month 6
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.
Time frame: Baseline, Month 3, & Month 6
7-day accelerometry-based physical activity
This metric assesses the quantity and quality of habitual, real-world physical activity.
Time frame: Baseline, within three days of completing initial open-label tDCS intervention, Month 3, Month 6, & Month 9.
Plan to share: Yes — De-identified demographic, cognitive, motor, clinical, gait kinematics, free-living accelerometry, functional near infrared spectroscopy (fNIRS), MRI, and trial compliance and safety data
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Sharing of clinical trial data (participant level and summary level data, raw and processed) is expected at the time of publication of the primary results or within 9 months of database lock, whichever comes first. At minimum, per HSL's Record Management, Retention, Disposition and Destruction Policy, all data will be retained for at least seven years after project completion or the sponsored award agreement end date as stipulated in its terms and conditions.
Access criteria: De-identified data and all metadata will be archived within the Marcus Institute Data Archiving Service (MIDAS), a publicly accessible website built on the CKAN (Comprehensive Knowledge Archive Network) open-source data management platform. The MIDAS system is maintained and hosted by Hebrew SeniorLife. Access to scientific data will be controlled prior to publication of the primary results or for 9 months following database lock, whichever comes first. During this period, the project PI will maintain and chair a standing subcommittee of the project investigators which will review each request. Upon majority approval of a request, access to the data may be granted in secure fashion. After this period, archived data will be accessible by investigators without need of approval by the study team. Moreover, investigators who wish to access data will not need to be affiliated with HSL. Data containing patient identifiers or related sensitive fields will be archived on HSL private servers.
Data sharing details ↗ · www.marcusinstituteforaging.org
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Started Sep 2025 (actual). Primary completion is estimated for Mar 2029, 42 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 42 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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