Home-Based Brain Stimulation for Motoric Cognitive Risk Syndrome

NCT06821568 | Recruiting DMC

• 2 other identifiers: 000726421R01AG081349-01A1
• Study Type: interventional
• Target: 128
• Locations: 2 countries
• Sites: 2

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

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

Outcome Measures

Primary Outcomes (1)

• Dual task cost to gait speed

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

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

Secondary Outcomes (8)

• Executive function composite score

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

• Dual task gait speed

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

• Preferred gait speed

  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

  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

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

Study Arms (2)

Personalized Transcranial Direct Current Stimulation (tDCS)

EXPERIMENTAL

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)

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

ACTIVE COMPARATOR

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

Interventions

Personalized Transcranial Direct Current Stimulation (tDCS) OTHER

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

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

Active-Sham OTHER

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.

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

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebrew SeniorLife: lead
• National Institute on Aging (NIA): collaborator
• Tel Aviv Medical Center: collaborator

Study Sites (2)

Hebrew Rehabilitation Center

Roslindale, Massachusetts, 02131, United States

RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Anxiety Disorders; Atrophy; Behavior; Dementia; Cognition Disorders; Syndrome

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease; Pathologic Processes

Study Officials

• Brad Manor, PhD

  Hebrew SeniorLife

  PRINCIPAL INVESTIGATOR

• Jeff Hausdorff, PhD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Baldyga, BA

CONTACT

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

Juhi Salecha, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study personnel administering assessments, caregivers administering tDCS and the participants will not be aware of tDCS intervention arm assignment. The investigators will ensure double-blinding by programming the tDCS software with intervention-specific stimulation codes, as supplied by personnel uninvolved in data collection prior to study initiation.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientist

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 12, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

IL (1); US (1)