Personalized home brain stimulation to help thinking and walking in older adults with motoric cognitive risk
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
This trial tests whether personalized, home-based transcranial direct current stimulation (tDCS) can improve thinking and walking in people aged 65–90 who have motoric cognitive risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 65 Years to 90 Years |
| Sex | All |
| Sponsor | Hebrew SeniorLife Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Roslindale, Massachusetts and 1 other locations) |
| Trial ID | NCT06821568 on ClinicalTrials.gov |
What this trial studies
This is a 9-month, double-blind, sham-controlled, multi-site trial enrolling 128 older adults with motoric cognitive risk syndrome. All participants first receive a 2-week, 10-session open-label course of individualized tDCS tailored using each person’s brain MRI, delivered in the home by a study partner. After the open-label phase, participants are randomized to receive ongoing weekly active tDCS sessions for six months or a sham (placebo) maintenance regimen. Primary outcomes include cognitive function, dual-task standing and walking performance, and other measures of mobility and daily function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65–90 with subjective cognitive complaints, MoCA score ≥21, slow gait speed but no significant disability, an identified informant, and a willing study partner to administer home-based tDCS.
Not a fit: People with more advanced cognitive impairment (MoCA <21), significant mobility disability requiring walking aids, no available study partner, or contraindications to tDCS are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could improve memory and the ability to safely walk and multitask, potentially lowering fall risk and preserving independence in older adults with MCR.
How similar studies have performed: Prior small and pilot studies of tDCS for cognition and mobility have shown mixed but promising signals, while personalized MRI-guided, home-based tDCS remains a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Roslindale, Massachusetts and 1 other locations
- Hebrew Rehabilitation Center — Roslindale, Massachusetts, United States (Recruiting)
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (Recruiting)
Study contacts
- Principal investigator: Brad Manor, PhD — Hebrew SeniorLife
- Study coordinator: Katie Baldyga, BA
- Email: Kathrynbaldyga@hsl.harvard.edu
- Phone: 617-971-5380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.