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NCT06821568Recruiting

Home-Based Brain Stimulation for Motoric Cognitive Risk Syndrome

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

Source: ClinicalTrials.gov · Last updated 16 Jul 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
128 (estimated)
First submitted
5 Feb 2025
Start date
2 Sept 2025
Primary completion date
Mar 2029
Lead sponsor
Hebrew SeniorLife
NCT number
NCT06821568

What you commit to

  • Study type: Interventional
  • Planned participants: 128
  • From 2 Sept 2025 to the primary completion date, Mar 2029
  • 2 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous physician diagnosis of dementia
  • Active cancer for which chemo-/radiation therapy is being received

Other illness

  • Any current diagnosis of a major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depressive disorder)
  • 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
  • Myocardial infarction within the past 6 months
  • 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.

Other

  • Formal education less than the 8th grade
  • Evidence of moderate-to-severe depressive symptoms defined by a score of ≥9 on the 15-item Geriatric Depression Scale
  • 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
  • Legal blindness
  • Visual hallucinations (history or self-report)
  • Pacemaker

Who the study is looking for

  • 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

Age in the registry: 65 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tel-Aviv Sourasky Medical Center
Coordinator of this site? Confirm its status
Tel AvivIsraelRecruiting
Hebrew Rehabilitation Center
Coordinator of this site? Confirm its status
RoslindaleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.