RECRUITING

Home-Based Brain Stimulation for Motoric Cognitive Risk Syndrome

Conditions

Alzheimer Disease and Related Dementias Cognition Mobility Disability 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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-07-31

Study Completion:2029-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06821568

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Katie Baldyga, BA

CONTACT

617-971-5380

Kathrynbaldyga@hsl.harvard.edu

Juhi Salecha, MS

CONTACT

617-971-5398

JuhiSalecha@hsl.harvard.edu

Principal Investigator

Brad Manor, PhD

PRINCIPAL_INVESTIGATOR

Hebrew SeniorLife

Jeff Hausdorff, PhD

PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Study Locations (Sites)

Hebrew Rehabilitation Center

Roslindale, Massachusetts, 02131

United States

Collaborators and Investigators

Sponsor: Hebrew SeniorLife

Brad Manor, PhD, PRINCIPAL_INVESTIGATOR, Hebrew SeniorLife
Jeff Hausdorff, PhD, PRINCIPAL_INVESTIGATOR, Tel-Aviv Sourasky Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-31

Study Completion Date2029-06

Study Record Updates

Study Start Date2025-07-31

Study Completion Date2029-06

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Alzheimer Disease and Related Dementias
Cognition
Mobility Disability