Home-Based Brain Stimulation for Motoric Cognitive Risk Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-90
SponsorHebrew SeniorLife
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Personalized Transcranial Direct Current Stimulation (tDCS)
Other interventionHome-based transcranial direct current stimulation (tDCS) tailored to target the left dlPFC.
Active-Sham
Other interventionStimulation 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.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Personalized Transcranial Direct Current Stimulation (tDCS)Experimental treatment 1 intervention
Group B: Combination Arm; Sham Plus Personalized Transcranial Direct Current Stimulation (tDCS)Active comparator 2 interventions
Trial outcomes
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.
Time frame
Pre-randomization baseline; within three days of completing the initial open-label tDCS intervention; Month 3, Month 6; Month 9.Secondary outcomes
1
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 9.2
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 9.3
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 9.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hebrew SeniorLife
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Tel Aviv Medical Center
Collaborator
Source ClinicalTrials.gov