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).
In older adults, motoric cognitive risk (MCR) is a pre-dementia transition state between "normal" aging and dementia. MCR is associated with impaired function within several brain networks that causes numerous symptoms including loss of memory, the ability to complete complex mental tasks, and the capacity to control one's walking and thus avoid falling and fall-related injuries. This study seeks to assess the short-term and long-term use of an investigational device called a transcranial direct current stimulation (tDCS). tDCS is a noninvasive technology that enables selective modulation of brain network function, to provide multi-symptom relief to older adults with MCR. By using state-of-the-art technology to 1) utilize a personalized tDCS intervention via an established optimization approach using individual brain MRIs, and 2) complete stimulation in a home-based setting, this study is expected to result in the development of tDCS interventions that have maximal impact on daily life function within this population. In this study, investigators will conduct a 9-month sham-controlled, double-blinded, multi-site trial in 128 older adults aged 65-90 years old with MCR. All enrolled participants will complete an open-label 2-week, 10-session tDCS intervention. During the open-label phase of the study, all participants will receive active tDCS. Then, participants will be randomly assigned into either the tDCS arm that receives five weekly tDCS sessions for 6 months, or a combination arm of five weekly tDCS sessions for 3 months before or after five weekly sessions of sham for 3 months. Sham treatment is similar to the study tDCS treatment, but omits the key therapeutic element of the treatment being studied. Participants in the combination arm will not know whether they are receiving tDCS or sham during the first or second 3-month period. Enrolled participants will complete assessments relating to cognition, mood, balance, and memory at baseline, after the 2-week open-label phase, after 3 and 6 months of tDCS, and again 3 months later. Once a week, participants will also complete a gait (walking) assessment at home. MRI scans will be performed at baseline and after completing 3 months of tDCS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
128
Home-based transcranial direct current stimulation (tDCS) tailored to target the left dlPFC.
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.
Hebrew Rehabilitation Center
Roslindale, Massachusetts, United States
RECRUITINGTel Aviv Sourasky Medical Center
Tel Aviv, Israel
RECRUITINGDual 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.
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.
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.
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.
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.
The change in left prefrontal deoxygenated hemoglobin between standing and usual walking
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This metric is measured using functional near-infrared spectroscopy (fNIRS) and reflects one aspect of brain activation induced by performing the task of usual walking and preferred speed.
Time frame: Baseline, within three days of completing initial open-label tDCS intervention, Month 3, Month 6, & Month 9.
Left dorsolateral prefrontal cortex (dlPFC) gray matter volume
This metric quantifies the volume of gray matter within the left dorsolateral prefrontal cortex (the brain target-of-interest for the tDCS intervention).
Time frame: Baseline & Month 3
Left dorsolateral prefrontal cortex (dlPFC) functional connectivity
This metric quantifies the strength of functional connectivity between the left dorsolateral prefrontal cortex (the brain target-of-interest for the tDCS intervention) and the rest of the brain.
Time frame: Baseline & Month 3
7-day accelerometry-based physical activity
This metric assesses the quantity and quality of habitual, real-world physical activity.
Time frame: Baseline, within three days of completing initial open-label tDCS intervention, Month 3, Month 6, & Month 9.