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Trials / Completed

CompletedNCT04295798

Optimizing tDCS to Improve Dual Task Gait and Balance

Optimizing Transcranial Direct Current Stimulation (tDCS) to Improve Dual Task Gait and Balance in Older Adults

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
29 (actual)
Sponsor
Hebrew SeniorLife · Academic / Other
Sex
All
Age
65 Years – 85 Years
Healthy volunteers
Accepted

Summary

The objective of this study is to determine the acute effects of single sessions of optimized tDCS, conventional tDCS, and sham stimulation on dual task standing and walking in older adults who are free of overt disease yet who present with poor baseline dual task performance.

Detailed description

Standing and walking are almost always completed in unison with other cognitive tasks such as talking, reading or making decisions. The ability to perform this important type of "dual tasking" is critical to daily activities and dependent upon one's capacity to effectively activate appropriate brain networks that include the left dorsolateral prefrontal cortex (dlPFC). Transcranial direct current stimulation (tDCS) is a safe, noninvasive technology that can selectively modulate brain excitability (i.e., the likelihood of activation) by passing low-level currents between electrodes placed upon the scalp. We have demonstrated through a series of studies that a single, 20-minute exposure of 'conventional' tDCS targeting the left dlPFC-administered via two large sponge electrodes-reduces dual task costs to metrics of standing postural control and gait, when tested immediately following stimulation. Still, we and others have also observed relatively high between-subject variability in the effects of this conventional bipolar form of tDCS. We contend that this variability in effectiveness arises in part from relatively diffuse and unspecific current flow when using large sponge electrodes, in combination with individual variability in head and brain anatomy that significantly alters current flow and the generated electric field in the target brain region. In this project, we will 1) apply recent advances in tDCS modeling and administration to model the electric fields generated by conventional tDCS in older adults using their individual structural brain MRIs, and 2) develop and test an multi-channel tDCS montage designed to optimize current flow to the left dlPFC (i.e., 'optimized' tDCS). Our Specific Aim is to examine the immediate after-effects of conventional tDCS, optimized tDCS, and sham stimulation on dual task standing and walking in older adults. Our study population will be older men and women without overt disease or illness, yet with poor baseline dual task performance defined as a dual task cost (i.e., reduction) to gait speed of at least 10% induced by simultaneously performing a serial subtraction task when walking. We hypothesize that across participants, the effect of conventional tDCS on dual task standing and walking performance will correlate with a specific component of the electric field generated over the left dlPFC target. We also hypothesize that optimized tDCS will induce A) greater effects on dual task standing and walking performance as compared to conventional tDCS and sham stimulation, and B) these effects will be more consistent across individuals as compared to conventional tDCS. This project will provide important insights into tDCS "dosage" that will enable us and many other researchers to better understand, control, and optimize this form of noninvasive brain stimulation to individual head and brain anatomy. It is also expected to demonstrate that optimized tDCS, as compared to the conventional approach, significantly improves the size and consistency of observed benefits to dual task standing and walking in vulnerable older adults.

Conditions

Interventions

TypeNameDescription
DEVICEConventional tDCSThe anode will be placed over F3 and the cathode over the contralateral supraorbital margin. At the beginning of stimulation, the current will be increased from 0.1 mA, in 0.1 mA increments over 60 seconds, up to a maximum of 1.8 mA. At the end of each session, current will be automatically ramped down to 0.0 mA over a 60 second period.
DEVICEOptimized tDCSThis intervention will utilize eight gel electrodes with placement and current parameters optimized to the cohort, with the goal of generating an average nE over the left dlPFC of the same size as the one delivered by a conventional montage using sponges. The direct current delivered by any one electrode will however never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20- minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
DEVICEConventional ShamConventional sham will be used to maximize blinding of conventional sponge-based stimulation. The same sponge placement, ramp-up procedure, and session duration described above will be used; however, current will be automatically ramped down 60 seconds after ramp-up.
DEVICEOptimized ShamAn active sham will be used in which very low-level currents (0.5 mA max) are transferred between the same electrodes used in the active condition throughout the entire 20-minute session. This intervention will be optimized to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS. We have shown that this active sham effectively blinds participants and operators to stimulation condition and does not affect functional outcomes.

Timeline

Start date
2020-02-10
Primary completion
2023-03-02
Completion
2023-03-02
First posted
2020-03-05
Last updated
2025-01-30
Results posted
2025-01-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04295798. Inclusion in this directory is not an endorsement.