NCT06008431

Non-invasive Brain Stimulation to Improve Unsteady Gait in Older Adults (StimGait)

Modulating Brain Networks to Reduce Gait Variability in Older Adults at Risk of Falling

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Hebrew SeniorLife · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

Walking is a complex and continuous task that entails repetitive motions of the body. Relatively high gait variability sensitively predicts falls and cognitive decline in older adults. Previous work has identified an unique brain network relationship linked to gait variability and its relevant cognitive function (i.e., sustained attention). This project aims to develop a non-invasive brain stimulation montage designed to modulate the shared brain networks dynamics and to demonstrate its effects on resting state functional connectivity, gait and cognitive performance in older adults at risk for falls.

Detailed description

This is a randomized controlled trial to examine the efficacy of a non-invasive brain stimulation intervention of tDCS to improve unsteady gait in older adults. The investigators will enroll 30 older adults with elevated gait variability. Participants will be randomized into one of two arms: a) 10 sessions of tDCS and b) 5 sessions of sham stimulation followed by 5 sessions of tDCS. Participants will engage in a set of pre-intervention assessments, the brain stimulation intervention - consisting of 10, once-daily, 20-min stimulation sessions over a 2-week period, and a set of post-intervention assessments. This project is expected to demonstrate that tDCS can be used to reduce gait variability in older adults.

Conditions

• Fall
• Gait, Unsteady
• Mobility Limitation

Interventions

Type	Name	Description
DEVICE	Transcranial direct current stimulation (tDCS) (active)	The tDCS montage is developed to modulate the functional connectivity between the dorsal attention network and the default network.
DEVICE	Transcranial direct current stimulation (tDCS) (Sham)	The tDCS "Acti-" Sham montage is developed to recreate the cutaneous sensations associated with tDCS, yet essentially a null electrical field over the networks of interest.

Timeline

• Start date: 2024-06-03
• Primary completion: 2025-11-20
• Completion: 2025-11-20
• First posted: 2023-08-23
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study