Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06008431
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-08
First Post:
2023-08-18
Brief Title:
Non-invasive Brain Stimulation to Improve Unsteady Gait in Older Adults StimGait
Sponsor:
Hebrew SeniorLife
Organization:
Hebrew SeniorLife
Study Overview
Official Title:
Modulating Brain Networks to Reduce Gait Variability in Older Adults at Risk of Falling
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K01AG075252 | NIH | None | httpsreporternihgovquickSearchK01AG075252 |