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A Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults

Study acronym: TMS MRI TBS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Secondary endpoints revised (15)
  2. Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 2 of 15 entries
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to explore the effects of intermittent theta burst stimulation (iTBS) primed with theta burst stimulation (cTBS), on top of aerobic exercise, on cognitive function, mobility, and brain activity in older adults with cognitive frailty. Understanding these effects will help us develop intervention models that benefit cognitively frail older adults. The main questions it aims to answer are: 1. Does the combination of iTBS primed with cTBS and aerobic exercise lead to greater improvements in cognition and mobility in older adults with cognitive frailty compared to non-priming iTBS and sham stimulation? 2. What are the neural mechanisms responsible for the improvements in cognition and mobility associated with the combination of iTBS primed with cTBS and aerobic exercise in older adults with cognitive frailty?
Trial Details
NCT Number NCT07497334
Lead Sponsor The Hong Kong Polytechnic University
Conditions
(from sponsor)		 Frailty at Older Adults, Mild Cognitive Impairment
Related terms Cognitive Dysfunction
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov