Gaze and Gait Training With rTMS

Sponsor
University of Florida
Study ID
NCT05864313
Status
Not Yet Recruiting

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Conditions

  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Repetitive Transcranial Magnetic Stimulation (rTMS) — DEVICE
    10 Hz rTMS for 5 seconds over the frontal eye fields with 25 second intertrain interval for 10 trains (500 pulses) at 90% of the resting motor threshold,
  • Gait training — BEHAVIORAL
    Subjects will practice stepping on virtual targets with real-time feedback of their foot position displayed on a screen while walking on a treadmill.
  • Gaze training — BEHAVIORAL
    Subjects will perform gaze stabilization and gaze shifting exercise via a virtual reality headset.
  • Sham rTMS — DEVICE
    Sham rTMS stimulation will produce discharge noise and vibration without stimulating the cerebral cortex.

Study Details

The purpose of this study is to evaluate the feasibility of combining repetitive transcranial magnetic stimulation (rTMS), gaze and gait training to improve walking and balance in people with or without mild cognitive impairment.

Key Dates

First listed
May 18, 2023
Start date
Jan 31, 2027
Status verified
Feb 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Real 10 Hz rTMS
    Participants will receive 1 hour of real rTMS followed by 1 hour of gaze and gait training.
  • Sham Comparator: sham rTMS
    Participants will receive 1 hour of sham rTMS followed by 1 hour of gaze and gait training.

Primary Outcome Measure

Change in Foot Placement Error from baseline 1 [ Time Frame: Beginning and end of Visit 1, an average of 8 hours ]

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