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NCT Number: NCT05864313

Gaze and Gait Training With rTMS

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The study plan is to recruit a total of 15 cognitively impaired and 15 healthy adults. The study will involve two visits. Each study visit will involve:

  • Real rTMS or sham rTMS that last about 60 minutes
  • Gaze stabilization exercise via a virtual reality headset for about 1-hour
  • Target stepping on a treadmill for about 1-hour

Researchers will compare changes in gaze and gait following training sessions with real rTMS and sham rTMS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 - 80 years
  • Capable of providing informed consent and complying to the experimental procedures

Exclusion criteria

  • Significant gait difficulty requiring ambulatory aids
  • Presence of implanted device such as a neurostimulator, cochlear implant or pacemaker
  • History of epilepsy
  • History of hearing issues

Treatment and study plan

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,

Other names: 10 Hz rTMS FEF

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.

Primary outcomes

  1. Change in Foot Placement Error from baseline 1

    Time frame: Beginning and end of Visit 1, an average of 8 hours

    Foot position relative to stepping targets.

  2. Change in VOR Gain from baseline 1

    Time frame: Beginning and end of Visit 1, an average of 8 hours

    The amount of eye relative to head movement during active head rotations.

  3. Change in Foot Placement Error from baseline 2

    Time frame: Beginning and end of Visit 2, an average of 8 hours

    Foot position relative to stepping targets.

  4. Change in VOR Gain from baseline 2

    Time frame: Beginning and end of Visit 2, an average of 8 hours

    The amount of eye relative to head movement during active head rotations.

Secondary outcomes

  1. Change in Timed Up and Go (TUG) from baseline 1

    Time frame: Beginning and end of Visit 1, an average of 8 hours

    The TUG assesses mobility, balance, waking ability and fall risk in older adults.

    A higher risk for falling is indicated by >= 12 seconds to complete the test.

  2. Change in Timed Up and Go (TUG) from baseline 2

    Time frame: Beginning and end of Visit 2, an average of 8 hours

    The TUG assesses mobility, balance, waking ability and fall risk in older adults.

    A higher risk for falling is indicated by >= 12 seconds to complete the test.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Gaze and Gait Training With Neuromodulation

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
May 18, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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