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Not yet recruitingNCT05864313Updated May 6, 2026

Gaze and Gait Training With rTMS

An interventional study of Repetitive Transcranial Magnetic Stimulation (rTMS) and Gait training in Mild Cognitive Impairment, sponsored by University of Florida. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by University of Florida · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Mild Cognitive Impairment
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's planned enrollment of 30 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Real 10 Hz rTMS

    Participants will receive 1 hour of real rTMS followed by 1 hour of gaze and gait training.

    Device: Repetitive Transcranial Magnetic Stimulation (rTMS) · Behavioral: Gait training · Behavioral: Gaze training

  • Sham comparator
    sham rTMS

    Participants will receive 1 hour of sham rTMS followed by 1 hour of gaze and gait training.

    Behavioral: Gait training · Behavioral: Gaze training · Device: Sham rTMS

Interventions

  • DeviceRepetitive Transcranial Magnetic Stimulation (rTMS)

    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,

    Also known as: 10 Hz rTMS FEF

  • BehavioralGait training

    Subjects will practice stepping on virtual targets with real-time feedback of their foot position displayed on a screen while walking on a treadmill.

  • BehavioralGaze training

    Subjects will perform gaze stabilization and gaze shifting exercise via a virtual reality headset.

  • DeviceSham rTMS

    Sham rTMS stimulation will produce discharge noise and vibration without stimulating the cerebral cortex.

06

What researchers measure

Primary outcomes

  1. Change in Foot Placement Error from baseline 1

    Foot position relative to stepping targets.

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

  2. Change in VOR Gain from baseline 1

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

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

  3. Change in Foot Placement Error from baseline 2

    Foot position relative to stepping targets.

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

  4. Change in VOR Gain from baseline 2

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

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

Secondary outcomes

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

    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.

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

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

    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.

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05864313
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
May 18, 2023
Start date
Jan 2027 (estimated)
Primary completion
Sep 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
May 6, 2026

Study contacts

Julia Choi, Ph.D.
principal investigator · University of Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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