Gaze and Gait Training With rTMS

May 1, 2026 updated by: University of Florida

Gaze and Gait Training With Neuromodulation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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
Behavioral: Gait 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.
Behavioral: Gaze training
Subjects will perform gaze stabilization and gaze shifting exercise via a virtual reality headset.
Sham Comparator: sham rTMS
Participants will receive 1 hour of sham rTMS followed by 1 hour of gaze and gait training.
Behavioral: Gait 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.
Behavioral: Gaze training
Subjects will perform gaze stabilization and gaze shifting exercise via a virtual reality headset.
Device: Sham rTMS
Sham rTMS stimulation will produce discharge noise and vibration without stimulating the cerebral cortex.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Beginning and end of Visit 1, an average of 8 hours
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.
Beginning and end of Visit 1, an average of 8 hours
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.
Beginning and end of Visit 2, an average of 8 hours
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.
Beginning and end of Visit 2, an average of 8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Beginning and end of Visit 1, an average of 8 hours
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.
Beginning and end of Visit 2, an average of 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Julia Choi, Ph.D., University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202300184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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