Gaze and Gait Training With rTMS

NCT ID: NCT05864313

Last Updated: 2025-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-09-30

Study Completion Date

2028-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Real 10 Hz rTMS

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

Group Type ACTIVE_COMPARATOR

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

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

sham rTMS

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

Group Type SHAM_COMPARATOR

Gait training

Intervention Type 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

Intervention Type BEHAVIORAL

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

Sham rTMS

Intervention Type DEVICE

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

Interventions

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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,

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Gaze training

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

Intervention Type BEHAVIORAL

Sham rTMS

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

Intervention Type DEVICE

Other Intervention Names

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10 Hz rTMS FEF

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julia Choi, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Other Identifiers

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IRB202300184

Identifier Type: -

Identifier Source: org_study_id

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