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Gaze and Gait Training With rTMS

Primary Purpose

Mild Cognitive Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Gait training
Gaze training
Sham rTMS
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mild Cognitive Impairment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Real 10 Hz rTMS

    sham rTMS

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Change in Foot Placement Error from baseline 1
    Foot position relative to stepping targets.
    Change in VOR Gain from baseline 1
    The amount of eye relative to head movement during active head rotations.
    Change in Foot Placement Error from baseline 2
    Foot position relative to stepping targets.
    Change in VOR Gain from baseline 2
    The amount of eye relative to head movement during active head rotations.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    March 20, 2023
    Last Updated
    May 8, 2023
    Sponsor
    University of Florida
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05864313
    Brief Title
    Gaze and Gait Training With rTMS
    Official Title
    Gaze and Gait Training With Neuromodulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2025 (Anticipated)
    Study Completion Date
    September 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Florida

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Real 10 Hz rTMS
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive 1 hour of real rTMS followed by 1 hour of gaze and gait training.
    Arm Title
    sham rTMS
    Arm Type
    Sham Comparator
    Arm Description
    Participants will receive 1 hour of sham rTMS followed by 1 hour of gaze and gait training.
    Intervention Type
    Device
    Intervention Name(s)
    Repetitive Transcranial Magnetic Stimulation (rTMS)
    Other Intervention Name(s)
    10 Hz rTMS FEF
    Intervention Description
    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
    Behavioral
    Intervention Name(s)
    Gait training
    Intervention Description
    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
    Intervention Name(s)
    Gaze training
    Intervention Description
    Subjects will perform gaze stabilization and gaze shifting exercise via a virtual reality headset.
    Intervention Type
    Device
    Intervention Name(s)
    Sham rTMS
    Intervention Description
    Sham rTMS stimulation will produce discharge noise and vibration without stimulating the cerebral cortex.
    Primary Outcome Measure Information:
    Title
    Change in Foot Placement Error from baseline 1
    Description
    Foot position relative to stepping targets.
    Time Frame
    Beginning and end of Visit 1, an average of 8 hours
    Title
    Change in VOR Gain from baseline 1
    Description
    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
    Title
    Change in Foot Placement Error from baseline 2
    Description
    Foot position relative to stepping targets.
    Time Frame
    Beginning and end of Visit 2, an average of 8 hours
    Title
    Change in VOR Gain from baseline 2
    Description
    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 Outcome Measure Information:
    Title
    Change in Timed Up and Go (TUG) from baseline 1
    Description
    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
    Title
    Change in Timed Up and Go (TUG) from baseline 2
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julia Choi, Ph.D.
    Organizational Affiliation
    University of Florida
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Gaze and Gait Training With rTMS

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