Gaze and Gait Training With rTMS

Study Overview
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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.

Official Title
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Gaze and Gait Training With Neuromodulation

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
* Behavioral: Gait training
* Behavioral: Gaze training
* Device: Sham rTMS


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real 10 Hz rTMS<br>Participants will receive 1 hour of real rTMS followed by 1 hour of gaze and gait training. | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)<br>* 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,<br>* Other names: 10 Hz rTMS FEF;Behavioral: Gait training<br>* Subjects will practice stepping on virtual targets with real-time feedback of their foot position displayed on a screen while walking on a treadmill.<br>Behavioral: Gaze training<br>* Subjects will perform gaze stabilization and gaze shifting exercise via a virtual reality headset.<br>|
| Sham Comparator: sham rTMS<br>Participants will receive 1 hour of sham rTMS followed by 1 hour of gaze and gait training. | Behavioral: Gait training<br>* Subjects will practice stepping on virtual targets with real-time feedback of their foot position displayed on a screen while walking on a treadmill.<br>Behavioral: Gaze training<br>* Subjects will perform gaze stabilization and gaze shifting exercise via a virtual reality headset.<br>Device: Sham rTMS<br>* Sham rTMS stimulation will produce discharge noise and vibration without stimulating the cerebral cortex.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Foot Placement Error from baseline 1 | Foot position relative to stepping targets. | Beginning and end of Visit 1, an average of 8 hours | 
| Change in VOR Gain from baseline 1 | 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 | Foot position relative to stepping targets. | Beginning and end of Visit 2, an average of 8 hours | 
| Change in VOR Gain from baseline 2 | 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 | 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 | 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 |