Gaze and Gait Training With rTMS
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
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.
|
Outcome Measures
Primary Outcome Measures
- Change in Foot Placement Error from baseline 1 [Beginning and end of Visit 1, an average of 8 hours]
Foot position relative to stepping targets.
- Change in VOR Gain from baseline 1 [Beginning and end of Visit 1, an average of 8 hours]
The amount of eye relative to head movement during active head rotations.
- Change in Foot Placement Error from baseline 2 [Beginning and end of Visit 2, an average of 8 hours]
Foot position relative to stepping targets.
- Change in VOR Gain from baseline 2 [Beginning and end of Visit 2, an average of 8 hours]
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 [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.
- Change in Timed Up and Go (TUG) from baseline 2 [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.
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Florida
Investigators
- Principal Investigator: Julia Choi, Ph.D., University of Florida
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB202300184