Gaze and Gait Training With rTMS

Not Applicable

Not yet recruiting

• Conditions: Mild Cognitive Impairment
• Interventions: Behavioral: Gait training; Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Sham rTMS; Behavioral: Gaze training

• Registration Number: NCT05864313
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-22
• Study Start: 2025-09
• Primary Completion: 2028-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
sham rTMS	Gait training	Participants will receive 1 hour of sham rTMS followed by 1 hour of gaze and gait training.
sham rTMS	Sham rTMS	Participants will receive 1 hour of sham rTMS followed by 1 hour of gaze and gait training.
Real 10 Hz rTMS	Repetitive Transcranial Magnetic Stimulation (rTMS)	Participants will receive 1 hour of real rTMS followed by 1 hour of gaze and gait training.
Real 10 Hz rTMS	Gait training	Participants will receive 1 hour of real rTMS followed by 1 hour of gaze and gait training.
Real 10 Hz rTMS	Gaze training	Participants will receive 1 hour of real rTMS followed by 1 hour of gaze and gait training.
sham rTMS	Gaze training	Participants will receive 1 hour of sham rTMS followed by 1 hour of gaze and gait training.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.