Gaze and Gait Training With rTMS

University of Florida

Status: Begins enrollment in 6 months

Conditions: Mild Cognitive Impairment

Treatments: Device: Sham rTMS; Behavioral: Gaze training; Behavioral: Gait training; Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05864313

IRB202300184

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Real 10 Hz rTMS

Active Comparator group

Description:

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

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Behavioral: Gait training

Behavioral: Gaze training

sham rTMS

Sham Comparator group

Description:

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

Treatment:

Behavioral: Gait training

Behavioral: Gaze training

Device: Sham rTMS