Gaze and Gait Training With rTMS

Mild Cognitive Impairment Clinical Trial

Official title:

Gaze and Gait Training With Neuromodulation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05864313
• Other study ID #: IRB202300184
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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,

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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