Mild Cognitive ImpairmentNCT05864313
Gaze and Gait Training With rTMS
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS), Gait training and Gaze training in people with Mild Cognitive Impairment, run by University of Florida.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS), Gait training and Gaze training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 80 years
- Capable of providing informed consent and complying to the experimental procedures
Who cannot join
- 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
About this study
Official title: Gaze and Gait Training With Neuromodulation
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), Gait training, Gaze training, Sham rTMS
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Also called 10 Hz rTMS FEF
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,
Gait trainingBehavioural
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 trainingBehavioural
Subjects will perform gaze stabilization and gaze shifting exercise via a virtual reality headset.
Sham rTMSDevice
Sham rTMS stimulation will produce discharge noise and vibration without stimulating the cerebral cortex.
| Study group | Role | What they receive |
|---|---|---|
| Real 10 Hz rTMS | Active comparator | Participants will receive 1 hour of real rTMS followed by 1 hour of gaze and gait training. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Gait training; Behavioral: Gaze training |
| sham rTMS | Sham comparator | Participants will receive 1 hour of sham rTMS followed by 1 hour of gaze and gait training. Receives: Behavioral: Gait training; Behavioral: Gaze training; Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Foot Placement Error from baseline 1
Foot position relative to stepping targets.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Beginning and end of Visit 2, an average of 8 hours
Secondary outcomes (2)
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.
Measured: 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.
Measured: Beginning and end of Visit 2, an average of 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study startJan 2027 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Choi, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864313
- Sponsor's protocol ID
- IRB202300184
- Status last verified
- Feb 2026
- First submitted
- 20 Mar 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaze and Gait Training With Neuromodulation
- ClinicalTrials.gov ID
- NCT05864313
- Acronym / sponsor ID
- IRB202300184
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real 10 Hz rTMS | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Behavioral: Gait training, Behavioral: Gaze trainingParticipants will receive 1 hour of real rTMS followed by 1 hour of gaze and gait training. |
| sham rTMS | Sham comparator | Behavioral: Gait training, Behavioral: Gaze training, Device: Sham rTMSParticipants will receive 1 hour of sham rTMS followed by 1 hour of gaze and gait training. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 - 80 years
- Capable of providing informed consent and complying to the experimental procedures
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)Also: 10 Hz rTMS FEF10 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, | Device | Real 10 Hz rTMS |
| Gait trainingSubjects will practice stepping on virtual targets with real-time feedback of their foot position displayed on a screen while walking on a treadmill. | Behavioural | Real 10 Hz rTMS, sham rTMS |
| Gaze trainingSubjects will perform gaze stabilization and gaze shifting exercise via a virtual reality headset. | Behavioural | Real 10 Hz rTMS, sham rTMS |
| Sham rTMSSham rTMS stimulation will produce discharge noise and vibration without stimulating the cerebral cortex. | Device | sham rTMS |
Primary outcome
Change in Foot Placement Error from baseline 1
Time frame: Beginning and end of Visit 1, an average of 8 hours
Foot position relative to stepping targets.
Change in VOR Gain from baseline 1
Time frame: 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
Time frame: Beginning and end of Visit 2, an average of 8 hours
Foot position relative to stepping targets.
Change in VOR Gain from baseline 2
Time frame: Beginning and end of Visit 2, an average of 8 hours
The amount of eye relative to head movement during active head rotations.
2 secondary outcomes
Change in Timed Up and Go (TUG) from baseline 1
Time frame: Beginning and end of Visit 1, an average of 8 hours
Change in Timed Up and Go (TUG) from baseline 2
Time frame: Beginning and end of Visit 2, an average of 8 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia Choi, Ph.D. principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS), Gait training and Gaze training in people with Mild Cognitive Impairment, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Foot Placement Error from baseline 1 (time frame: Beginning and end of Visit 1, an average of 8 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.