Gaze and Gait Training With rTMS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Repetitive Transcranial Magnetic Stimulation (rTMS), Gait training, Gaze training, Sham rTMS.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Gaze and Gait Training With Neuromodulation
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Change in Foot Placement Error from baseline 1 [Time frame: Beginning and end of Visit 1, an average of 8 hours]
- Change in VOR Gain from baseline 1 [Time frame: Beginning and end of Visit 1, an average of 8 hours]
- Change in Foot Placement Error from baseline 2 [Time frame: Beginning and end of Visit 2, an average of 8 hours]
- Change in VOR Gain from baseline 2 [Time frame: Beginning and end of Visit 2, an average of 8 hours]
Secondary outcome measures (2)
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05864313 · IRB202300184