Gaze and Gait Training With Neuromodulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Change in Foot Placement Error from baseline 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 80 years
- •Capable of providing informed consent and complying to the experimental procedures
排除标准
- •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
研究组 & 干预措施
Real 10 Hz rTMS
Participants will receive 1 hour of real rTMS followed by 1 hour of gaze and gait training.
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
Real 10 Hz rTMS
Participants will receive 1 hour of real rTMS followed by 1 hour of gaze and gait training.
干预措施: Gait training (Behavioral)
Real 10 Hz rTMS
Participants will receive 1 hour of real rTMS followed by 1 hour of gaze and gait training.
干预措施: Gaze training (Behavioral)
sham rTMS
Participants will receive 1 hour of sham rTMS followed by 1 hour of gaze and gait training.
干预措施: Gait training (Behavioral)
sham rTMS
Participants will receive 1 hour of sham rTMS followed by 1 hour of gaze and gait training.
干预措施: Gaze training (Behavioral)
sham rTMS
Participants will receive 1 hour of sham rTMS followed by 1 hour of gaze and gait training.
干预措施: Sham rTMS (Device)
结局指标
主要结局
Change in Foot Placement Error from baseline 2
时间窗: Beginning and end of Visit 2, an average of 8 hours
Foot position relative to stepping targets.
Change in VOR Gain from baseline 2
时间窗: 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
时间窗: Beginning and end of Visit 1, an average of 8 hours
Foot position relative to stepping targets.
Change in VOR Gain from baseline 1
时间窗: Beginning and end of Visit 1, an average of 8 hours
The amount of eye relative to head movement during active head rotations.
次要结局
- Change in Timed Up and Go (TUG) from baseline 2(Beginning and end of Visit 2, an average of 8 hours)
- Change in Timed Up and Go (TUG) from baseline 1(Beginning and end of Visit 1, an average of 8 hours)