Neuromodulation of Central Sensory Integration to Improve Postural Control: A Pilot Study in Older Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Equilibrium Score on Sensory Organization Test
研究概览
简要总结
The objective is to evaluate if neuromodulation of the PFC can acutely improve sensory integration for balance performance in OTTBCS.
详细描述
Sensory integration required for balance will be measured using the sensory organization test which includes six conditions in which visual and proprioceptive sensory cues are sequentially referenced (i.e. reduced) to stress available sensory information and sensory integration for postural control. Performance on the sensory organization test has been correlated with falls and successful response to balance perturbation. Balance performance will be evaluated by postural sway. Cognitive function will be assessed using the NIH toolbox with a focus on executive function. tDCS will be used to modify PFC excitability and measure its immediate after-effect on balance performance while performing the sensory organization test in OTTBCS. CIPN severity will be evaluated using measurements of distal proprioception. The study sample will be older breast cancer survivors (n=20) diagnosed and treated with taxane chemotherapy after the age of 60 years to avoid heterogeneity due to multiple cancer types, treatments, and sexes.
Outcome measure were removed. Remaining outcome measures were ones that were assessed both before and after tDCS.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Those who receive tDCS on Visit 1 will receive sham stimulation on Visit 2, and those who receive sham on Visit 21and will receive tDCS stimulation on Visit 2. The order of tDCS and sham stimulation is randomized so half of the participants will receive active tDCS first and half will receive tDCS sham. The study member will also be blinded to delivering active or sham tDCS to the participant.
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Equilibrium Score on Sensory Organization Test
时间窗: 8 months
The primary outcome measure of Aim 2 will be the change in composite equilibrium score from before and immediately after a single exposure of tDCS or sham stimulation. Briefly, equilibrium score is assessment of postural sway, which can range from 0 to 100, where a lower score indicates more sway and a zero indicates a fall.
次要结局
- Trail Making B test(2 months)
- Digit Symbol Substitution Test(2 months)
- Digit Symbol Substitution Test(2 months)
- Trail Making B test(2 months)
研究者
Brendan McNeish, MD
Assistant Professor
University of Pittsburgh