jRCT1080224083已完成3 期
double-blind randomized placebo-controlled cross over clinical trial to confirm the safety and the effectiveness of noisy galvanic vestibular stimulation to improve postural stability in patients with refractory vestibular dysfunction with severe postural instability
Department of Otolaryngology-Head and Neck Surgery, University of Tokyo Hospital1 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes from the baseline in the total path length measured by the stabilometer
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- This is a double-blind randomized placebo-controlled cross over clinical trial. Subjects who provide their informed consent and are confirmed to be eligible will be provisionally enrolled. Among them, only the subjects confirmed to have optimal stimulation in its examination will be enrolled. Subjects who have no optimal stimulation will be excluded from the trial at this point and safety is confirmed 2 weeks later. The enrolled subjects will be randomly allocated to two groups. One group will be first evaluated for the effect of noisy GVS for 4-h stimulation, then the placebo stimulation 2 weeks later, as well as the effect of repetitive stimulation. The other group will be evaluated for the effect of placebo stimulation, then the effect of noisy GVS for 4-h stimulation. These 2 groups were allocated 1:1 ratio randomly. The enrollment and the first visit is at least 7 days apart.
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 85age old under（—）
- 性别
- All
入选标准
- •unilateral or bilateral vestibular dysfunction as revealed by caloric test
- •Unilateral vestibular dysfunction is defined as CP (Canal paresis) = (Maximal slow phase velocity (MSPV) of the healthy ear - MSPV of the diseased ear)/ (MSPV of healthy ear + MSPV of diseased ear)x 100 > 20%. Bilateral vestibular dysfunction is defined as MSPV of both ears < 10 deg/sec.
- •The total path length of center of pressure is > 180 cm/ 60 s during two legged stance with eyes-closed condition
- •Dizziness continue > 1 y, vestibular rehabilitation > 6 m.
- •Age between 20 y and 85 y
- •Participants must understand the content of the trial and agree with the participation by their own will.
排除标准
- •Metal in the body, including intracephalic aneurysm clips and pace makers
- •Orthopedic disease
- •Motor dysfunction caused cerebellar or spinal disease
- •Heart disease
- •A malignant tumor
- •Acute infection
- •Pregnant or just after delivery
- •Inability to walk without assistance
- •Skin abnormality on mastoids
- •Medicated by any tranquilizers and/or antidepressants
- •Consumed alcohol after 10 PM the day prior to the trial
- •Deemed not eligible by the investigator (co-investigator)
结局指标
主要结局
Changes from the baseline in the total path length measured by the stabilometer
时间窗: 0 h, 0.5 h, 1 h, 2 h, and 3 h after the onset of the stimulus
1) Descriptive statistics are calculated for the value and the changes in the total path length at all measurement points in each group. Then those values are calculated in the combined group. Those values are also calculated in each subject and compared using t-test. 2) The averaged value of the changes in the total path length from just after the start of noisy GVS to 3-h after the start and those value of placebo stimulus are compared using paired t-test.
次要结局
- safety
- Changes from the baseline in the envelopment area and the RMS of the center of pressure(0 h, 0.5 h, 1 h, 2 h, and 3 h after the onset of the stimulus.)
- Changes in the total path length, the envelopment area and the RMS of COP(4 h, 5 h, 6 h, and 7 h from the onset of the stimulus.)
- Gait function(0 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h after the onset of the stimulus.)
- Subjective improvement score(0 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h after the onset of the stimulus.)
- Quality of Life (QOL)(3 h and 7 h after the onset of the stimulus.)
- Activity(3 h and 7 h after the onset of the stimulus.)
研究者
研究点 (1)
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