Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) for Freezing of Gait
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The Standing-Start 180° Turn Test (SS-180)
研究概览
简要总结
To investigate the treatment effect of Theta-burst Transcranial Magnetic Stimulation (TBS) on patients with freezing of gait (FOG) and the underlying neural mechanism.
详细描述
This was a open-label clinical trial to assess the efficacy and underlying neural mechanism of TBS among patients with FOG. Forty patients with FOG were treated with TBS for 1 week.
Before the TBS treatment, the Freezing of Gait Questionnaire, the Timed up and go test, the Standing Start 180° Turning Test, the Unified Parkinson's Disease Rating Scale, and the Non-motor Symptom Scale, the Pittsburgh sleep quality index were obtained by a trained investigator to assess baseline severity. The patients had receiving a battery measure of neuropsychological tests(mini-mental state examination, Montreal cognitive assessment, digital span test, verbal fluency test, Hamilton depression/anxiety scale) and magnetic resonance imaging (MRI) scan in multimodalities, electroencephalography (EEG) record and fNIRS.
In the second day after the last treatment, all the tests, MRI 、EEG and fNIRS were reassessed. Patients were instructed to focus their answers on the past 1 week.
The clinical symptom and cognition of participants were followed in one month and two month after the last treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of FOG with expertise in movement disorders.
- •the score of item 3 of the FOG questionnaire ≥
- •ongoing treatment with a stable dose of any medication for 2 months.
- •40 years of age or older.
排除标准
- •a history of addiction, psychiatric disorders, or neurological diseases other than PD.
- •focal brain lesions on T1-/T2-weighted fluid-attenuated inversion recovery images.
- •anti-PD medication adjustments during rTMS treatment.
- •history of substance abuse within the past 6 months.
- •nonremovable metal objects in or around the head.
- •previously received rTMS treatment.
- •prior history of seizure or history in first-degree relatives.
结局指标
主要结局
The Standing-Start 180° Turn Test (SS-180)
时间窗: changes from baseline to 1-week post-treatment
The participants walk for a distance of five meters from a sitting position and come back to the chair after turning 180° around a traffic cone in a 0.7 m × 0.7 m target box.The time and number of steps during the 180° turn (SS180) are measured.
次要结局
- Unified Parkinson's Disease Rating Scale III (UPDRSIII)(changes from baseline to 1-week post-treatment)
- The Freezing of Gait Questionnaire (FOGQ)(changes from baseline to 1-week post-treatment)
- Non-motor symptoms questionnaire(changes from baseline to 1-week post-treatment)
- HAMA (Hamilton Anxiety Scale)(changes from baseline to 1-week post-treatment)
- Pittsburgh sleep quality index (PSQI)(changes from baseline to 1-week post-treatment)
- The timed up and go test (TUG)(changes from baseline to 1-week post-treatment)
- HAMD (Hamilton Depression Scale)(changes from baseline to 1-week post-treatment)
研究者
WANG KAI
Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC
Anhui Medical University