Dual-target, High-dose, Transcranial Magnetic Stimulation for Parkinson's Disease With Freezing of Gait
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The Freezing of Gait Questionnaire (FOGQ) scores
研究概览
简要总结
The aim of the current study was to verify whether high-dose TMS treatment of the motor and cognitive cortices is more effective in alleviating FOG than conventional-dose TMS of the motor cortex only. Specifically, investigator hypothesized that the effect of dual-target TMS on FOG is better than traditional stimulation of the motor cortex only, and the effect of high-dose TMS is better than conventional doses.
详细描述
This was an open-label, randomized controlled study. Participants were randomized in a 1:1:1 fashion to receive dual-target, high-dose TMS (DHT), dual-target, conventional-dose TMS (DCT), and single-target, conventional-dose TMS (SCT). SCT was designated as the control group with protocol reference to evidence-based guidelines, while DHT and DCT served as the experimental groups.
DHT refers to the left primary motor cortex of the lower leg (M1) and dorsolateral prefrontal cortex (DLPFC) receiving 9000 pulses/day of intermittent TBS (iTBS) for 5 consecutive days. DCT refers to the left M1 and DLPFC receiving 1800 pulses/day of iTBS for 5 consecutive days. The order of stimulation for the two targets was randomized across participants and the order of stimulation within participants remained unchanged throughout the session. SCT refers to the left M1 receiving 1800 pulses/day of iTBS treatment for 5 consecutive days.
Motor and cognitive measures were performed ("on medication" state) 1 day before TMS (baseline), 1 day after completion of TMS (post), and 1 month after completion of TMS (follow-up). The primary outcome of this study was the change in FOGQ scores from baseline to follow-up. Secondary outcomes included changes in the Unified Parkinson's Disease Rating Scale Part III (UPDRS III), 5 m Timed Up-and-Go test (TUG), FOG-provoking test (Standing-Start 180° Turn Test, SS-180), Stroop color-naming (SCN), Stroop word-reading (SWR), Stroop color-word (SCW), and Color Trails Test interference index (CTTII) from baseline to follow-up.
Evaluate the patient's brain function and structural changes by collecting Rest-EEG，transcranial magnetic stimulation-EEG, near-infrared functional brain imaging (fNIRS）and fMRI.
TMS was performed using a Magstim Rapid2 transcranial magnetic stimulator (Magstim Company, Whitland, UK) with a 70-mm air-cooled figure-of-eight coil. All stimulations were guided by the participant's anatomical image (1 × 1 × 1 mm3) and a frameless neuronavigation system (Brainsight; Rogue Research, Montreal, QC, Canada).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 Freezing of Gait Questionnaire (FOGQ) scores
时间窗: the changes in FOGQ scores from baseline to 1 month after completion of TMS (follow-up).
This is an very common clinical motor estimating scale for evaluating FOG. 6 items and each item scored between 0 and 4 points (24 scores in total). Higher scores mean a worse outcome
次要结局
- The timed up and go test (TUG)(changes from baseline to 1 month after completion of TMS (follow-up).)
- Unified Parkinson's Disease Rating Scale III (UPDRSIII) scores(changes from baseline to 1 month after completion of TMS (follow-up).)
- Color Trails Test interference index (CTTII)(changes rom baseline to 1 month after completion of TMS (follow-up).)
- Stroop test(changes (SCN, SWR, SCW) from baseline to 1 month after completion of TMS (follow-up).)
- The Standing-Start 180° Turn Test (SS-180)(changes from baseline to 1 month after completion of TMS (follow-up).)
研究者
WANG KAI
Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC
Anhui Medical University