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临床试验/NCT03271736
NCT03271736已完成不适用

Effects of Rhythmic Auditory Cueing on Stepping in Place in Patients With Parkinson's Disease

HsiuYun Chang2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年2月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
Changes of transcranial magnetic stimulation (TMS) parameters

研究概览

简要总结

Patients with Parkinson's disease have internal rhythm dysfunction, which may affect the rhythmic movements such as walking. Poor regularity of the rhythmic movement may lead to freezing of gait. This study will apply rhythmic auditory cues on the stepping-in-place training and the investigators will examine if the behavior and neuroelectrophysiology would change after auditory cueing training. The investigators hypothesize the variation of rhythmic movements such as walking and stepping-in-place will be reduced, and the cortical excitability would be modulated after training.

详细描述

Parkinson's disease is a common neurodegenerative disease and movement disorder. Due to the degeneration of basal ganglia, patients with Parkinson's disease also demonstrate internal rhythm dysfunction, thus will lead to difficulty in rhythmic movements such as ambulation. For improving the rhythmic movement problem, auditory cues are often used in clinical setting and shows benefits in ambulation and freezing problems. Previous studies often use finger tapping test and ambulation to assess the rhythmic movement problem. No study uses stepping in place movements as a test to examine rhythmic problem. Little study investigates the effects of auditory cues on brain cortical excitability. In this cross-over study, participants will receive 2 times of training include stepping-in-place exercise with and without auditory cues in random orders. Auditory cues are given via the metronome. There is one-week wash-out period between two trainings. Movement tests such as walking and stepping-in-place and transcranial magnetic stimulation (TMS) are carried out before and after each training.

The investigators hypothesize the variation of rhythmic movements such as walking and stepping-in-place will be reduced more, and the cortical excitability would be modulated after the training with auditory cues, comparing with the other training without auditory cues.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with idiopathic Parkinson's disease
  • No hearing impairment
  • Able to walk independently for at least 10m
  • Able to follow command (MMSE >=24)
  • [Healthy subjects]
  • No hearing impairment
  • Able to walk independently for at least 10m
  • Able to follow command (MMSE >=24)

排除标准

  • With other neurological diseases or psychological diseases
  • Family history of epilepsy
  • History of head trauma, surgery, or metal implants
  • Having pacemaker or other electrical stimulators
  • History of syncopes or frequent migraines

研究组 & 干预措施

Freezer

Experimental

All the subjects received 2 experiments. 2 experiments contain 20 mins stepping-in-place exercise and pre-/post assessments. The difference between 2 experiments is the application of auditory cues. One of the 2 experiment includes stepping-in-place exercise with auditory cues from the metronome (Stepping-in-place exercise with external auditory cues), in the other experiment we ask the subjects to follow their internal rhythm without external auditory cues (Stepping-in-place exercise without external auditory cues). Transcranial magnetic stimulation (TMS) is applied before and after the stepping-in-place exercise.

干预措施: Stepping-in-place exercise with external auditory cues (Behavioral)

Freezer

Experimental

All the subjects received 2 experiments. 2 experiments contain 20 mins stepping-in-place exercise and pre-/post assessments. The difference between 2 experiments is the application of auditory cues. One of the 2 experiment includes stepping-in-place exercise with auditory cues from the metronome (Stepping-in-place exercise with external auditory cues), in the other experiment we ask the subjects to follow their internal rhythm without external auditory cues (Stepping-in-place exercise without external auditory cues). Transcranial magnetic stimulation (TMS) is applied before and after the stepping-in-place exercise.

干预措施: Transcranial magnetic stimulation (TMS) (Device)

Non-freezer

Experimental

All the subjects received 2 experiments. 2 experiments contain 20 mins stepping-in-place exercise and pre-/post assessments. The difference between 2 experiments is the application of auditory cues. One of the 2 experiment includes stepping-in-place exercise with auditory cues from the metronome (Stepping-in-place exercise with external auditory cues), in the other experiment we ask the subjects to follow their internal rhythm without external auditory cues (Stepping-in-place exercise without external auditory cues). Transcranial magnetic stimulation (TMS) is applied before and after the stepping-in-place exercise.

干预措施: Stepping-in-place exercise with external auditory cues (Behavioral)

Non-freezer

Experimental

All the subjects received 2 experiments. 2 experiments contain 20 mins stepping-in-place exercise and pre-/post assessments. The difference between 2 experiments is the application of auditory cues. One of the 2 experiment includes stepping-in-place exercise with auditory cues from the metronome (Stepping-in-place exercise with external auditory cues), in the other experiment we ask the subjects to follow their internal rhythm without external auditory cues (Stepping-in-place exercise without external auditory cues). Transcranial magnetic stimulation (TMS) is applied before and after the stepping-in-place exercise.

干预措施: Transcranial magnetic stimulation (TMS) (Device)

结局指标

主要结局

Changes of transcranial magnetic stimulation (TMS) parameters

时间窗: TMS parameters are assessed immediately before and after a 30-minute intervention. The data will be reported through study completion, for average of 6 months.

Single-pulse and paired-pulse TMS are used to measure the cortical excitability of the motor cortex and the integrity of the intracortical inhibitory/facilitatory circuits. The TMS parameters include motor threshold (MT), motor evoke potential, silent period, short intracortical inhibition and facilitation. In single-pulse condition, the stimulation intensity is set at 130% of the MT. While in the paired-pulse condition, the first conditioning stimulus is set at 80% of MT, the second test stimulus is set at 130% of MT.

次要结局

  • Variation of walking step time(The step time variability is assessed immediately before and after a 30-minute intervention. The data will be reported through study completion, for average of 6 months.)
  • Variation of stepping-in-place movement(The step variability is assessed immediately before and after a 30-minute intervention. The data will be reported through study completion, for average of 6 months.)
  • Walking ability(The walking ability is assessed immediately before and after a 30-minute intervention. The data will be reported through study completion, for average of 6 months.)

研究者

发起方
HsiuYun Chang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

HsiuYun Chang

Principal Investigator

National Taiwan University

研究点 (2)

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