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临床试验/NCT05264909
NCT05264909Unknown不适用

Assessment of Transcranial Electrical Stimulation and Auditory Stimulation During Walking in Parkinson Patients

Corporación de Rehabilitación Club de Leones Cruz del Sur2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
5
试验地点
2
主要终点
Gait Deviation Index Baseline

研究概览

简要总结

Parkinson's disease affects 1 in 100 people over the age of 60. Parkinson's disease (PD) is a progressive disease of the nervous system that affects movement, produced by the destruction of dopaminergic neurons found in a region of the brain called the basal ganglia Over time, different strategies have been developed to treat and slow the progress of the disease, including pharmacological, rehabilitative and even surgical treatments.

Transcranial direct current stimulation (tDCS) is a brain stimulation technique that delivers a low-intensity electrical current to the scalp, usually between 1 and 2 mA over approximately 5 to 30 minutes. The tDCS technique is used with the aim of enhancing a specific brain activity through the neuromodulation of neuronal excitability. In pathologies such as PD, these therapies have been shown to induce immediate after-effects in the brain that translate into reduced gait freezing and improvements in executive function and mobility. In addition, the combined effects of tDCS and physical therapy on the walking ability of PD patients have been studied, where it was shown that anodic tDCS and physiotherapy could be used as a combination treatment to improve patients' gait speed.

Another potential therapeutic tool in the treatment of PD consists of the use of sound stimulation with beat frequencies similar to the step. Specifically, this technology is characterized by presenting two tones of different frequencies for each ear in order to influence the mood and mental performance of the listener.

This protocol is proposed in order to evaluate the effect of tDCS combined with auditory and binaural stimulus strategies during gait therapy in patients with Parkinson's disease.

详细描述

According to the World Health Organization (WHO), Parkinson's disease affects 1 in 100 people over the age of 60. Currently, there are about 7 million people with this disease in the world and the WHO predicts that by 2030 they will reach more than 12 million.

Parkinson's disease (PD) is a progressive disease of the nervous system that affects movement, produced by the destruction of dopaminergic neurons found in a region of the brain called the basal ganglia. This disease usually affects people over 60 years of age, whose symptoms worsen as the disease progresses and in many cases the ability to function in everyday situations is greatly affected. Due to decreased levels of dopamine, motor symptoms such as tremor, stiffness, slowness of movement, postural instability and other non-motor symptoms such as depression, hallucinations, insomnia and dysfunction of the autonomous organic systems, for example, digestion and blood pressure, as well as alteration in the expression of emotions. Over time, different strategies have been developed to treat and slow the progress of the disease, including pharmacological, rehabilitative and even surgical treatments.

Transcranial direct current stimulation (tDCS) is a brain stimulation technique that delivers a low-intensity electrical current to the scalp, usually between 1 and 2 mA over approximately 5 to 30 minutes. During tDCS, most people feel a slight tingling, pricking, itching or warmth, however, these sensations are not painful and disappear when the stimulation is stopped. The tDCS technique is used with the aim of enhancing a specific brain activity through the neuromodulation of neuronal excitability. In pathologies such as PD, these therapies have been shown to induce immediate after-effects in the brain that translate into reduced gait freezing and improvements in executive function and mobility. In addition, the combined effects of tDCS and physical therapy on the walking ability of PD patients have been studied, where it was shown that anodic tDCS and physiotherapy could be used as a combination treatment to improve patients' gait speed.

Another potential therapeutic tool in the treatment of PD consists of the use of sound stimulation with beat frequencies similar to the step. Sounds, mainly rhythm, have also been shown to improve gait characteristics (speed, time and cadence of passage) and eliminate frozen gait, characteristic in this type of population. Sound strategies such as Binaural Beats (BBs) improve the ability of upper and lower limb movements in PD patients. Specifically, this technology is characterized by presenting two tones of different frequencies for each ear in order to influence the mood and mental performance of the listener. In accordance with the above, this protocol is proposed in order to evaluate the effect of tDCS combined with auditory and binaural stimulus strategies during gait therapy in patients with Parkinson's disease.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parkinson Disease
  • Both gender
  • Informed consent accepted

排除标准

  • Mental diseases
  • Injuries in the scalp skin
  • Inflammatory tegumentary diseases
  • Migraines
  • Pregnancy

结局指标

主要结局

Gait Deviation Index Baseline

时间窗: Baseline

Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system

Gait Deviation Index Post-Intervention

时间窗: 8 weeks

Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system

次要结局

  • Power spectral density in the frequency of motor imagery from primary motor cortex Post-Intervention(8 weeks)
  • Power spectral density in the frequency of motor imagery from primary motor cortex Baseline(Baseline)

研究者

发起方
Corporación de Rehabilitación Club de Leones Cruz del Sur
申办方类型
Other
责任方
Sponsor

研究点 (2)

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