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临床试验/NCT06383039
NCT06383039已完成不适用

The Effect of Transcranial Direct Current Stimulation on Balance on Supplementary Motor Area and Cerebellum in Healthy Individuals

Zeynep Soy2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2022年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Demographic Information Form

研究概览

简要总结

Postural control is an adaptive sensorimotor process involving continuous integration of sensory information from three channels. These; visual, somatosensory (proprioceptive) and vestibular senses. The study will be carried out at Istanbul Medipol University. 30 healthy individuals between the ages of 18-25 will be included. To each individual Anodal-supplementary motor area tDCS, Anodal-cerebellar tDCS, Sham tDCS applications will be cross-applied. tDCS application will take 20 minutes and each individual will receive 3 sessions in total. There will be a 72-hour rest period between sessions. Individuals assessed with Demographic Information Form for demographic information, Wii-Fit and Balance Error Scoring System for Static Balance Evaluation, Star Balance Test and Timed Get Up and Go Test for Dynamic Balance Assessment. The aim of this study is to investigate the effect of transcranial direct current stimulation applied on the supplementary motor area and cerebellum on static and dynamic balance in healthy individuals.

详细描述

Postural control is an adaptive sensorimotor process involving continuous integration of sensory information from three channels. These; visual, somatosensory (proprioceptive) and vestibular senses. The cerebellum plays an important role in the planning, initiation and stability of movements, as well as in postural control and balance. The Supplementary Motor Area (SMA) is a section of the cortex that plays a major role in planning both simple and complex motor movements; It has many functions such as sequence of movements (turning one's hand before picking up an object), learning (learning a new balance task), acquiring grammar. The SMA is somatotopic organized and has direct reciprocal connections with the primary motor cortex (M1). Independent of the primary motor cortex (M1), the SMA is thought to play a crucial role in planning motor actions before movement begins. It also contributes to the planning of all body movements together with the basal ganglia and cerebellum during challenging balance tasks.

Modulation of neural regions underlying balance control may be a potential alternative for therapy. Transcranial direct current stimulation (tDCS) is a non-invasive and safe tool that can modulate cerebellar activity. tDCS is an easy, inexpensive and portable device to implement. There are 3 different types of stimulation. While anodal stimulation promotes neural excitability by causing subthreshold depolarization, cathodal stimulation inhibits neural activity, and in addition, anode-cathode application, in which two types of stimulation are used together, provides both facilitation and inhibition according to electrode placement. In a study conducted by Foerster et al. in healthy individuals in 2017, it was found that cerebellar tDCS increased balance stability, and in a study by Ehsani et al. in healthy individuals over 60 years of age in 2017, cerebellar tDCS increased the Berg Balance balance score. In a study conducted by Steiner et al. in 2016 in which cerebellar tDCS was applied to young individuals, it was observed that the trunk deviation angle during balance was decreased in men, while a similar study by Inukai et al. showed a decrease in oscillation after cathodal cerebellar tDCS.

There are studies showing that tDCS applied to the supplementary motor area has positive contributions to balance. It has been shown by Nomura et al. that tDCS applied to the supplementary motor area in healthy individuals causes a significant increase in balance.

There is no study comparing supplementary motor area and cerebellar area application in healthy individuals where tDCS is applied.

In line with these studies, the aim of this study is:

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
Single (Participant)

盲法说明

Participants were not informed which type of current was applied.

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • No neurological, sensory, motor, visual or cognitive impairment,
  • Volunteering to participate in the study,
  • Being between the ages of 18-25,
  • To have formal education at the university.

排除标准

  • Being diagnosed with a psychological disorder.

结局指标

主要结局

Demographic Information Form

时间窗: 4 months

Demographic Information Form includes the patient's personal information, sociodemographic and physical characteristics.İt includes: name, surname, date of the birth, using cigarette / alcohol, presence presence of disease, using drugs

Wii-Fit

时间窗: 4 months

Nintendo Wii Fit Balance Evaluation was carried out in a darkened room with no light. In this setup, the Nintendo Wii Fit image was projected on the wall with a projector. The patient's birth year and height were recorded according to the device's instructions. The patient's weight was calculated in centimeter by the device. The patient was taught how to step on the board. First, the patient was asked to stand looking straight ahead without moving, and the center of gravity on the right and left foot was calculated as a percentage. Then the patient's body mass index was calculated in kg/m\^2. Afterwards, the patient was asked to step in the middle of the balance board with one foot and maintain this position for 30 seconds. A single-leg stabilization test was performed separately for both feet and the results were recorded as a percentage.

Time Up & Go Test

时间窗: 4 months

3 meters area is determined in front of the chair. The patient is asked to get up from his seat and go to the designated place and sit down again. The time is recorded in seconds. shorter time indicates better balance

balance error scoring system

时间窗: 4 months

2 different surfaces and 3 stance positions . Normal floor is used for flat surface, foam block is used for foam surface. Subjects apply the 6 conditions of the test in the following order: flat surface with two legs support, one foot support and tandem stance position; sponge surface with two legs support, one foot support and tandem stance. The duration of each position was measured by a smart watch for approximately 20 seconds. Each mistake made by individuals within 20 seconds was recorded as 1 point. Six different situations counted as errors are as follows: - Pulling the arms over the iliac crest - Opening the eyes - Taking a step, stumbling or falling - Flexing or abducting the hip joint more than 30° - Lifting the foot or heel off the ground - More than five seconds out of the test position staying too long. Error scores were calculated separately for each position and the total error score was obtained by adding the scores. Higher score indicates worse balance

star excursion balance test

时间窗: 4 months

On the determined floor, 4 strips cut in 2 meters length are adhered to form 45 degree angles between them. The participant waits in the middle of the star shape (the point where the lines intersect).The participant reaches as far as she can reach with her foot.Then the other line is passed and a total of 8 lines are completed in this way.At the end of each distance, a mark was made with a pencil so that you could measure it later. Highest score was obtained from 3 reaches in each direction.

次要结局

未报告次要终点

研究者

发起方
Zeynep Soy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zeynep Soy

Principal Investigator

Medipol University

研究点 (2)

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