A Randomized Single-blind Study of LI-TMS and AVS for Stroke Recovery in Healthy Participants with the Evaluation of the Effect on the Subject Using EEG and the Following Testing.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Work Efficiency (WE)
研究概览
简要总结
This randomized, controlled, single-blind clinical pilot study investigates the therapeutic potential of low-intensity repetitive transcranial magnetic stimulation (LI-TMS) and audio-visual stimulation (AVS) and newly offered interventional protocols in healthy participants for further research on stroke rehabilitation and therapeutic effects.
The goal of this clinical trial is to learn if the intervention can be used in the future treatment of patients recovering after stroke. It will also learn about the safety of low-intensity repetitive transcranial magnetic stimulation and audio-visual stimulation.
The main questions it aims to answer are:
Does intervention with LI-TMS and AVS influence the parameter Work Efficiency (WE) of the participant? Does intervention with LI-TMS and AVS influence the parameter Warming-up work indicator (WU) of the participant? Does intervention with LI-TMS and AVS influence the parameter Psychological Stability (PS) of the participant? Does intervention with LI-TMS and AVS influence the parameter Perceptual Accuracy (Tv) of the participant? Does intervention with LI-TMS and AVS affect changes in the participants electroencephalogram parameters? The researchers will compare the results of LI-TMS and AVS intervention to a control group that received no intervention but only underwent an examination to evaluate the effects of the interventions.
Participants will:
Receive interventions from LI-TMS and AVS every day for 2 weeks with a weekend break on Saturday and Sunday.
Attend the clinic 3 times during the trial and undergo testing and screening. The first clinic visit is before the intervention course. The second clinic visit will be the day immediately following the end of the two-week intervention course. The third visit will be two weeks after the second visit.
详细描述
Stroke is a leading cause of disability worldwide, significantly impacting individuals; quality of life and their ability to perform daily activities. Rehabilitation is critical for stroke survivors as it aims to restore function, improve mobility, and enhance overall well-being.
Auditory-visual stimulation (AVS) is a stroke rehabilitation technique that combines auditory and visual stimuli to promote cognitive and motor recovery. This approach is based on the principles of neuroplasticity, which suggest that engaging multiple senses through receptor systems can promote brain plasticity and recovery after neurological injury such as stroke.
Transcranial Magnetic Stimulation (TMS) is a promising technique in stroke rehabilitation that involves applying magnetic fields to the scalp, which induces electrical currents in specific brain regions. This method is believed to facilitate neuroplasticity, the brains ability to reorganize itself by forming new neural connections.
LI-TMS is a variant of TMS that uses lower intensity magnetic fields. This technique is designed to minimize discomfort while still promoting neuroplasticity. Key aspects of LI-TMS include:
- Safety and Tolerability: LI-TMS is generally well-tolerated, making it suitable for patients who may be sensitive to higher-intensity stimulation.
- Potential for Long-Term Effects: Studies suggest that LI-TMS may lead to sustained improvements in motor function and cognitive abilities, even after treatment has ended.
- Combination with Other Therapies: LI-TMS can be effectively combined with traditional rehabilitation methods, enhancing overall therapeutic outcomes.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be in good general health, as verified by reviewing their medical history and physical examination. They must not have any serious illnesses that could be a barrier to the research.
排除标准
- •somatic and neurological diseases in the exacerbation stage;
- •presence of epileptic seizures on the EEG;
- •cognitive disorders;
- •presence of visual and hearing pathologies that prevent the sessions;
- •women during pregnancy.
结局指标
主要结局
Work Efficiency (WE)
时间窗: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
Work Efficiency (WE) is a key parameter derived from the Schulte table test that quantifies the effectiveness of a participants performance during the test. It reflects the relationship between the number of correct responses and the time taken to complete the task. Calculation of Work Efficiency is calculated using the following formula: WE= T/N. Where: N = the number of tables completed by the participant. T = Time taken to complete the test (measured in seconds). This formula indicates that Work Efficiency increases with either a higher number of correct responses or a shorter completion time. Measurement Units Values in the range of 30 to 50 seconds are good result. Values above 90 seconds are a negative result. Better result of WE suggest better cognitive efficiency and processing speed, while worse result may indicate difficulties in attention or visual processing.
Warming-up Work Indicator (WU)
时间窗: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
Warming-up Work Indicator (WU) indicates the amount of effort or cognitive load that an individual expends during the initial phase of the test. Calculation of WU The WU is typically calculated based on the time taken to complete the first task of the Schulte table test compared to the overall time taken for the entire test. The first tasks time is compared with the average WE time. A WU ratio close to 1 indicates the best possible preparation of the participant, whereas ratios above 1 indicate that more time needs to be taken as a warm-up before optimal performance. WU = T1 / WE Measurement Units A result less than 1.0 is an indicator of good Warming-up Work Indicator; accordingly, the higher 1.0 this indicator is, the more the subject needs preparation for the main job.
Psychological Stability (PS)
时间窗: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
Psychological Stability (PS) is a parameter derived from the Schulte table test that assesses the ability to sustain the operational activity for a long time. It reflects how well a participant can manage distractions and maintain attention throughout the test. Calculation: PS =T(n-1) /WE. Measurement Units. Psychological Stability does not have a standardized unit of measurement; rather, it is often expressed as a score or index that can be compared across individuals or populations. Measurement Units The result indicator less than 1.0 indicates good Psychological Stability, accordingly, the higher this indicator is, the worse the Psychological Stability of the test subject to perform the tasks.
Attention switching time (t)
时间窗: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
The Test of Attention Switching Time Using Black-Red Table is a psychological assessment designed to measure the efficiency of attention switching in individuals. Attention switching time (t) refers to the duration it takes for an individual to shift their focus from one task or stimulus to another. It is a critical parameter in cognitive psychology, as it reflects the efficiency of an individuals cognitive processing and ability to manage attention in dynamic environments. Calculation: The difference between the time required to complete the last task and the sum of the time spent working on the first and the second task will be the time the subject spends switching attention from one activity to another. Measurement Units A shorter completion time of the Attentional Switching Time Test using the Black-Red Tables indicates better attentional switching ability.
Perceptual Accuracy (Tv)
时间窗: Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.
The Memorize and Place Shapes task is a cognitive assessment designed to evaluate spatial memory and perceptual accuracy. Perceptual Accuracy (Tv) refers to the precision with which an individual can recognize and reproduce shapes after they have been memorized. This parameter is crucial in understanding cognitive functions related to memory and visual processing. Calculation: The result is an overall calculation made from the complete number of dots correctly placed on all forms. Among others, the following is calculated: Perceptual accuracy: Tv = (∑ / n) \* 100, where ∑ is the total number of correctly filled-in Remember and dot test forms and n is the number of dot cards viewed. Multiply the result of the division by 100 to obtain the perceptual accuracy in percent. Measurement Units The higher the Perceptual Accuracy (Tv) score on the Memorise and Place Shapes test, the better the participant\'s visual perception.
次要结局
- EEG(Immediately before the intervention course (at baseline), immediately after the intervention course, and 28 days after completion of the intervention course.)
研究者
Viktor Anatolyevich Drobyshev
Doctor of Medical Sciences, Professor of the Department of Hospital Therapy and Medical Rehabilitation at the Novosibirsk State Medical University, Head of the Physiotherapy Department at City Clinical Hospital No. 2
Siberian Scientific Research and Test Center for Biomedical Engineering