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临床试验/NCT06513988
NCT06513988已完成不适用

Application of MI-BCI Combined With tDCS in Early Rehabilitation After Anterior Cruciate Ligament Reconstruction Monitored by Resting-stage fMRI: the First Case Report

Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2024年5月6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
1
试验地点
1
主要终点
IKDC

研究概览

简要总结

To recover lower-limb motor function is a primary goal for rehabilitation after anterior cruciate ligament (ACL) reconstruction. Although quantitative testing and questionnaire evaluation provide a lot of valuable information, while functional magnetic resonance imaging (fMRI) provides a powerful method to assess functional connectivity (FC) involved in motor function recovery before and after receiving a novel combined rehabilitation training. However, our understanding of the FC changes during early rehabilitation after ACL reconstruction is partial and incomplete.

详细描述

ACL has become one of the most common and easily damaged knee ligaments in sports and military training affecting young and active people. The extensive interest in ACL ruptures is related to the subsequent articular degeneration and severe dysfunction, resulting in skeletal muscle functional limitations not only in athletics but also in daily living. Thus, restoring lower limb motor function and stability has become the primary goal after ACL reconstruction (ACLR). Moreover, the newest study has indicated that increased neural activity may reflect central neuroplastic strategies to preserve motor functionality after ACLR[1]. Postsurgical rehabilitation guidelines for the orthopedic clinician recommended a common treatments for ACLR patients[2]; however, because of long time consuming and poor compliance, which are difficult to get patient recognition, it is very urgent to find a safe, effective and easy conduct and alternative therapy. Transcranial direct-current stimulation (tDCS) is a non-invasive technique of brain stimulation that has potential for clinical utility in neurorehabilitation, and could improve the lower excitability, muscle strength and dynamic balance by acting on the primary motor cortex[3]. For another, motor imagery based brain-computer interface (MI-BCI) based neuro rehabilitation paradigms have emerged as a novel iatrotechnics on motor function and brain function recovery[4]. However, it is little explored whether the clinical application of MI-BCI therapy combined with tDCS could be effective for early rehabilitation after ACLR patients. This case report would explore the efficacy and neuromechanism for the ACLR patient treated with MI-BCI training combined with tDCS. BOLD-fMRI was performed before and after four weeks' treatment.

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
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Duration of anterior cruciate ligament injury: 3-12 months
  • Must bet acceptted anterior cruciate ligament reconstruction

排除标准

  • The affected limb has severe ligament and meniscus damage
  • Contralateral lower extremity sports injury
  • Other medical conditions, such as severe disc herniation, are not eligible for the test

结局指标

主要结局

IKDC

时间窗: before and after 4 weeks

The IKDC score is a subjective knee assessment scale used to assess the level of knee function and severity of symptoms. The functional status of the knee joint is assessed by summing the scores for each item, converting the scores to a scale of 0 to 100

resting-stage fMRI

时间窗: before and after 4 weeks

Resting-stage fMRI images data acquisition was carried out in the Air Force Medical Center with a 3.0T MRI scanner (GE Discovery MR750, USA) using the echo planar imaging (BOLD) sequence for 6 min each time (TR/TE = 2000 ms/30 ms, matrix 64 × 64, FOV = 220×220mm2, number of slices = 36) with contiguous 3 mm slice thickness providing whole brain coverage. In addition, a series of anatomical images were also obtained during the first imaging session using T1-weighted 3D TFE sequence with 1×1×1mm resolution

次要结局

未报告次要终点

研究者

发起方
Air Force Military Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chongwen Zuo

Principal Investigator

Air Force Military Medical University, China

研究点 (1)

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