Skip to main content
OpenTrials
Completed

NCT Number: NCT06513988

Application of MI-BCI Combined With tDCS in Early Rehabilitation After Anterior Cruciate Ligament Reconstruction

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Air Force Medical Center of PLA

Beijing, Beijing Municipality, 100142, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

MI-BCI combined with tDCS treatment

Device

The treatment intervention was carried out in an independent and quite room and included following steps: During the MI-BCI based training, MI of leg flexion and extension training was first performed 10 times to accurate the training threshold, and then later in the formal BCI training, if the attention was reached the threshold, functional electrical stimulator was trigger to stimulate the corresponding muscle to execute the actual action. Additionally, the patient was given a brief training about how to operate tDCS device until he felt comfortable using it, and then asked to show and give feedback to the researcher. For motor function and pain improvement, tDCS is typically delivered with the anode electrode placed over the primary motor cortex (M1), and the cathode over the supraorbital area (SO) to trigger neuroplastic changes[5]. The MI-BCI combined with tDCS treatment was performed five days per week (in the late afternoon), and MI-BCI training for 30min.

Primary outcomes

  1. resting-stage fMRI

    Time frame: 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

  2. IKDC

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.