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

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Device: MI-BCI combined with tDCS treatment

• Registration Number: NCT06513988
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-05-06
• Status Verified: 2024-07
• Primary Completion: 2024-07-15
• Study Completion: 2024-07-15
• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-20
• Last Update Submitted: 2024-07-20
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MI-BCI combined with tDCS	MI-BCI combined with tDCS treatment	The MI-BCI combined with tDCS treatment was performed five days per week (in the late afternoon)

Primary Outcome Measures

Name	Time	Method
IKDC	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	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

Trial Locations

Locations (1)

Air Force Medical Center of PLA; 🇨🇳 Beijing, Beijing, China