An interventional study of MI-BCI combined with tDCS treatment in Anterior Cruciate Ligament Injuries, sponsored by Air Force Military Medical University, China. Completed at 1 site in China. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Air Force Military Medical University, China · Not applicable, Interventional, and Treatment
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.
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.
521 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 169 are open to participants now.
This study's enrollment of 1 is below the median of 56 across 378 interventional studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →Air Force Military Medical University, China is the lead sponsor of 178 studies on the registry; 37 are open to participants now.
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The MI-BCI combined with tDCS treatment was performed five days per week (in the late afternoon)
Device: MI-BCI combined with tDCS treatment
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.
resting-stage fMRI
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
Time frame: before and after 4 weeks
IKDC
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
Time frame: before and after 4 weeks
Plan to share: Yes
Supporting information: Clinical study report
No publications or documents are linked to this record.
Ran from May 2024 to primary completion in Jul 2024, 2 months.
Of 241 non-industry interventional studies with no phase under Anterior Cruciate Ligament Injuries, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 70. This study's 2 months is below that.
Counting every sponsor, half of 248 studies reached it within 30 months; a quarter within 14 and three quarters within 70.
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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