Trials / Completed
CompletedNCT06513988
Application of MI-BCI Combined With tDCS in Early Rehabilitation After Anterior Cruciate Ligament Reconstruction
Application of MI-BCI Combined With tDCS in Early Rehabilitation After Anterior Cruciate Ligament Reconstruction Monitored by Resting-stage fMRI: the First Case Report
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Air Force Military Medical University, China · Academic / Other
- Sex
- All
- Age
- 20 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-05-06
- Primary completion
- 2024-07-15
- Completion
- 2024-07-15
- First posted
- 2024-07-23
- Last updated
- 2024-07-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06513988. Inclusion in this directory is not an endorsement.