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

NCT06513988 | Completed

• 1 other identifier: Air Force Medical Center
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Injuries

Keywords

fMRI; MI-BCI; tDCS; after anterior cruciate ligament

Outcome Measures

Primary Outcomes (2)

• 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

  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

  before and after 4 weeks

Study Arms (1)

MI-BCI combined with tDCS

EXPERIMENTAL

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

Device: MI-BCI combined with tDCS treatment

Interventions

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.

MI-BCI combined with tDCS

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Air Force Medical Center of PLA

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Chongwen Zuo, Doctoral

  Air Force Medical Center of Chinese PLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 23, 2024
• Study Start: May 6, 2024
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

CN (1)