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

July 20, 2024 updated by: Chongwen Zuo, Air Force Military Medical University, China

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Air Force Medical Center of PLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MI-BCI combined with tDCS
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
before and after 4 weeks
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
before and after 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Air Force Military Medical University, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chongwen Zuo, Doctoral, Air Force Medical Center of Chinese PLA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Air Force Medical Center

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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