Rehabilitative BCI in Acute Ischemic Stroke

January 8, 2021 updated by: Xuanwu Hospital, Beijing

Rehabilitative BCI for Lower Limb Function Recovery in Acute Ischemic Stroke

In order to explore the role and expound the mechanism of rehabilitative brain computer interface (BCI)-based training (referred to as the Walk Again Neurorehabilitation protocol) in neurofunctional reconstruction in acute phase of cerebral infarction, the investigators choose non-invasive BCI to study lower limb function of patients with acute cerebral infarction. The investigators evaluate lower limb function, the influence on the central brain functional network and relevant immuno-inflammatory indicators, so that the investigators can explore the therapeutic effect and mechanism in the acute phase of cerebral infarction and provide theoretical bases and feasible guidances for the treatment of post-stroke dyskinesia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The participants will be randomly divided into experimental group and control group. The experimental group will receive BCI-based lower limb functional training, 30 minutes per time, 5 times per week, with a 4-week training period; the control group will only receive routine lower limb training, with the same treatment frequency, intensity and duration. Statistical analysis will be performed to compare the relevant evaluation indexes of the experimental group and the control group after treatment and 90 days. In this study, the investigators will use Lower Extremity Fugl-Meyer Assessment (LE-FMA) to comprehensively evaluate the function of lower limbs, Functional Ambulation Category Scale (FAC) and 10-meter walking test (10MWT) for walking ability, modified Barthel index (MBI) for daily living abilities, functional magnetic resonance imaging（fMRI）and near infrared functional brain imaging (NIRS) to evaluate brain function and network reconstruction, the translocator protein(TSPO)-positron emission tomography (PET) and blood immune inflammation indicators to evaluate systemic and intracranial immune status.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • 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.

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

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The diagnosis of cerebral infarction conforms to the diagnostic criteria of "Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018".
  2. 35 ≤ age ≤ 60 .
  3. Onset (last-seen-well) time to randomization time from 24-72 hours.
  4. First onset.
  5. The lesion is assessed by MRI as a single subcortical infarction of the anterior circulation.
  6. 5 ≤NIHSS≤15 (and 1 ≤6a/b≤3 ).
  7. 1 ≤FAC functional walking scale score ≤ 3.
  8. Signed informed consent from subject or legally authorized representative.

Exclusion Criteria:

  1. Unstable vital signs.
  2. Progressive stroke.
  3. Patients have received intravenous thrombolysis or endovascular treatment.
  4. Cardiogenic cerebral embolism.
  5. Presence of moderate or higher vascular stenosis or vulnerable plaque based on Imaging assessment.
  6. With other diseases of the nervous system.
  7. With serious diseases of other systems (severe circulatory system, respiratory system, motor system) and other diseases unsuitable for training, such as atrial fibrillation, heart failure, lung infection, severe liver or kidney insufficiency, lower extremity venous thrombosis.
  8. Lower limb dysfunction caused by other reasons, such as fracture, lower limb deformity, etc.
  9. With contraindications in imaging examinations, such as metal implantation, fear of claustrophobia, and severe obesity.
  10. Patient who cannot cooperate with training, such as mental disorders, cognitive dysfunction, Mini-Mental State Examination (MMSE) <21 points, etc.
  11. Other reasons: alcoholism; pregnancy; skull defect; indwelling urinary catheter; vision defects affect training, etc.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rehabilitative BCI training
The experimental group will receive brain computer interface-based lower limb function training (BCI-LLT), 30 minutes/time, 5 times/week, with a 4-week training period.. The training using the lower limb orthosis targeted the patient's ability to walk.
Device: Non-invasive BCI training
In the experimental group, the participants receive non-invasive rehabilitative BCI training. The training using the lower limb orthosis targeted the patient's ability to walk.
Active Comparator: Traditional physical therapy protocol
The control group will only receive traditional physical therapy protocol. The traditional physical therapy protocol of lower limb conducted with the same treatment frequency, intensity and duration of treatment, including muscle strength training, balance training and walking training, etc.
Other: Traditional Physiotherapy protocol
In the control group，the participants receive the traditional physiotherapy protocol, including muscle strength training, balance training and walking training, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fugl-Meyer score of lower limbs from baseline to 4 weeks.
Time Frame: 0-4 weeks.
It consists of 17 individual assessments that are summed to generate a total score. Scores range from 0-34, the higher the better.
0-4 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional ambulation category scale
Time Frame: 4 weeks and 90 days.
This scale indicates the ability to walk independently and serves as the primary outcome measure.Participants will be asked to walk at their normal comfortable pace (handheld assistive device is acceptable if needed).
4 weeks and 90 days.
10-meter walk test
Time Frame: 4 weeks and 90 days.
Gait speed will be measured as the average of 3 times 10-meter walk tests. Participants will be asked to walk at their normal comfortable pace (handheld assistive device is acceptable if needed).
4 weeks and 90 days.
Modified Barthel index
Time Frame: 4 weeks and 90 days.
Scale range: 0-100 (with higher scores indicating a greater ability to complete activities of daily living)
4 weeks and 90 days.
National Institutes of Health Stroke Scale
Time Frame: 4 weeks and 90 days.
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The range of scores is from 0 (normal) to 42, with higher scores indicating greater stroke severity.
4 weeks and 90 days.
Gait analysis ( stride frequency, step length and velocity)
Time Frame: 4 weeks and 90 days.
To evaluate the walking ability
4 weeks and 90 days.
Nodal functional connectivity strength analysis by functional magnetic resonance imaging
Time Frame: 4 weeks and 90 days.
To evaluate the brain function and network
4 weeks and 90 days.
Changes in oxyhaemoglobin in related cortex by Functional near-infrared spectroscopy
Time Frame: 4 weeks and 90 days.
To evaluate the brain cortex function.
4 weeks and 90 days.
The translocator protein(TSPO)-positron emission tomography (PET)
Time Frame: 4 weeks.
Respond to inflammation in the brain
4 weeks.
Fugl-Meyer score of lower limbs
Time Frame: 90 days.
It consists of 17 individual assessments that are summed to generate a total score. Scores range from 0-34, the higher the better.
90 days.

Collaborators and Investigators

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

Sponsor

Xuanwu Hospital, Beijing

Investigators

  • Principal Investigator: Guoguang Zhao, Xuanwu Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

January 16, 2021

Primary Completion (Anticipated)

December 25, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

December 20, 2020

First Submitted That Met QC Criteria

January 8, 2021

First Posted (Actual)

January 11, 2021

Study Record Updates

Last Update Posted (Actual)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LYS[2020]-133

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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