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Rehabilitative BCI in Acute Ischemic Stroke

Primary Purpose

Stroke, Acute

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Non-invasive BCI training

Traditional Physiotherapy protocol

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Brain Computer Interface, Lower Limb Function Recovery, Brain Machine Interface

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Unstable vital signs.
Progressive stroke.
Patients have received intravenous thrombolysis or endovascular treatment.
Cardiogenic cerebral embolism.
Presence of moderate or higher vascular stenosis or vulnerable plaque based on Imaging assessment.
With other diseases of the nervous system.
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.
Lower limb dysfunction caused by other reasons, such as fracture, lower limb deformity, etc.
With contraindications in imaging examinations, such as metal implantation, fear of claustrophobia, and severe obesity.
Patient who cannot cooperate with training, such as mental disorders, cognitive dysfunction, Mini-Mental State Examination (MMSE) <21 points, etc.
Other reasons: alcoholism; pregnancy; skull defect; indwelling urinary catheter; vision defects affect training, etc.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rehabilitative BCI training

Traditional physical therapy protocol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Fugl-Meyer score of lower limbs from baseline to 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.

Secondary Outcome Measures

Functional ambulation category scale

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).

10-meter walk test

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).

Modified Barthel index

Scale range: 0-100 (with higher scores indicating a greater ability to complete activities of daily living)

National Institutes of Health Stroke Scale

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.

Gait analysis ( stride frequency, step length and velocity)

To evaluate the walking ability

Nodal functional connectivity strength analysis by functional magnetic resonance imaging

To evaluate the brain function and network

Changes in oxyhaemoglobin in related cortex by Functional near-infrared spectroscopy

To evaluate the brain cortex function.

The translocator protein(TSPO)-positron emission tomography (PET)

Respond to inflammation in the brain

Fugl-Meyer score of lower limbs

It consists of 17 individual assessments that are summed to generate a total score. Scores range from 0-34, the higher the better.

Full Information

NCT ID

NCT04704427

First Posted

December 20, 2020

Last Updated

January 8, 2021

Sponsor

Xuanwu Hospital, Beijing

1. Study Identification

Unique Protocol Identification Number

NCT04704427

Brief Title

Rehabilitative BCI in Acute Ischemic Stroke

Official Title

Rehabilitative BCI for Lower Limb Function Recovery in Acute Ischemic Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 16, 2021 (Anticipated)

Primary Completion Date

December 25, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xuanwu Hospital, Beijing

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Acute

Keywords

Brain Computer Interface, Lower Limb Function Recovery, Brain Machine Interface

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rehabilitative BCI training

Arm Type

Experimental

Arm Description

Arm Title

Traditional physical therapy protocol

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Non-invasive BCI training

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Traditional Physiotherapy protocol

Intervention Description

In the control group，the participants receive the traditional physiotherapy protocol, including muscle strength training, balance training and walking training, etc.

Primary Outcome Measure Information:

Title

Change in Fugl-Meyer score of lower limbs from baseline to 4 weeks.

Description

It consists of 17 individual assessments that are summed to generate a total score. Scores range from 0-34, the higher the better.

Time Frame

0-4 weeks.

Secondary Outcome Measure Information:

Title

Functional ambulation category scale

Description

Time Frame

4 weeks and 90 days.

Title

10-meter walk test

Description

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).

Time Frame

4 weeks and 90 days.

Title

Modified Barthel index

Description

Scale range: 0-100 (with higher scores indicating a greater ability to complete activities of daily living)

Time Frame

4 weeks and 90 days.

Title

National Institutes of Health Stroke Scale

Description

Time Frame

4 weeks and 90 days.

Title

Gait analysis ( stride frequency, step length and velocity)

Description

To evaluate the walking ability

Time Frame

4 weeks and 90 days.

Title

Nodal functional connectivity strength analysis by functional magnetic resonance imaging

Description

To evaluate the brain function and network

Time Frame

4 weeks and 90 days.

Title

Changes in oxyhaemoglobin in related cortex by Functional near-infrared spectroscopy

Description

To evaluate the brain cortex function.

Time Frame

4 weeks and 90 days.

Title

The translocator protein(TSPO)-positron emission tomography (PET)

Description

Respond to inflammation in the brain

Time Frame

4 weeks.

Title

Fugl-Meyer score of lower limbs

Description

It consists of 17 individual assessments that are summed to generate a total score. Scores range from 0-34, the higher the better.

Time Frame

90 days.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The diagnosis of cerebral infarction conforms to the diagnostic criteria of "Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018". 35 ≤ age ≤ 60 . Onset (last-seen-well) time to randomization time from 24-72 hours. First onset. The lesion is assessed by MRI as a single subcortical infarction of the anterior circulation. 5 ≤NIHSS≤15 (and 1 ≤6a/b≤3 ). 1 ≤FAC functional walking scale score ≤ 3. Signed informed consent from subject or legally authorized representative. Exclusion Criteria: Unstable vital signs. Progressive stroke. Patients have received intravenous thrombolysis or endovascular treatment. Cardiogenic cerebral embolism. Presence of moderate or higher vascular stenosis or vulnerable plaque based on Imaging assessment. With other diseases of the nervous system. 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. Lower limb dysfunction caused by other reasons, such as fracture, lower limb deformity, etc. With contraindications in imaging examinations, such as metal implantation, fear of claustrophobia, and severe obesity. Patient who cannot cooperate with training, such as mental disorders, cognitive dysfunction, Mini-Mental State Examination (MMSE) <21 points, etc. Other reasons: alcoholism; pregnancy; skull defect; indwelling urinary catheter; vision defects affect training, etc.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Junwei Hao, MD,PHD

Phone

010-83199088

haojunwei@vip.163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Haijie Liu, MD,PHD

Phone

+8615822841534

haijieliu@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guoguang Zhao

Organizational Affiliation

Xuanwu Hospital, Beijing

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

23147846

Citation

Jackson A, Zimmermann JB. Neural interfaces for the brain and spinal cord--restoring motor function. Nat Rev Neurol. 2012 Dec;8(12):690-9. doi: 10.1038/nrneurol.2012.219. Epub 2012 Nov 13.

Results Reference

background

PubMed Identifier

23494615

Citation

Ramos-Murguialday A, Broetz D, Rea M, Laer L, Yilmaz O, Brasil FL, Liberati G, Curado MR, Garcia-Cossio E, Vyziotis A, Cho W, Agostini M, Soares E, Soekadar S, Caria A, Cohen LG, Birbaumer N. Brain-machine interface in chronic stroke rehabilitation: a controlled study. Ann Neurol. 2013 Jul;74(1):100-8. doi: 10.1002/ana.23879. Epub 2013 Aug 7.

Results Reference

background

PubMed Identifier

30056435

Citation

Lopez-Larraz E, Sarasola-Sanz A, Irastorza-Landa N, Birbaumer N, Ramos-Murguialday A. Brain-machine interfaces for rehabilitation in stroke: A review. NeuroRehabilitation. 2018;43(1):77-97. doi: 10.3233/NRE-172394.

Results Reference

background

PubMed Identifier

27539560

Citation

Chaudhary U, Birbaumer N, Ramos-Murguialday A. Brain-computer interfaces for communication and rehabilitation. Nat Rev Neurol. 2016 Sep;12(9):513-25. doi: 10.1038/nrneurol.2016.113. Epub 2016 Aug 19. Erratum In: Nat Rev Neurol. 2017 Feb 17;13(3):191.

Results Reference

background

PubMed Identifier

28275048

Citation

Lebedev MA, Nicolelis MA. Brain-Machine Interfaces: From Basic Science to Neuroprostheses and Neurorehabilitation. Physiol Rev. 2017 Apr;97(2):767-837. doi: 10.1152/physrev.00027.2016.

Results Reference

background

PubMed Identifier

27513629

Citation

Donati AR, Shokur S, Morya E, Campos DS, Moioli RC, Gitti CM, Augusto PB, Tripodi S, Pires CG, Pereira GA, Brasil FL, Gallo S, Lin AA, Takigami AK, Aratanha MA, Joshi S, Bleuler H, Cheng G, Rudolph A, Nicolelis MA. Long-Term Training with a Brain-Machine Interface-Based Gait Protocol Induces Partial Neurological Recovery in Paraplegic Patients. Sci Rep. 2016 Aug 11;6:30383. doi: 10.1038/srep30383.

Results Reference

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PubMed Identifier

31043637

Citation

Selfslagh A, Shokur S, Campos DSF, Donati ARC, Almeida S, Yamauti SY, Coelho DB, Bouri M, Nicolelis MAL. Non-invasive, Brain-controlled Functional Electrical Stimulation for Locomotion Rehabilitation in Individuals with Paraplegia. Sci Rep. 2019 May 1;9(1):6782. doi: 10.1038/s41598-019-43041-9. Erratum In: Sci Rep. 2019 Dec 4;9(1):18654.

Results Reference

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Rehabilitative BCI in Acute Ischemic Stroke

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