Rehabilitative BCI in Acute Ischemic Stroke

NCT04704427 | Unknown

• 1 other identifier: LYS[2020]-133
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke, Acute

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  0-4 weeks.

Secondary Outcomes (9)

• Functional ambulation category scale

  4 weeks and 90 days.

• 10-meter walk test

  4 weeks and 90 days.

• Modified Barthel index

  4 weeks and 90 days.

• National Institutes of Health Stroke Scale

  4 weeks and 90 days.

• Gait analysis ( stride frequency, step length and velocity)

  4 weeks and 90 days.

Study Arms (2)

Rehabilitative BCI training

EXPERIMENTAL

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

Traditional physical therapy protocol

ACTIVE COMPARATOR

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

Interventions

Non-invasive BCI training DEVICE

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.

Rehabilitative BCI training

Traditional Physiotherapy protocol OTHER

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

Traditional physical therapy protocol

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The diagnosis of cerebral infarction conforms to the diagnostic criteria of "Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018".
• ≤ 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.
• ≤NIHSS≤15 (and 1 ≤6a/b≤3 ).
• ≤FAC functional walking scale score ≤ 3.
• Signed informed consent from subject or legally authorized representative.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Related Publications (7)

• 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.

  PMID: 23147846 BACKGROUND

• 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.

  PMID: 23494615 BACKGROUND

• 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.

  PMID: 30056435 BACKGROUND

• 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.

  PMID: 27539560 BACKGROUND

• 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.

  PMID: 28275048 BACKGROUND

• 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.

  PMID: 27513629 BACKGROUND

• 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.

  PMID: 31043637 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Guoguang Zhao

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junwei Hao, MD,PHD

CONTACT

010-83199088; haojunwei@vip.163.com

Haijie Liu, MD,PHD

CONTACT

+8615822841534; haijieliu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: January 11, 2021
• Study Start: January 16, 2021
• Primary Completion: December 25, 2021
• Study Completion: December 31, 2021
• Last Updated: January 11, 2021

Record last verified: 2020-12