Rehabilitative BCI in Acute Ischemic Stroke

Stroke, Acute Clinical Trial

Official title:

Rehabilitative BCI for Lower Limb Function Recovery in Acute Ischemic Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04704427
• Other study ID #: LYS[2020]-133
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 16, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2020
• Source: Xuanwu Hospital, Beijing
• Contact: Junwei Hao, MD,PHD
• Phone: 010-83199088
• Email: haojunwei[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: December 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

References & Publications (7)

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. Review. Erratum in: Nat Rev Neurol. 2017 Feb 17;13(3):191. — View 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. — View 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. Review. — View 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. Review. — View Citation

López-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. Review. — View Citation

Ramos-Murguialday A, Broetz D, Rea M, Läer 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	4 weeks and 90 days.
Secondary	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).	4 weeks and 90 days.
Secondary	Modified Barthel index	Scale range: 0-100 (with higher scores indicating a greater ability to complete activities of daily living)	4 weeks and 90 days.
Secondary	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.	4 weeks and 90 days.
Secondary	Gait analysis ( stride frequency, step length and velocity)	To evaluate the walking ability	4 weeks and 90 days.
Secondary	Nodal functional connectivity strength analysis by functional magnetic resonance imaging	To evaluate the brain function and network	4 weeks and 90 days.
Secondary	Changes in oxyhaemoglobin in related cortex by Functional near-infrared spectroscopy	To evaluate the brain cortex function.	4 weeks and 90 days.
Secondary	The translocator protein(TSPO)-positron emission tomography (PET)	Respond to inflammation in the brain	4 weeks.
Secondary	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.	90 days.