NCT04704427

Rehabilitative BCI in Acute Ischemic Stroke

Rehabilitative BCI for Lower Limb Function Recovery in Acute Ischemic Stroke

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 35 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke, Acute

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-16
• Primary completion: 2021-12-25
• Completion: 2021-12-31
• First posted: 2021-01-11
• Last updated: 2021-01-11