Rehabilitative BCI in Acute Ischemic Stroke

Stroke, Acute Clinical Trial

Official title: Rehabilitative BCI for Lower Limb Function Recovery in Acute Ischemic Stroke

Status Not yet recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

• NCT number: NCT04704427
• Study type: Interventional
• Source: Xuanwu Hospital, Beijing
• Contact: Junwei Hao, MD,PHD
• Phone: 010-83199088
• Email: haojunwei@vip.163.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 16, 2021
• Completion date: December 31, 2021