Lower Limb Motor Dysfunction after Stroke
Conditions
Interventions
Pure MI-BCI Training Group:1. MI-BCI intervention: The motor intention of the subjects is analyzed and decoded, and then output as a movement command to drive the lower limb pedals of an external devi
Duration: 60 minutes per session, 1 session per day, 5 days per week, for a total of 4 weeks.
3. During MI-BCI training, sham ta-VNS stimulation is applied to the concha of the subjects (i.e., the ta-
MI-BCI Training with Synchronized ta-VNS Group:1. MI-BCI training and conventional treatment intervention (the intervention measures are the same as those in the pure MI-BCI training group).
2. During
Pre-MI-BCI ta-VNS Group:1. MI-BCI training and conventional treatment intervention (the intervention measures are the same as those in the pure MI-BCI training group).
2. Before MI-BCI training, ta-VN
Post-MI-BCI ta-VNS Group:1. MI-BCI training combined with conventional treatment intervention (the intervention measures are the same as those in the pure MI-BCI training group).
2. After MI-BCI trai
Sponsors
The Seventh Affiliated Hospital of Sun Yat-sen University(Shenzhen)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria for stroke (including cerebral hemorrhage and cerebral infarction) established by the Fourth National Cerebrovascular Disease Academic Conference; 2.First episode of illness, and confirmed as cerebral hemorrhage or cerebral infarction by cranial CT or MRI, with a disease duration of >=1 month; 3.Aged between 18 and 80 years old, inclusive of 18 and 80 years old, without limitation of gender; 4.Mini-Mental Status Examination (MMSE) score >=21, able to cooperate in completing the experiment; 5.Seated balance level 1 or above; 6.Stable vital signs; 7.All patients have signed the informed consent for treatment.
Exclusion criteria
Exclusion criteria: 1. Previous bilateral or unilateral vagus nerve damage; 2. Currently using other stimulation devices such as pacemakers or other neurostimulators; 3. Severe mental disorders that prevent understanding of instructions and cooperation; 4. Presence of other musculoskeletal and neurological diseases that affect functional recovery; 5. Presence of malignancies, severe cardiac, hepatic, pulmonary, or renal insufficiency, and severe primary diseases in the endocrine, hematopoietic, or immune systems; 6. Severe lower limb pain or spasms that hinder pedal movement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Assessment of Lower Extremity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Montreal Cognitive Assessment;Berg Balance Scale;Kinesthetic and Visual Imagery Question-naine;MI-BCI Performance;Electroencephalogram;Motor Evoked Potential; | — |
Countries
China
Contacts
Public ContactLin Qiang
The Seventh Affiliated Hospital of Sun Yat-sen University (Shenzhen)
Outcome results
None listed