Table 1.
NC7+iSLT (group A: experimental group) | |||||
Time point | Visit 1 (eligibility screening) |
Visit 2 (baseline) |
Visit 3 (3 days+1 day post-NC7) |
Visit 4 (3 weeks±3 days post-iSLT onset) |
Visit 5 (24 weeks±7 days post-iSLT onset) |
Informed consent | √ | ||||
Inclusion and exclusion criteria scrutiny | √ | ||||
Demographic information | √ | ||||
General physical examination | √ | ||||
Primary outcome | √ | √ | √ | √ | |
Secondary outcomes | √ | √ | √ | √ | |
Safety outcomes | √ | √ | √ | √ | |
Brain plasticity evaluation | √ | √ | √ |
iSLT alone (group B: control group) | |||||
Time point | Visit 1 (eligibility screening) |
Visit 2 (baseline) |
Visit 3 (3 days+1 day, waiting periods onset) |
Visit 4 (3 weeks±3 days post-iSLT onset) |
Visit 5 (24 weeks±7 days post-iSLT onset) |
Informed consent | √ | ||||
Inclusion and exclusion criteria scurtiny | √ | ||||
Demographic information | √ | ||||
General physical examination | √ | ||||
Primary outcome | √ | √ | √ | √ | |
Secondary outcomes | √ | √ | √ | √ | |
Safety assessment | √ | √ | √ | √ | |
Brain plasticity evaluation | √ | √ | √ |
iSLT, intensive speech and language therapy; NC7, C7 neurotomy.;