Limb paralysis after stroke
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Stroke greater than or equal to 6 months; (2) Age = 18 years old and = 70 years old; (3) During the test period, the motor function was significantly improved, and the subjects and their families had a strong desire to permanently implant the stimulator; (4) The subject has a certain ability to understand and express, voluntarily participates and signs the informed consent form
Exclusion criteria
Exclusion criteria: (1) the presence of persistent dyspnea; (2) the presence of language or cognitive impairment; (3) severe depression (Beck Depression Rating Scale= 16 points); (4) Current progressive brain disease; (5) Presence of contraindications to surgical procedures (e.g., history of adverse reactions to anesthetics, considered unsuitable for surgery by the surgeon, etc.); (6) Other stimulation devices such as pacemakers or other nerve stimulators are being used in the body, or other experimental devices or drugs are being used; (7) There is a requirement for hyperthermia treatment at present or during the trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in Fugl-Meyer Assessment at 90 days after surgery compared with baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in Fugl-Meyer Assessment at 180 days after surgery compared with baseline;The change in Modified Ashworth Scale at 90 and 180 days after surgery compared with baseline;The change in sensory evoked potentials in upper and lower limbs aompared with bast 90 and 180 days after surgery celine;The change in motor evoked potentials in upper and lower limbs at 90 and 180 days after surgery compared with baseline;The change in MEG at 90 and 180 days after surgery compared with baseline;The change in EEG at 90 and 180 days after surgery compared with baseline; | — |
Countries
China
Contacts
Changzhou No.2 People’s Hospital