Ischemic stroke
Conditions
Interventions
experimental group:Stage I&Stage II:standard-of-care rehabilitation + standard VNS
6 weeks hospital treatment: three times a week routine rehabilitation treatment + standard vagus nerve stimulation
Fa
Control group:Stage I:active control VNS+standard-of-care rehabilitation
6 weeks hospital treatment: three times a week off to stimulate + conventional rehabilitation
Home therapy: 30 min daily routin
Sponsors
Beijing TianTan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) 18 years old =80 years old, male or female; (2) clinically confirmed ischemic stroke with onset time between 6 months and 5 years; (3) subjects with Fugl-Meyer upper extremity assessment (FMA-UE) score between 20 and 50 (including 20 and 50); (4) subjects with right or left arm weakness; (5) The subject's wrist could actively flexion/extension, and the thumb and at least two other fingers could actively abduction/extension; (6) They were informed about the study and voluntarily participated in the study, and understood all the contents described in the informed consent form.
Exclusion criteria
Exclusion criteria: (1) subjects with known history of hemorrhagic stroke; (2) subjects who had undergone bilateral or unilateral vagotomy; (3) medical or mental instability (severe depression or suicidal, cognitive impairment, the diagnosis of mental illness or drug abuse, etc.), make the participants cannot meet the project schedule, cannot fit the surgery, can not be implemented SPC and cooperate with the follow-up of subjects; (4) Subjects with a known history of allergy to the implanted part of the vagus nerve stimulation system and the materials in contact with human body (titanium, epoxy resin, liquid silicone rubber, etc.); (5) if pregnant, lactating or planning to become pregnant during the study period; (6) subjects with persistent dysphagia or respiratory diseases (including dyspnea or asthma); (7) subjects with severe upper limb spasticity (modified Ashworth scale =3); (8) Participants with significant sensory loss [sensory loss was assessed with the use of the upper-extremity sensory component of the Fugl Meyer Physical Performance, which involves light touch (two items) and proprioception (four items) on a scale of 12, with scores < 6 considered significant]; (9)Subjects undergoing ultrasound therapy and diathermy; (10) Subjects who received botulinum toxin injection 4 weeks before or during the treatment; (11) Subjects whose physical conditions were judged by clinicians to be unsuitable for device implantation (such as allergy to anesthetics, infection or foreign body at the planned implantation site, etc.); (12)Subjects who are participating in clinical trials of other drugs or devices and do not meet the primary endpoint; (13)Other participants who were deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of FMA-UE score on the first day after hospital treatment was compared with the baseline period before treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in FMA-UE score from baseline;The response rate of the upper extremity (FMA-UE) score at the 90th day after 6 weeks of hospital treatment;Change from baseline in Wolf Motor Rating Scale score;Change from baseline in the Stroke Impact Scale score;Change from baseline in Motor Activity Record form (MAL) score;Change from baseline in stroke specific Quality of Life scale (SS-QOL) score;Change from baseline in EQ-5D-5L score;Equipment operation performance evaluation; | — |
Countries
China
Contacts
Public ContactMeng Fangang
Beijing TianTan Hospital, Capital Medical University
Outcome results
None listed