Neuromodulation for Functional Recovery After Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXuanwu Hospital, Beijing
About this trial
This study used a multicenter, double-blind, randomized controlled design. The trial protocol was jointly designed by the principal investigator and an executive committee composed of experts in functional neurosurgery, cerebrovascular disease, and rehabilitation medicine. The study enrolled patients in the subacute phase (3-6 months) after ischemic stroke with upper limb motor impairment. All patients were implanted with a vagus nerve stimulation (VNS) device and randomly assigned to an active VNS (0.8 mA) group combined with upper limb rehabilitation or a control VNS (0.0 mA) group.
This study used the FMA-UE score, WMFT score, and other measures to assess changes in impairment severity. The primary endpoint was the difference in FMA-UE score between the active VNS group and the control group at the end of 6 weeks of hospital treatment. Secondary endpoints included changes from baseline in FMA-UE score and WMFT score at 90 days, among others. This study evaluates the safety and efficacy of vagus nerve stimulation for improving upper limb motor function in patients in the subacute phase after stroke, ultimately providing clinical evidence for the diagnosis and treatment of this patient population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
History of unilateral supratentorial ischemic stroke and in the subacute phase (3-6 months);
Age between 18-80 years, both male and female;
FMA-UE score of 20-50 (inclusive);
Ability to communicate, understand, and provide appropriate consent; participant can follow two-step commands;
Disqualifiers
History of hemorrhagic stroke;
Persistent dysphagia or choking/coughing while eating or drinking;
Medications that, at study initiation, may significantly interfere with the effects of VNS on neurotransmitter systems;
Prior vagus nerve injury, bilateral or unilateral (e.g., injury during carotid endarterectomy);
Trial design
Design model
Parallel
Treatments tested in this trial
active VNS (0.8 mA)
Other interventionAfter implantation, participants are randomized 1:1 to active VNS (0.8 mA) combined with upper limb rehabilitation or control VNS (0.0 mA). To reduce the risk of participants inferring treatment assignment, participants in both treatment groups receive five stimuli of decreasing intensity at the beginning of each treatment session (starting at 0.8 mA and then decreasing by 0.1 mA at each step), after which treatment is administered according to randomization.
Control VNS (0.0 mA)
Other interventionAfter implantation, participants randomized to Control VNS (0.8 mA) combined with upper limb rehabilitation.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Active VNS groupExperimental treatment 1 intervention
Group B: Control VNS groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
The difference in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) scores between the active VNS group and the control group at the end of 6 weeks of hospital treatment.
The FMA-UE total score ranges from 0 to 66, with higher scores indicating better upper-extremity motor function.
Time frame
At the end of 6 weeks of hospital treatment.Secondary outcomes
1
Clinically meaningful improvement in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) at 90 days (≥6-point improvement in FMA-UE score);
The FMA-UE total score ranges from 0 to 66, with higher scores indicating better upper-extremity motor function.
Time frame
90 days2
Change from baseline in Wolf Motor Function Test (WMFT) score at 90 days
The WMFT Functional Ability Scale ranges from 0 to 75, with higher scores indicating better upper-extremity function.
Time frame
90 days3
Change from baseline in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) at 90 days
The FMA-UE total score ranges from 0 to 66, with higher scores indicating better upper-extremity motor function.
Time frame
90 daysOther outcomes
1
Change from baseline in Stroke Impact Scale (SIS) score at 90 days
The SIS score ranges from 0 to 100, with higher scores indicating better health status and functioning.
Time frame
90 days2
Change from baseline in Stroke-Specific Quality of Life (SS-QOL) score at 90 days
The SS-QOL total score ranges from 49 to 245, with higher scores indicating better quality of life.
Time frame
90 days3
Change from baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) utility index score at 90 days
The EuroQol 5-Dimension 5-Level utility index ranges from -0.391 to 1.000, with higher scores indicating better health-related quality of life.
Time frame
90 days4
Change from baseline in Motor Activity Log (MAL) score at 90 days
Each MAL subscale ranges from 0 to 5, with higher scores indicating better real-world use and movement quality of the affected upper extremity.
Time frame
90 daysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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