NCT07841431Not yet recruiting

Neuromodulation for Functional Recovery After Stroke

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Study type: Interventional
Enrollment: 100 (estimated)
First submitted: 13 Sept 2026
Start date: 30 Oct 2026
Primary completion date: 1 Sept 2028
Lead sponsor: Xuanwu Hospital, Beijing
Diseases: Stroke
NCT number: NCT07841431

What you commit to

Study type: Interventional
Planned participants: 100
From 30 Oct 2026 to the primary completion date, 1 Sept 2028
No sites listed in no country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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);
Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug;

Other illness

History of hemorrhagic stroke;
Candidates unsuitable for device implantation surgery (e.g., history of adverse reaction to anesthesia, deemed unsuitable as a surgical candidate by the surgeon, etc.);
Preexisting neurological or psychiatric disorders before stroke onset that affect assessment of the condition;
Other conditions that the investigator considers unsuitable for participation or that may pose a significant risk to the patient.

Other

Persistent dysphagia or choking/coughing while eating or drinking;
Severe or more severe depression (Beck Depression Inventory \>29);
Pregnancy, planned pregnancy, or breastfeeding during the study period;
Severe upper limb spasticity (modified Ashworth ≥3);
Severe sensory loss. Sensory loss will be measured using the upper extremity sensory portion of the Fugl-Meyer Assessment. The assessment involves light touch (two items) and proprioception (four items). The maximum score is 12; subjects with a score below 6 will be excluded from the study;

Who the study is looking for

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;
Right or left upper limb weakness;
Active flexion/extension of the wrist or fingers;
Informed consent signed by the patient or a family member.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.