Table 1. Inclusion and exclusion criteria.

Major inclusion and exclusion criteria
Inclusion
○ 18–85 years of age ○ Symptoms and signs of AIS within the anterior circulation ○ NIHSS ≥ 7 and ≤ 20 ○ Treatment could be initiated within 24 hours post stroke onset ○ Signed informed consent by the patient or legally authorized representative
Exclusion
○ Imaging diagnosis including tumor, abscess, primary intracranial hemorrhage (ICH) or secondary hemorrhage (PH1,PH2) (H1 and H2 were allowed); or symptoms suspicious for sub-arachnoid hemorrhage ○ Culprit lacunar infarct (unless brain imaging demonstrated a relevant lesion > 1.5 cm in size) ○ A stroke in the posterior circulation ○ Minor stroke or rapidly improving neurological symptoms with a high probability of a Transient Ischemic Attack (TIA) ○ Eligibility or treated with IV or IA rtPA or mechanical thrombectomy ○ NIHSS level of consciousness score ≥ 2 ○ Stroke in previous 6 months ○ modified Rankin Score > 2 before the stroke ○ Patients undertaking oral anticoagulants or having received heparin within 48 hours, and /or with elevated aPTT or INR ○ Septic embolus ○ Severe cardiac disease ○ Uncontrolled hypertension (systolic >185 mmHg and/or diastolic >110 mmHg) ○ Serious systemic infection ○ Pregnancy ○ Patients with other implanted neural stimulator ○ Orthodontics or non-Hygienic condition/ problems that prevent procedures within the mouth ○ Life expectancy < 1 year from other causes