Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Stroke

Korábbi kezelés

• Patient receiving any therapy at study entry that would interfere with VNS (e.g., drugs that interfere with neurotransmitter mechanisms: anticholinergics, adrenergic blockers, etc.).
• Prior injury to vagus nerve.
• Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug.

Más betegség

• Significant cognitive or language impairment that would interfere with study participation or informed consent. This criterion will be defined by NIHSS item 1a-c score \> 2, item 9 score \> 1, item 11 score = 2.
• Medical conditions that could interfere with study participation, for example ear infections or skin wounds.
• History of stroke
• History of cardiac arrhythmia
• History of severe head trauma, brain surgery, deep brain stimulation, or brain injuries of other etiologies.
• Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent subject from meeting protocol timeline.

Egyéb

• Bradycardia (\< 50 bpm) or hypotension (\< 90/60 mmHg)
• Significant pre-existing disability
• Pregnant or planning on becoming pregnant or breastfeeding during the study period.
• Subjects who are currently in another clinical trial or plan to do so during the study period.

• Age \>18 years and \<75 years
• Unilateral supratentorial ischemic stroke that occurred at least 7 days but not more 30 days before enrollment.
• Modified Rankin Scale between 0 and 1 before stroke
• Contralesional UL motor impairment defined by NIHSS item 5 score ≥ 1 to ≤ 3.
• Ability to provide written informed consent.
• Hemodynamically stable patients.
• Patients residing in the metropolitan area of Bucaramanga.