Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Stroke

Launched by FUNDACIÓN CARDIOVASCULAR DE COLOMBIA · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called transcutaneous auricular vagus nerve stimulation, which is a non-invasive way to stimulate a nerve in the ear. The goal is to see how this treatment, combined with physical rehabilitation, can improve the ability to use the arm of patients who have had a stroke. The trial is not yet recruiting participants, but it will focus on adults aged 18 to 75 who have experienced a specific type of stroke within the last 7 to 30 days and have some motor impairment in their arm.

To be eligible for the trial, participants must be able to provide written consent and be in stable health. However, people with significant cognitive or language issues, certain medical conditions, or who are pregnant or breastfeeding will not be able to participate. If you join the study, you can expect to receive this new treatment along with standard rehabilitation efforts, all while being closely monitored by the research team. This could be a valuable opportunity for those looking to improve their recovery after a stroke.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.
• • Bradycardia (\< 50 bpm) or hypotension (\< 90/60 mmHg)
• • Significant pre-existing disability
• • History of stroke
• • History of cardiac arrhythmia
• • History of severe head trauma, brain surgery, deep brain stimulation, or brain injuries of other etiologies.
• • Pregnant or planning on becoming pregnant or breastfeeding during the study period.
• • Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent subject from meeting protocol timeline.
• • Subjects who are currently in another clinical trial or plan to do so during the study period.
• • 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.