Tests ear nerve stimulation with rehabilitation for arm recovery after stroke
Tests ear vagus nerve stimulation with therapy in adults recovering from stroke.
Plain-language title generated from the registry record
Registry title: Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Stroke
Key facts
- Where
- Piedecuesta, ColombiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06895005, who can take part
Where in Colombia
- Neurology Center of Excellence - Hospital Internacional de Colombia - Fundación cardiovascular de ColombiaPiedecuesta, ColombiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundación Cardiovascular de Colombia
- Trial code
- NCT06895005
- Record updated
- 30 March 2025
- Original description
This study will evaluate the effects of transcutaneous vagus nerve stimulation in combination with physical rehabilitation on upper limb motor function of patients with stroke.Read full original descriptionShow less
Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation on Upper Limb Motor Recovery After Stroke
This study will evaluate the effects of transcutaneous vagus nerve stimulation in combination with physical rehabilitation on upper limb motor function of patients with stroke.
Inclusion: 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: 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; 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; 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.