Status:
NOT_YET_RECRUITING
Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Stroke
Lead Sponsor:
Fundación Cardiovascular de Colombia
Collaborating Sponsors:
Ministerio de Ciencia Tecnología e Innovación - Minciencias
Conditions:
Motor Impairment
Motor Impairments
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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.
Detailed Description
Stroke is a neurological condition caused by vascular problems such as cerebral infarction and/or intracerebral or subarachnoid hemorrhage(1). In 2019, more than 12 million strokes occurred worldwide,...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 24 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06895005
Start Date
April 1 2025
End Date
December 24 2025
Last Update
March 30 2025
Active Locations (1)
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1
Neurology Center of Excellence - Hospital Internacional de Colombia - Fundación cardiovascular de Colombia
Piedecuesta, Santander Department, Colombia