Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT06895005
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06895005
Study Brief:
Protocol Section:
NCT06895005