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:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT04534556
Eligibility Criteria:
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Adult, aged 22-79
* Ischemic or hemorrhagic stroke that occurred ≥ 12 months prior to enrollment
* UEFM score of 20 to 50
* Modified Rankin Score of 2, 3, or 4
* Right vocal cord has normal movement when assessed by laryngoscopy
* Women of reproductive potential must use contraceptive protection
* Meets all clinical criteria for the surgical VNS implantation as determined by the PI, surgeon, and anesthesiologist
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
* Deficits in language or attention that interfere with study participation
* Severe spasticity (Modified Ashworth ≥ 3)
* Medical or mental instability that would likely interfere with study protocol
* Receiving any therapy (medication or otherwise) that would interfere with VNS, such as drugs that perturb neurotransmitter action (anticholinergics, adrenergic blockers, etc.)
* Presence of any other implanted electrical stimulation device
* Prior injury to vagus nerve
* Lactating, pregnant, or plan to become pregnant
* Participation in another interventional clinical trial
* Clinical complications that hinder or contraindicate the surgical procedure
* Abusive use of alcohol and/or illegal substances use
* Participants with sickle cell, lupus, clotting disorders or active neoplastic disease.
* Participants with any any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator.
* Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
* Recent history of syncope
* Recent history of dysphagia
* Current or anticipated requirement for diathermy
* Uncontrolled hypertension
* Diagnosed with Cerebral amyloid angiopathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
79 Years
Study:
NCT04534556
Study Brief:
Protocol Section:
NCT04534556