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 @ 12:12 PM
Ignite Modification Date:
2025-12-24 @ 12:12 PM
NCT ID:
NCT05601661
Eligibility Criteria:
Inclusion Criteria:
* a diagnosis of traumatic incomplete (AIS B-D) cervical spinal cord injury (C8 and above)
* at least 12 months post-traumatic SCI
* demonstrate some residual movement in the upper limb (e.g., able to perform pinch movement with thumb and index finger)
* meet all clinical criteria for the surgical VNS implantation as determined by the PI, neurosurgeon, and anesthesiologist.
Exclusion Criteria:
* non-traumatic SCI, injury
* presence of ongoing dysphasia or aspiration difficulties
* evidence of vagus pre-existing vocal cord paralysis as determined with laryngoscopy procedure
* participants with prior left-sided anterior cervical surgery who exhibit too much of scar tissue at the surgery site which will be determined by neurosurgeon
* concomitant clinically significant brain injury
* history of prior injury to a vagus nerve
* receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry
* other comorbidities or complications that will hinder or contraindicate surgical procedure
* medical or mental instability
* pregnancy or plans to become pregnant during the study period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05601661
Study Brief:
Protocol Section:
NCT05601661