Safety and Feasibility of Paired Vagus Nerve Stimulation With Rehabilitation for Improving Upper Extremity Function in People With Cervical Spinal Cord Injury
Cervical Spinal Cord Injury
About this trial
This is an interventional treatment trial for Cervical Spinal Cord Injury focused on measuring vagus nerve stimulation
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.
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Treatment group
Control Group
Participants in the treatment group will receive 18 goal-directed upper extremity rehabilitation therapy sessions with paired VNS over six weeks. Followed by 90 days home exercise program.
Participants in the control group will receive 18 goal-directed upper extremity rehabilitation therapy sessions with sham VNS over six weeks. Followed by 90 days home exercise program.