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NCT05601661
Safety and Feasibility of Paired Vagus Nerve Stimulation With Rehabilitation for Improving Upper Extremity Function in People With Cervical Spinal Cord Injury
Conditions: Cervical Spinal Cord Injury
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 8
Sponsor: The University of Texas Health Science Center, Houston
Location: United States
Summary
The purpose of this study is to determine the safety and feasibility of pairing vagus nerve stimulation (VNS) with rehabilitation and to determine the efficacy of pairing VNS with rehabilitation.
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 SCIdemonstrate 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, injurypresence of ongoing dysphasia or aspiration difficultiesevidence of vagus pre-existing vocal cord paralysis as determined with laryngoscopy procedureparticipants with prior left-sided anterior cervical surgery who exhibit too much of scar tissue at the surgery site which will be determined by neurosurgeonconcomitant clinically significant brain injuryhistory of prior injury to a vagus nervereceiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entryother comorbidities or complications that will hinder or contraindicate surgical proceduremedical or mental instabilitypregnancy or plans to become pregnant during the study period.
Source: ClinicalTrials.gov (NCT05601661). StuddyBuddy aggregates publicly available trial information.