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Safety and Feasibility of Paired Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) With Upper Limb Rehabilitation in Incomplete Spinal Cord Injury

RecruitingNAAges 18 Years - anyAllThe University of Texas Health Science Center, Hoโ€ฆ
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate the safety and feasibility of transcutaneous auricular Vagus Nerve Stimulation (taVNS) paired with upper-limb rehabilitation in adults with tetraplegia caused by cervical spinal cord injury.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * diagnosis of traumatic incomplete (AIS B-D) cervical spinal cord injury (C8 and above) * at least 12 months post-traumatic SCI but less than 10 years post-SCI * demonstrate some residual movement in the upper limb (e.g., able to perform pinch movement with thumb and index finger sufficient to grip small objects such as marble) Exclusion Criteria: * non-traumatic SCI * recent ear trauma and skin lesions at the site of stimulation, such as sunburn, cuts, and open sores, * facial or ear pain, * allergic reaction to adhesives and electrodes, * any current or past history of cardiovascular disorders, * intracranial metal implants, pacemakers, * concomitant clinically significant brain injury, * receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry * If there is a plan for alteration in upper-extremity therapy or medication for muscle tone during the course of the study; * medical or mental instability; * pregnancy or plans to become pregnant during the study period
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What it tests

  • Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
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Where

2 sites
Neurorecovery Research Center, TIRR MHH
Houston, United States
The University of Texas Health Science Center at Houston
Houston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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