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Tests treatment safety and results for Chronic Incomplete Cervical Spinal Cord Injury (SCI)
Official title Safety and Feasibility of Paired Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) With Upper Limb Rehabilitation in Incomplete Spinal Cord Injury
ClinicalTrials.gov ID: NCT06543277
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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,
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.