An interventional study of Transcutaneous Electrical Stimulation and Sham in Paresis, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
Vagus nerve stimulation (VNS) is thought to activate neural pathways that release chemicals which promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Work from the PI's laboratory has shown that electrical current applied to the external ear modulates physiological indexes of brain states implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms modulated by auricular stimulation to support possible therapeutic effects in the form of motor learning.
Existing evidence supports the use of VNS to enhance the effects of traditional therapy on impairments due to neurological injury. It is known that the vagus nerve forms contacts with neuromodulatory nuclei in the brainstem that release of chemicals shown to be critically involved in attentional control and memory formation. It is also known that the auricular branch of the vagus nerve innervates portions of the external ear providing a possible means to engage similar neural pathways noninvasively via transcutaneous auricular vagus nerve stimulation (taVNS). Recent work from the PI's laboratory shows that electrical current applied to landmarks on the external ear elicits transient effects on pupil dilation, an established physiological index of brain states that support learning. Given the ability to engage the biomarker, the investigators aim to further investigate physiological mechanisms modulated by taVNS and possible effects on learning.
468 studies on the registry are indexed under Paresis; 117 are open to participants now.
This study's planned enrollment of 110 is above the median of 37 across 420 interventional studies indexed under Paresis.
Browse Paresis studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
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ALL PROSPECTIVE SUBJECTS:
18-75 years of age
PROSPECTIVE SUBJECTS DIAGNOSED WITH STROKE:
Exclusion Criteria:
ALL PROSPECTIVE SUBJECTS:
Anyone already enrolled and actively participating in another greater than minimal risk study.
PROSPECTIVE SUBJECTS DIAGNOSED WITH STROKE:
Sub-threshold stimulation paired with successful task repetitions
Other: Transcutaneous Electrical Stimulation
Supra-threshold stimulation paired with successful task repetition
Other: Transcutaneous Electrical Stimulation
Sub-threshold stimulation after successful task repetition
Other: Transcutaneous Electrical Stimulation
Supra-threshold stimulation after successful task repetition
Other: Transcutaneous Electrical Stimulation
No stimulation
Other: Sham
Electrical pulse trains applied to the skin overlying putative sites of auricular vagal innervation.
Electrodes placed on the skin overlying putative sites of auricular vagal innervation but no current administered.
Force Control Change
Subjects will be tested on the same task used for training that involves controlling finger forces.
Time frame: Pre, 1-week Post, 1-month Post
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Apr 2028, 46 months after the start.
Of 221 non-industry interventional studies with no phase under Paresis, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 55. This study's planned 46 months is above that.
Counting every sponsor, half of 239 studies reached it within 32 months; a quarter within 13 and three quarters within 55.
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