Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2024-06-03
2028-08-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Paired, Sub-Threshold Stim
Sub-threshold stimulation paired with successful task repetitions
Transcutaneous Electrical Stimulation
Electrical pulse trains applied to the skin overlying putative sites of auricular vagal innervation.
Paired, Supra-Threshold Stim
Supra-threshold stimulation paired with successful task repetition
Transcutaneous Electrical Stimulation
Electrical pulse trains applied to the skin overlying putative sites of auricular vagal innervation.
Unpaired, Sub-Threshold Stim
Sub-threshold stimulation after successful task repetition
Transcutaneous Electrical Stimulation
Electrical pulse trains applied to the skin overlying putative sites of auricular vagal innervation.
Unpaired, Supra-Threshold Stim
Supra-threshold stimulation after successful task repetition
Transcutaneous Electrical Stimulation
Electrical pulse trains applied to the skin overlying putative sites of auricular vagal innervation.
Sham
No stimulation
Sham
Electrodes placed on the skin overlying putative sites of auricular vagal innervation but no current administered.
Interventions
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Transcutaneous Electrical Stimulation
Electrical pulse trains applied to the skin overlying putative sites of auricular vagal innervation.
Sham
Electrodes placed on the skin overlying putative sites of auricular vagal innervation but no current administered.
Eligibility Criteria
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Inclusion Criteria
1. 18-75 years of age
PROSPECTIVE SUBJECTS DIAGNOSED WITH STROKE:
2. Diagnosis of a single stroke resulting in hand impairment
3. Diagnosis of stroke at least six months prior to the time of participation
Exclusion Criteria
1. History of vestibular disorders or dizziness
2. Difficulty maintaining alertness and/or remaining still
3. Pregnant or expecting to become pregnant
4. Diagnosis of neurological and/or musculoskeletal disorder(s) (other than stroke) that affect movement
5. Ocular disease and/or impairment in more than one eye
6. History of seizure and/or epilepsy
7. Implants, devices, or foreign objects in the brain/body that are incompatible with MRI
8. Body size that is incompatible with MRI scanner dimensions
9. Anyone already enrolled and actively participating in another greater than minimal risk study.
PROSPECTIVE SUBJECTS DIAGNOSED WITH STROKE:
10. Other impairments secondary to stroke (e.g., attention, cognition, etc.) that would interfere with the ability to understand study goals or follow simple instructions, as judged by the investigators.
18 Years
75 Years
ALL
Yes
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Michael A. Urbin, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Locations
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VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Dawson J, Liu CY, Francisco GE, Cramer SC, Wolf SL, Dixit A, Alexander J, Ali R, Brown BL, Feng W, DeMark L, Hochberg LR, Kautz SA, Majid A, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Turner DL, Engineer ND, Kimberley TJ. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021 Apr 24;397(10284):1545-1553. doi: 10.1016/S0140-6736(21)00475-X.
Follesa P, Biggio F, Gorini G, Caria S, Talani G, Dazzi L, Puligheddu M, Marrosu F, Biggio G. Vagus nerve stimulation increases norepinephrine concentration and the gene expression of BDNF and bFGF in the rat brain. Brain Res. 2007 Nov 7;1179:28-34. doi: 10.1016/j.brainres.2007.08.045. Epub 2007 Aug 25.
Roosevelt RW, Smith DC, Clough RW, Jensen RA, Browning RA. Increased extracellular concentrations of norepinephrine in cortex and hippocampus following vagus nerve stimulation in the rat. Brain Res. 2006 Nov 13;1119(1):124-32. doi: 10.1016/j.brainres.2006.08.048. Epub 2006 Sep 7.
Safi S, Ellrich J, Neuhuber W. Myelinated Axons in the Auricular Branch of the Human Vagus Nerve. Anat Rec (Hoboken). 2016 Sep;299(9):1184-91. doi: 10.1002/ar.23391. Epub 2016 Jul 12.
Butt MF, Albusoda A, Farmer AD, Aziz Q. The anatomical basis for transcutaneous auricular vagus nerve stimulation. J Anat. 2020 Apr;236(4):588-611. doi: 10.1111/joa.13122. Epub 2019 Nov 19.
Urbin MA, Lafe CW, Simpson TW, Wittenberg GF, Chandrasekaran B, Weber DJ. Electrical stimulation of the external ear acutely activates noradrenergic mechanisms in humans. Brain Stimul. 2021 Jul-Aug;14(4):990-1001. doi: 10.1016/j.brs.2021.06.002. Epub 2021 Jun 18.
Other Identifiers
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I0X1RX004532
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
N4532-R
Identifier Type: -
Identifier Source: org_study_id
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