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| ID | Type | Description | Link |
|---|---|---|---|
| I0X1RX004532 | Other Grant/Funding Number | U.S. Department of Veterans Affairs |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paired, Sub-Threshold Stim | Experimental | Sub-threshold stimulation paired with successful task repetitions |
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| Paired, Supra-Threshold Stim | Experimental | Supra-threshold stimulation paired with successful task repetition |
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| Unpaired, Sub-Threshold Stim | Experimental | Sub-threshold stimulation after successful task repetition |
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| Unpaired, Supra-Threshold Stim | Experimental | Supra-threshold stimulation after successful task repetition |
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| Sham | Sham Comparator | No stimulation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Electrical Stimulation | Other | Electrical pulse trains applied to the skin overlying putative sites of auricular vagal innervation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Force Control Change | Subjects will be tested on the same task used for training that involves controlling finger forces. | Pre, 1-week Post, 1-month Post |
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Inclusion Criteria:
ALL PROSPECTIVE SUBJECTS:
18-75 years of age
PROSPECTIVE SUBJECTS DIAGNOSED WITH STROKE:
Diagnosis of a single stroke resulting in hand impairment
Diagnosis of stroke at least six months prior to the time of participation
Exclusion Criteria:
ALL PROSPECTIVE SUBJECTS:
History of vestibular disorders or dizziness
Difficulty maintaining alertness and/or remaining still
Pregnant or expecting to become pregnant
Diagnosis of neurological and/or musculoskeletal disorder(s) (other than stroke) that affect movement
Ocular disease and/or impairment in more than one eye
History of seizure and/or epilepsy
Implants, devices, or foreign objects in the brain/body that are incompatible with MRI
Body size that is incompatible with MRI scanner dimensions
Anyone already enrolled and actively participating in another greater than minimal risk study.
PROSPECTIVE SUBJECTS DIAGNOSED WITH STROKE:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael A Urbin, PhD | Contact | (412) 688-6000 | Michael.Urbin@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Michael A. Urbin, PhD | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Recruiting | Pittsburgh | Pennsylvania | 15240 | United States |
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| ID | Term |
|---|---|
| D010291 | Paresis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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Subjects will be randomized into one of 5 groups and receive the designated stimulation/sham during a training protocol designed to facilitate motor learning.
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| Sham | Other | Electrodes placed on the skin overlying putative sites of auricular vagal innervation but no current administered. |
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| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |