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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COMPLETED
NA
21 participants
INTERVENTIONAL
2024-11-14
2025-10-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
DOUBLE
Study Groups
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Unilateral Left tVNS
Electrical stimulation to the vagus nerve area of the outer ear on the left side.
Unilateral Left tVNS stimulation
Electrical stimulation to the cymba concha or tragus (depending on the ear dimension) of the outer ear on the left side after successful trials.
Bilateral tVNS
Electrical stimulation to the vagus nerve area of the outer ear on both sides.
Bilateral tVNS stimulation
Electrical stimulation to the cymba concha or tragus (depending on the ear dimension) of the outer ear on both sides after successful trials.
Unilateral Left Sham
Electrical stimulation to the non-vagus nerve area of the outer ear on the left side.
Unilateral Left Sham stimulation
Electrical stimulation to the earlobe of the outer ear on the left side after successful trials.
Bilateral Sham
Electrical stimulation to the non-vagus nerve area of the outer ear on both sides.
Bilateral Sham stimulation
Electrical stimulation to the earlobe of the outer ear on both sides after successful trials.
Unilateral Right tVNS
Electrical stimulation to the vagus nerve area of the outer ear on the right side.
Unilateral Right tVNS stimulation
Electrical stimulation to the cymba concha or tragus (depending on the ear dimension) of the outer ear on the right side after successful trials.
Unilateral Right Sham
Electrical stimulation to the non-vagus nerve area of the outer ear on the right side.
Unilateral Right Sham stimulation
Electrical stimulation to the earlobe of the outer ear on the right side after successful trials.
Interventions
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Unilateral Left tVNS stimulation
Electrical stimulation to the cymba concha or tragus (depending on the ear dimension) of the outer ear on the left side after successful trials.
Bilateral tVNS stimulation
Electrical stimulation to the cymba concha or tragus (depending on the ear dimension) of the outer ear on both sides after successful trials.
Unilateral Left Sham stimulation
Electrical stimulation to the earlobe of the outer ear on the left side after successful trials.
Bilateral Sham stimulation
Electrical stimulation to the earlobe of the outer ear on both sides after successful trials.
Unilateral Right tVNS stimulation
Electrical stimulation to the cymba concha or tragus (depending on the ear dimension) of the outer ear on the right side after successful trials.
Unilateral Right Sham stimulation
Electrical stimulation to the earlobe of the outer ear on the right side after successful trials.
Eligibility Criteria
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Inclusion Criteria
* Post-stroke subjects will have persistent hemiparesis on the upper extremity (UE) with some residual UE voluntary movement.
Exclusion Criteria
* Younger than 18 years old or older than 89 years old
* Current or history of cardiac disease
* Have a vision problem not corrected by glasses or contact lenses
* Have an implanted device such as a neurostimulator or cochlear implant
* Current or history of tympanic membrane perforation
* Had a stroke or lesion (including tumor) in your brain
* Had a head injury or brain surgery
* Suffer from frequent or severe headaches
* Had a fainting spell or syncope
* Have any metal in the head such as shrapnel, surgical clips, or fragments from welding or metal work
* Have any implanted device such as cardiac pacemakers, medical pumps, or intra-cardiac lines
* Had any brain-related conditions (i.e. multiple sclerosis, Parkinson, Alzheimer)
* Had any illness that caused brain injury (i.e. meningitis, aneurysm, brain tumor)
* Had any head trauma that was associated with a loss of consciousness or diagnosed as a concussion
* Being treated for any psychiatric condition (i.e. depression, anxiety, PTSD, schizophrenia)
* Suspected of pregnancy
Post-stroke subjects:
* Younger than 18 years old or older than 89 years old
* Current or history of cardiac disease
* Have a vision problem not corrected by glasses or contact lenses
* Have any implanted devices such as a neurostimulator or cochlear implant
* Current or history of tympanic membrane perforation
* No persistent hemiparesis on the upper extremity (UE)
* No residual UE voluntary movement
* A first stroke less than 4 months prior to the participation
* Serious uncontrolled medical conditions
* Excessive pain in any joint of the more affected extremity
* Unable to stand independently for 2 min., transfer independently to and from the toilet or perform sit-to-stand
* Suffer from frequent or severe headaches
* Had a fainting spell or syncope
* Have any metal in the head such as shrapnel, surgical clips, or fragments from welding or metal work
* Have any implanted device such as cardiac pacemakers, medical pumps, or intra-cardiac lines
* Had any illness that caused brain injury (i.e. meningitis, aneurysm, brain tumor)
* Had any head trauma that was associated with a loss of consciousness or diagnosed as a concussion
* Being treated for any psychiatric condition (i.e. depression, anxiety, PTSD, schizophrenia)
* Suspected of pregnancy
* A score of less than 24 on the Folstein Mini-Mental State Examination
* Excessive frailty or lack of stamina (e.g., cannot attend to instructions, stay awake, engage in functional activities, etc.)
* Excessive pain in any joint of the more affected extremity that could limit ability to cooperate with the intervention
18 Years
89 Years
ALL
Yes
Sponsors
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Emory University
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Georgia Institute of Technology
OTHER
Responsible Party
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Principal Investigators
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Minoru Shinohara, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Georgia Institute of Technology
Locations
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Human Neuromuscular Physiology Lab
Atlanta, Georgia, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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H24109
Identifier Type: -
Identifier Source: org_study_id
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