Stroke
Conditions
Keywords
Neuromodulation, Paresis, Neurorehabilitation
Brief summary
The goal of this study is to learn more about the connections between the brain, spinal cord, and muscles and how these connections can be strengthened after neurological injury.
Detailed description
Non-invasive stimulation techniques can be used to appropriately time converging inputs to induce changes in cortical output circuits of human primary motor cortex, a neuromodulatory protocol known as paired-associative stimulation (PAS). Experiments seek to examine interactions between cortical PAS and non-invasive vagus nerve stimulation (VNS) to understand the extent to which VNS amplifies cortical plasticity in humans.
Interventions
OTHERPaired-Associative Stimulation (PAS)
Simultaneous activation of connections in motor cortex via stimulation to the nerves and brain.
Recruits the auricular branch of the vagus nerve which activates brain structures that release chemicals mediating cortical plasticity.
OTHERSham Stimulation
Sub-threshold stimulation that does not activate neural structures.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
INDIVIDUALS WHO HAVE HAD A STROKE: 1. Diagnosis of first ever stroke 2. At least 6 months after stroke onset 3. Motor-evoked potentials in hand/arm muscles 4. Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators. ALL INDIVIDUALS: 5. Between the ages of 18 and 75 years old
Exclusion criteria
INDIVIDUALS WHO HAVE HAD A STROKE: 1. Hemispatial neglect, aphasia, or cognitive impairment that would impact testing and would interfere with the ability to follow simple instructions, as judged by the investigators ALL INDIVIDUALS: 2. Neurological disorder(s) influencing movement (besides stroke) 3. History of seizure or epilepsy 4. Metallic brain implants 5. Bodily implants such as cardioverter defibrillators, insulin pumps, ventriculoperitoneal shunts, cochlear implants, or pacemakers 6. Pregnant or expecting to become pregnant 7. Difficulty maintaining alertness and/or remaining still 8. Silicone or plastic allergy 9. History of vestibular disorders (eg, Vertigo, Meniere's Disease, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in size of evoked potential | 1 week | The primary endpoint is the change from baseline (ie, before PAS) in the size of evoked potentials. Differences in the change between conditions (ie, PAS+VNS vs PAS+Sham) will address whether VNS drives cortical plasticity. |
Countries
United States
Outcome results
None listed