Stroke, Acute
Conditions
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
To establish a link between the physiological mechanisms driving enhanced motor control in response to VNS, subjects will undergo progressive training on a visuomotor task that requires fine gradation of voluntary motor output to control a moving object through target boundaries. In separate groups, VNS or sham stimulation will be paired with movement when a minimal time-on-target (ToT) is achieved.
Interventions
OTHERTraining
Controlling movement of an object on computer screen by adjusting muscle activity.
OTHERVagus Nerve Stimulation
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
TREATMENT
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 time-on-target score. | 3 weeks | The score reflects the total time the object overlaps any part of targets, expressed as a percentage (0-100) of the total possible time. Thus, a score of 0 is the worst possible score, whereas, 100 is the best possible score. The primary endpoint is the change from baseline (ie, before training) in the time-on-target score. |
Countries
United States
Outcome results
None listed