PARKINSON DISEASE (Disorder), Parkinson's Disease (PD)
Conditions
Keywords
nVNS, Vagus nerve, VNS, Parkinson's disease, PD, gammaCore
Brief summary
This study is designed to better understand the mechanisms contributing to impaired activation of leg muscles in people with Parkinson's disease (PD) and to test if stimulation of a nerve at the neck can improve muscle activation, walking and balance.
Detailed description
The goals of this project are twofold: (i) to test the hypothesis that persistent inward currents (PICs) in spinal motoneurons of the ankle extensors are reduced in people with Parkinson's disease and that these changes are associated with impaired postural control and (ii) to examine the acute effects of non-invasive vagus nerve stimulation (nVNS) on PICs and postural control. This project will conduct experiments to test the hypothesis that the firing properties of muscles that control the ankle are significantly altered in people with PD compared to matched healthy adults and that these changes in activity are related to the severity of postural control deficits. In addition, this project will examine the acute effects of non-invasive vagal nerve stimulation (nVNS), an intervention that increases activity in the locus coeruleus and raphe nucleus, on the firing properties of ankle muscles and postural control. If successful, this work will be the first to demonstrate that brainstem pathways that control muscle firing properties are altered in people with PD and are associated with postural impairment. The preliminary trial of nVNS will provide evidence that postural muscle activity can be improved with stimulation and improve postural control. These findings will provide critical preliminary data required to move forward with a clinical trial of nVNS in PD.
Interventions
DEVICEVagal nerve stimulation
The gammaCore non-invasive vagus nerve stimulator (nVNS) is a hand-held portable device that is used to apply electrical stimulation to the vagus nerve via two electrodes.
OTHERNo intervention
No nVNS is applied in the baseline experiment. Sham nVNS is applied for experiment two
Sponsors
University of Minnesota
Parkinson's Foundation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Experiment one will use both a within-subject and cross-sectional design and experiment two will be a double-blind crossover design.
Eligibility
Sex/Gender
ALL
Age
21 Years to 76 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of idiopathic Parkinson's disease, * On stable medication for the preceding month and anticipated over the next 3 months, * Able to ambulate without the use of an assistive device for more than 50 meters. Control Cohort: * Age (± 3 years) and sex distribution matched to the PD cohort, * Able to ambulate without the use of an assistive device for more than 50 meters.
Exclusion criteria
* Failure to demonstrate capacity to consent (based on UBACC and/or MacArthur-CR), * History of significant neurological disorder (besides PD in the PD group), * History of stroke, traumatic brain injury, intracranial aneurysm, intracranial hemorrhage, brain tumor or atypical parkinsonian disorder, * Severe orthopedic or other related musculoskeletal pathology that has significant adverse effects on gait, * Women who are pregnant or may be pregnant, * Insufficient comprehension of the English language, * History of substance abuse in past 2 years; Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in delta-F | Within-session VNS: 0-60 minutes. Between VNS sessions: 1 - 4 weeks. | Difference between baseline and post-VNS delta-F measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Braceheight | Within-session VNS: 0 -60 minutes; between VNS sessions: 1-4 weeks | Change in brace height measure between before and after VNS |
| Step length | Within-session VNS: 0-60 minutes; between VNS sessions: 1-4 weeks | Average step length |
| Peak magnitude force on step leg | Within-session VNS: 0-60 minutes; between VNS sessions: 1-4 weeks | peak magnitude of the step leg loading force during gait initiation |
| Postural sway magnitude | Within-session VNS: 0-60 minutes; between VNS sessions: 1-4 weeks | Root mean square (RMS) of the center of pressure smoothness (jerk) in the medial-lateral plane. |
Countries
United States
Contacts
CONTACTPrincipal Investigator
CONTACTKristin Garland
Outcome results
None listed