An observational study in Parkinson Disease, sponsored by VA Office of Research and Development. Completed at 3 sites in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by VA Office of Research and Development · Observational
The primary goal of this project is to gain a better understanding of whether and how levodopa (a common anti-Parkinson disease medication) alters postural motor learning in people with Parkinson disease. A secondary goal is to assess whether motor cortical excitability, measured via Transcranial magnetic stimulation, is related to postural motor learning.
Participants with Parkinson disease will complete between 50 and 100 postural perturbations (via support surface translations), ON and OFF their dopamine replacement therapy (i.e. levodopa). Adaptation of responses to these perturbations will be tracked. Participants will also undergo transcranial magnetic stimulation to capture cortical excitability of the brain (in particular the motor cortex). Cortical excitability will be correlated to adaptation of stepping (i.e. postural motor learning) ON and OFF levodopa. Investigators will also capture postural motor learning and cortical excitability in age-matched healthy adults.
Investigators hypothesize that dopamine will have a negative effect on postural motor learning, and the cortical excitability will be correlated to postural motor learning.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 42 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
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Individuals with Parkinson Disease or age-matched healthy adults in the north west United States (Oregon and Washington state).
Exclusion Criteria:
All subjects exclusion criteria:
Transcranial magnetic stimulation exclusion criteria (for the subset of individuals taking part in the Transcranial Magnetic Stimulation portion of the study):
Individuals with Parkinsons disease
Behavioral: Postural perturbation
Age-matched healthy adults
Behavioral: Postural perturbation
Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance.
Change in Movement of Center of Mass (COM) After Postural Perturbation
Investigators will assess (via automated and custom Matlab software) the magnitude of COM movement after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).
Time frame: Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication
Change in Steps After Postural Perturbation
Investigators will assess (via automated and custom Matlab software) the number of steps taken after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).
Time frame: Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication
Change in First Step Length
Investigators will assess (via automated and custom Matlab software) the length of the first step after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).
Time frame: Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication
Cortical Excitability
Investigators will assess the cortical excitability of the primary motor cortex in a subset of participants both ON and OFF levodopa. Specifically, we used transcranial magnetic stimulation to stimulate the motor cortex, where we measure muscular activity of the arm (i.e. motor evoked potentials; MEPs). The primary outcome variable noted below is the lowest stimulation setting (measured as a percentage) which results in an MEP in 5 of 10 trials.
Time frame: TMS data was collected ON and OFF medication during one visit. This visit occurred within 3 weeks of the initial postural control assessments.
A total of 42 individuals were enrolled in the study (30 people with Parkinson's disease and 12 healthy older adults)
| Milestone | Parkinsons Disease | Control |
|---|---|---|
| Started | 30 | 12 |
| Completed | 28 | 12 |
| Not completed | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
Investigators will assess (via automated and custom Matlab software) the magnitude of COM movement after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).
| meters | Parkinsons Disease | Control | Parkinson's Disease Off Medication |
|---|---|---|---|
| Start Train | 0.31 ± 0.11 | 0.28 ± 0.05 | 0.32 ± 0.13 |
| End Train | 0.26 ± 0.10 | 0.23 ± 0.03 | 0.31 ± 0.12 |
Investigators will assess (via automated and custom Matlab software) the number of steps taken after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).
| Number of steps | Parkinsons Disease | Control | Parkinson's Disease Off Medication |
|---|---|---|---|
| Start Train | 2.22 ± 0.9 | 2.03 ± 0.63 | 2.09 ± 0.77 |
| End Train | 1.92 ± 1.15 | 1.15 ± 0.28 | 2.05 ± 1.12 |
Investigators will assess (via automated and custom Matlab software) the length of the first step after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).
| meters | Parkinsons Disease | Control | Parkinson's Disease Off Medication |
|---|---|---|---|
| Start of Training | 0.18 ± 0.06 | 0.25 ± 0.11 | 0.21 ± 0.08 |
| End of Training | 0.20 ± 0.08 | 0.27 ± 0.08 | 0.21 ± 0.08 |
Investigators will assess the cortical excitability of the primary motor cortex in a subset of participants both ON and OFF levodopa. Specifically, we used transcranial magnetic stimulation to stimulate the motor cortex, where we measure muscular activity of the arm (i.e. motor evoked potentials; MEPs). The primary outcome variable noted below is the lowest stimulation setting (measured as a percentage) which results in an MEP in 5 of 10 trials.
| % max stim output | Parkinsons Disease | Parkinson's Disease Off Medication |
|---|---|---|
| Cortical Excitability | 40.57 ± 8.73 | 40.71 ± 9.97 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Parkinsons Disease | — | 0/30 (0%) | 0/30 (0%) |
| Control | — | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Parkinsons Disease | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 3 | 14 |
| >=65 years | 19 | 9 | 28 |
| Age, Continuous(years) | Parkinsons Disease | Control | Total |
|---|---|---|---|
| Mean | 66.05 ± 9.67 | 68.04 ± 6.62 | 67.16 ± 7.10 |
| Gender(Participants) | Parkinsons Disease | Control | Total |
|---|---|---|---|
| Female | 10 | 6 | 16 |
| Male | 20 | 6 | 26 |
| Region of Enrollment(participants) | Parkinsons Disease | Control | Total |
|---|---|---|---|
| United States | 30 | 12 | 42 |
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