Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinsons disease | Individuals with Parkinsons disease |
| |
| Control | Age-matched healthy adults |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postural perturbation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication |
Not provided
Inclusion Criteria:
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):
Not provided
Not provided
Individuals with Parkinson Disease or age-matched healthy adults in the north west United States (Oregon and Washington state).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel S Peterson, PhD MS BS | VA Salt Lake City Health Care System, Salt Lake City, UT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97210 | United States | ||
| VA Portland Health Care System, Portland, OR |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 42 individuals were enrolled in the study (30 people with Parkinson's disease and 12 healthy older adults)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Parkinsons Disease | Individuals with Parkinsons disease 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. |
| FG001 | Control | Age-matched healthy adults 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Parkinsons Disease | Individuals with Parkinsons disease 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | We were unable to collect reliable data on some of the people with PD while OFF medication, which is why there is a discrepancy between the "Parkinson's disease" and "Parkinson's disease Off Medication" arms. | Posted | Mean | Standard Deviation | meters | Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parkinsons Disease | Individuals with Parkinsons disease 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Peterson | Salt Lake City VA | 6028242279 | daniel.peterson1@asu.edu |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
No Biospecimens will be collected or retained
|
| 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. | TMS data was collected ON and OFF medication during one visit. This visit occurred within 3 weeks of the initial postural control assessments. |
| Portland |
| Oregon |
| 97239 |
| United States |
| VA Salt Lake City Health Care System, Salt Lake City, UT | Salt Lake City | Utah | 84148 | United States |
| Control |
Age-matched healthy adults 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | Age-matched healthy adults 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. |
| OG002 | Parkinson's Disease Off Medication | These are the same individuals in the "Parkinson's disease" group, but Off their levodopa |
|
|
| Primary | 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). | We were unable to collect reliable data on some of the people with PD while OFF medication, which is why there is a discrepancy between the "Parkinson's disease" and "Parkinson's disease Off Medication" arms. | Posted | Mean | Standard Deviation | Number of steps | Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | meters | Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication |
|
|
|
| Secondary | 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. | As noted in our protocol, TMS was assessed in a subgroup of participants with PD. Seven of the 28 PD participants and 0 of the "control" group (healthy adults) were assessed. PD participants were assessed ON and OFF levodopa. We chose this approach because 1) this aim was exploratory in nature, and 2) MEPs of healthy adults are well characterized. | Posted | Mean | Standard Deviation | % max stim output | TMS data was collected ON and OFF medication during one visit. This visit occurred within 3 weeks of the initial postural control assessments. |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Control | Age-matched healthy adults 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. | 0 | 12 | 0 | 12 |
Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
|
|