Clinical trial NCT02239978: Effect of Levodopa on Postural Motor Learning in Parkinson Disease
Official title: Effect of Levodopa on Postural Motor Learning in Parkinson Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Posture Balance
Learning
Dopamine
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Oregon Health and Science University
First posted: 2014-09-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with Parkinson Disease or age-matched healthy adults in the north west United States (Oregon and Washington state).

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Between 18 and 90 years of age.
* Individuals with Parkinson Disease
* Healthy adults age-matched to PD participants
* Participants with PD will be currently taking dopamine replacement (i.e. Levodopa)

Exclusion Criteria:

All subjects exclusion criteria:

* Deep brain stimulation
* Recent (within 6 months) orthopedic injuries influencing standing or balance
* Inability to stand independently

Transcranial magnetic stimulation exclusion criteria (for the subset of individuals taking part in the Transcranial Magnetic Stimulation portion of the study):

* History of epilepsy or currently taking any epileptic medication,
* History of seizures
* Family history of epilepsy or seizures

Primary outcomes:
measure: Change in Movement of Center of Mass (COM) After Postural Perturbation
timeFrame: Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication
measure: Change in Steps After Postural Perturbation
timeFrame: Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication
Secondary outcomes:
measure: Change in First Step Length
timeFrame: Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication
measure: Cortical Excitability
timeFrame: TMS data was collected ON and OFF medication during one visit. This visit occurred within 3 weeks of the initial postural control assessments.
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System, Salt Lake City, UT
state: Utah
Study officials:
affiliation: VA Salt Lake City Health Care System, Salt Lake City, UT
name: Daniel S Peterson, PhD MS BS
role: PRINCIPAL_INVESTIGATOR
References: