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Completed

NCT Number: NCT02239978

Effect of Levodopa on Postural Motor Learning in Parkinson Disease

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University, Portland, Oregon, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Movement of Center of Mass (COM) After Postural Perturbation

    Time frame: Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication

    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).

  2. Change in Steps After Postural Perturbation

    Time frame: Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication

    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).

Secondary outcomes

  1. Change in First Step Length

    Time frame: Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication

    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).

  2. Cortical Excitability

    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.

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Oregon Health and Science University

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 15, 2014
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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