Effect of Levodopa on Postural Motor Learning in Parkinson Disease

Completed

• Conditions: Parkinson Disease
• Interventions: Behavioral: Postural perturbation

• Registration Number: NCT02239978
• Lead Sponsor: VA Office of Research and Development

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-15
• Primary Completion: 2016-01
• Study Completion: 2016-09
• Results First Submitted: 2016-10-05
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-04
• Last Update Submitted: 2017-01-04
• Results First Posted: 2017-02-23
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinsons disease	Postural perturbation	Individuals with Parkinsons disease
Control	Postural perturbation	Age-matched healthy adults

Primary Outcome Measures

Name	Time	Method
Change in Steps After Postural Perturbation	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).
Change in Movement of Center of Mass (COM) After Postural Perturbation	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).

Secondary Outcome Measures

Name	Time	Method
Change in First Step Length	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).
Cortical Excitability	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.

Trial Locations

Locations (3)

VA Portland Health Care System, Portland, OR; 🇺🇸 Portland, Oregon, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

VA Salt Lake City Health Care System, Salt Lake City, UT; 🇺🇸 Salt Lake City, Utah, United States