Effect of Levodopa on Postural Motor Learning in Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

Effect of Levodopa on Postural Motor Learning in Parkinson Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02239978
• Other study ID #: N1480-M
• Status: Active, not recruiting
• Phase: N/A
• First received: September 2, 2014
• Last updated: July 19, 2016
• Start date: August 2014
• Est. completion date: September 2016

Study information

• Verified date: July 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: September 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon
United States	VA Salt Lake City Health Care System, Salt Lake City, UT	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication	No
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).	Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication	No
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).	Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication	No
Secondary	Cortical Excitability	Investigators will assess the cortical excitability of the primary motor cortex in a subset of participants. This will be assessed via single pulse Transcranial Magnetic Stimulation, and these data will be correlated to stepping adaptation rates	TMS will be collected ON and OFF medication during one visit	No