Overview

This trial is active, not recruiting.

Condition parkinson disease
Treatment postural perturbation
Sponsor VA Office of Research and Development
Collaborator Oregon Health and Science University
Start date August 2014
End date January 2016
Trial size 24 participants
Trial identifier NCT02239978, N1480-M

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Arm
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.
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.

Primary Outcomes

Measure
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
Change in steps after postural perturbation
time frame: Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication

Secondary Outcomes

Measure
Change in first step length
time frame: Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication
Cortical Excitability
time frame: TMS will be collected ON and OFF medication during one visit

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title Effect of Levodopa on Postural Motor Learning in Parkinson Disease
Principal investigator Daniel Soren Peterson, PhD MS BS
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.