Effect of Levodopa on Postural Motor Learning in Parkinson Disease

NCT02239978 | Completed Results

• 1 other identifier: N1480-M
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 3

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Posture Balance; Learning; Dopamine

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Change in First Step Length

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

• 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.

Study Arms (2)

Parkinsons disease

Individuals with Parkinsons disease

Behavioral: Postural perturbation

Control

Age-matched healthy adults

Behavioral: Postural perturbation

Interventions

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.

Control; Parkinsons disease

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• Deep brain stimulation
• Recent (within 6 months) orthopedic injuries influencing standing or balance
• Inability to stand independently
• History of epilepsy or currently taking any epileptic medication,
• History of seizures
• Family history of epilepsy or seizures

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Oregon Health and Science University: collaborator

Study Sites (3)

Oregon Health & Science University

Portland, Oregon, 97210, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148, United States

Location

Biospecimen

Retention: NONE RETAINED

No Biospecimens will be collected or retained

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Daniel Peterson
• Organization: Salt Lake City VA

daniel.peterson1@asu.edu

6028242279

Study Officials

• Daniel S Peterson, PhD MS BS

  VA Salt Lake City Health Care System, Salt Lake City, UT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 15, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 23, 2017
• Results First Posted: February 23, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)