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Effect of Levodopa on Postural Motor Learning in Parkinson Disease

Effect of Levodopa on Postural Motor Learning in Parkinson Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02239978
Enrollment
42
Registered
2014-09-15
Start date
2014-08-31
Completion date
2016-09-30
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Parkinson Disease, Posture Balance, Learning, Dopamine

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.

Interventions

BEHAVIORALPostural 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.

Sponsors

Oregon Health and Science University
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Movement of Center of Mass (COM) After Postural PerturbationBaseline and follow up (24 hours later) both ON and OFF antiparkinson medicationInvestigators 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).
Change in Steps After Postural PerturbationBaseline and follow up (24 hours later) both ON and OFF antiparkinson medicationInvestigators 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

MeasureTime frameDescription
Change in First Step LengthBaseline and follow up (24 hours later) both ON and OFF antiparkinson medicationInvestigators 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 ExcitabilityTMS 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.

Countries

United States

Participant flow

Recruitment details

A total of 42 individuals were enrolled in the study (30 people with Parkinson's disease and 12 healthy older adults)

Participants by arm

ArmCount
Parkinsons Disease
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.
30
Control
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.
12
Total42

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject20

Baseline characteristics

CharacteristicControlParkinsons DiseaseTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
9 Participants19 Participants28 Participants
Age, Categorical
Between 18 and 65 years
3 Participants11 Participants14 Participants
Age, Continuous68.04 years
STANDARD_DEVIATION 6.62
66.05 years
STANDARD_DEVIATION 9.67
67.16 years
STANDARD_DEVIATION 7.1
Gender
Female
6 Participants10 Participants16 Participants
Gender
Male
6 Participants20 Participants26 Participants
Region of Enrollment
United States
12 participants30 participants42 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 300 / 12
serious
Total, serious adverse events
0 / 300 / 12

Outcome results

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).

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

Population: We were unable to collect reliable data on some of the people with PD while OFF medication, which is why there is a discrepancy between the Parkinson's disease and Parkinson's disease Off Medication arms.

ArmMeasureGroupValue (MEAN)Dispersion
Parkinsons DiseaseChange in Movement of Center of Mass (COM) After Postural PerturbationStart Train0.31 metersStandard Deviation 0.11
Parkinsons DiseaseChange in Movement of Center of Mass (COM) After Postural PerturbationEnd Train0.26 metersStandard Deviation 0.1
ControlChange in Movement of Center of Mass (COM) After Postural PerturbationStart Train0.28 metersStandard Deviation 0.05
ControlChange in Movement of Center of Mass (COM) After Postural PerturbationEnd Train0.23 metersStandard Deviation 0.03
Parkinson's Disease Off MedicationChange in Movement of Center of Mass (COM) After Postural PerturbationStart Train0.32 metersStandard Deviation 0.13
Parkinson's Disease Off MedicationChange in Movement of Center of Mass (COM) After Postural PerturbationEnd Train0.31 metersStandard Deviation 0.12
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).

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

Population: We were unable to collect reliable data on some of the people with PD while OFF medication, which is why there is a discrepancy between the Parkinson's disease and Parkinson's disease Off Medication arms.

ArmMeasureGroupValue (MEAN)Dispersion
Parkinsons DiseaseChange in Steps After Postural PerturbationStart Train2.22 Number of stepsStandard Deviation 0.9
Parkinsons DiseaseChange in Steps After Postural PerturbationEnd Train1.92 Number of stepsStandard Deviation 1.15
ControlChange in Steps After Postural PerturbationStart Train2.03 Number of stepsStandard Deviation 0.63
ControlChange in Steps After Postural PerturbationEnd Train1.15 Number of stepsStandard Deviation 0.28
Parkinson's Disease Off MedicationChange in Steps After Postural PerturbationStart Train2.09 Number of stepsStandard Deviation 0.77
Parkinson's Disease Off MedicationChange in Steps After Postural PerturbationEnd Train2.05 Number of stepsStandard Deviation 1.12
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).

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

ArmMeasureGroupValue (MEAN)Dispersion
Parkinsons DiseaseChange in First Step LengthStart of Training0.18 metersStandard Deviation 0.06
Parkinsons DiseaseChange in First Step LengthEnd of Training0.20 metersStandard Deviation 0.08
ControlChange in First Step LengthStart of Training0.25 metersStandard Deviation 0.11
ControlChange in First Step LengthEnd of Training0.27 metersStandard Deviation 0.08
Parkinson's Disease Off MedicationChange in First Step LengthStart of Training0.21 metersStandard Deviation 0.08
Parkinson's Disease Off MedicationChange in First Step LengthEnd of Training0.21 metersStandard Deviation 0.08
Secondary

Cortical Excitability

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.

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.

Population: As noted in our protocol, TMS was assessed in a subgroup of participants with PD. Seven of the 28 PD participants and 0 of the control group (healthy adults) were assessed. PD participants were assessed ON and OFF levodopa. We chose this approach because 1) this aim was exploratory in nature, and 2) MEPs of healthy adults are well characterized.

ArmMeasureValue (MEAN)Dispersion
Parkinsons DiseaseCortical Excitability40.57 % max stim outputStandard Deviation 8.73
ControlCortical Excitability40.71 % max stim outputStandard Deviation 9.97

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026