Trial Outcomes & Findings for Effect of Levodopa on Postural Motor Learning in Parkinson Disease (NCT NCT02239978)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

42 participants

Primary outcome timeframe

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

Results posted on

2017-02-23

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	30	12
Overall Study COMPLETED	28	12
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Effect of Levodopa on Postural Motor Learning in Parkinson Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parkinsons Disease n=30 Participants 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.	Control n=12 Participants 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.	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	9 Participants n=7 Participants	28 Participants n=5 Participants
Age, Continuous	66.05 years STANDARD_DEVIATION 9.67 • n=5 Participants	68.04 years STANDARD_DEVIATION 6.62 • n=7 Participants	67.16 years STANDARD_DEVIATION 7.10 • n=5 Participants
Gender Female	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Gender Male	20 Participants n=5 Participants	6 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	12 participants n=7 Participants	42 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Parkinsons Disease n=28 Participants 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.	Control n=12 Participants 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.	Parkinson's Disease Off Medication n=24 Participants These are the same individuals in the "Parkinson's disease" group, but Off their levodopa
Change in Movement of Center of Mass (COM) After Postural Perturbation Start Train	0.31 meters Standard Deviation 0.11	0.28 meters Standard Deviation 0.05	0.32 meters Standard Deviation 0.13
Change in Movement of Center of Mass (COM) After Postural Perturbation End Train	0.26 meters Standard Deviation 0.10	0.23 meters Standard Deviation 0.03	0.31 meters Standard Deviation 0.12

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Parkinsons Disease n=28 Participants 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.	Control n=12 Participants 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.	Parkinson's Disease Off Medication n=24 Participants These are the same individuals in the "Parkinson's disease" group, but Off their levodopa
Change in Steps After Postural Perturbation Start Train	2.22 Number of steps Standard Deviation 0.9	2.03 Number of steps Standard Deviation 0.63	2.09 Number of steps Standard Deviation 0.77
Change in Steps After Postural Perturbation End Train	1.92 Number of steps Standard Deviation 1.15	1.15 Number of steps Standard Deviation 0.28	2.05 Number of steps Standard Deviation 1.12

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Parkinsons Disease n=28 Participants 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.	Control n=12 Participants 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.	Parkinson's Disease Off Medication n=24 Participants These are the same individuals in the "Parkinson's disease" group, but Off their levodopa
Change in First Step Length Start of Training	0.18 meters Standard Deviation 0.06	0.25 meters Standard Deviation 0.11	0.21 meters Standard Deviation 0.08
Change in First Step Length End of Training	0.20 meters Standard Deviation 0.08	0.27 meters Standard Deviation 0.08	0.21 meters Standard Deviation 0.08

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Parkinsons Disease n=7 Participants 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.	Control n=7 Participants 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.	Parkinson's Disease Off Medication These are the same individuals in the "Parkinson's disease" group, but Off their levodopa
Cortical Excitability	40.57 % max stim output Standard Deviation 8.73	40.71 % max stim output Standard Deviation 9.97	—

Adverse Events

Parkinsons Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Peterson

Salt Lake City VA

Phone: 6028242279

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place