Exogenous Effects of Standard Medical Care (Dopamine) on Motor Learning of an Upper Limb Task in Parkinson Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Upper limb feeding training
Sponsored by
About this trial
This is an interventional supportive care trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Idiopathic Parkinson's disease confirmed by neurologist
- Hoehn and Yahr stages 1 to 3
- On a stable dose of antiparkinsonian medication for the past month and will continue on this regime for at least another subsequent month
- Walks unaided
Exclusion Criteria:
- Not taking dopamine replacement therapy
- With prior surgical management for PD (e.g. deep brain stimulation)
- With medication-resistant freezing of gait
- Significant cognitive impairment (Montreal Cognitive Assessment score <18)
- Unstable medical conditions
- Other neurological conditions
- Unable to follow instructions or safely complete the training tasks
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Training "off" medication
Training "on" medication
Arm Description
Participants will train on the upper limb feeding task before taking their first daily dose of standard dopamine medication for Parkinson's disease, i.e. while "off" dopamine replacement medication
Participants will train on the upper limb feeding task after taking their first daily dose of standard dopamine medication for Parkinson's disease, i.e. while "on" dopamine replacement medication
Outcomes
Primary Outcome Measures
Task performance (response time) at initial retention, adjusted for baseline (first trial of acquisition on Day 3)
Secondary Outcome Measures
Immediate decrement (difference in response time between initial retention and the last trial of acquisition) in task performance, adjusted for baseline (first trial of acquisition)
Delayed decrement (difference in response time between delayed retention and the last trial of acquisition) in task performance, adjusted for baseline (first trial of acquisition)
Rate of improvement
Rate of improvement (c) modelled on the exponential decay function: y = a + be(exp[-x/c]), where a is the final trial time value that the exponential decay function approaches (ie, asymptote), b is the scale of the learning from the first trial time to the value a, x is the trial number, 1/c is the number of trials needed to obtain asymptote (ie, 1 - e-1).
Nine hole peg test score
Time taken to complete the Nine Hole Peg Test at delayed retention, adjusted for baseline (Nine Hole Peg Test score at baseline, i.e. 3 days prior to the first block of training)
Buttoning task score
Time taken to complete the Buttoning task at delayed retention, adjusted for baseline (Buttoning task score at baseline, i.e. 3 days prior to the first block of training)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02600858
Brief Title
Exogenous Effects of Standard Medical Care (Dopamine) on Motor Learning of an Upper Limb Task in Parkinson Disease
Official Title
Exogenous Effects of Standard Medical Care (Dopamine) on Motor Learning of an Upper Limb Task in Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study determines whether standard medical care (dopamine) affects learning and retention of an upper limb feeding task in people with Parkinson's disease (PD) and whether training on the feeding task generalises to performance on an untrained upper limb buttoning task. Half the participants will train on the feeding task after they have taken their first dose of dopamine for the day (i.e. "on" medication state), while the other half will train on the same feeding task before taking their first daily dose of dopamine (i.e. "off" medication state).
Detailed Description
Parkinson disease (PD) is an age related neurodegenerative disorder with symptomatic declines in motor function due to a loss of dopaminergic neurons within the basal ganglia.
Ironically, treatment with exogenous dopamine-replacement medication (e.g. levodopa) may have positive effects on existing motor skills such as handwriting or walking, but may have detrimental effects on the learning of motor skills necessary for effective rehabilitation.
Although dopamine medications are routinely prescribed to replace lost dopamine in the sensorimotor areas of the striatum, they may actually be "overdosing" the associative striatum, a candidate neuroanatomical correlate for motor learning. To date, however, this 'overdose' hypothesis has not been widely tested, given that few studies of motor learning in PD have reported or controlled for whether individuals were tested "on" or "off" their dopamine replacement medication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training "off" medication
Arm Type
Experimental
Arm Description
Participants will train on the upper limb feeding task before taking their first daily dose of standard dopamine medication for Parkinson's disease, i.e. while "off" dopamine replacement medication
Arm Title
Training "on" medication
Arm Type
Other
Arm Description
Participants will train on the upper limb feeding task after taking their first daily dose of standard dopamine medication for Parkinson's disease, i.e. while "on" dopamine replacement medication
Intervention Type
Behavioral
Intervention Name(s)
Upper limb feeding training
Intervention Description
Participants will spoon two raw kidney beans at a time from a center proximal "start" cup to three distal "target" cups positioned 16 cm away at 45°, 90° and 135° around the start cup as fast as possible using their non-dominant hand. Spooning two beans between the start cup and a target cup is considered one repetition; each trial will consist of 15 repetitions. Participants will perform 50 trials per day for 3 consecutive days.
Primary Outcome Measure Information:
Title
Task performance (response time) at initial retention, adjusted for baseline (first trial of acquisition on Day 3)
Time Frame
Day 8 (i.e. 48 hours after the last block of training)
Secondary Outcome Measure Information:
Title
Immediate decrement (difference in response time between initial retention and the last trial of acquisition) in task performance, adjusted for baseline (first trial of acquisition)
Time Frame
Day 5, Day 8 (i.e. 48 hours after the last block of training)
Title
Delayed decrement (difference in response time between delayed retention and the last trial of acquisition) in task performance, adjusted for baseline (first trial of acquisition)
Time Frame
Day 5, Day 15 (i.e. 9 hours after the last block of training)
Title
Rate of improvement
Description
Rate of improvement (c) modelled on the exponential decay function: y = a + be(exp[-x/c]), where a is the final trial time value that the exponential decay function approaches (ie, asymptote), b is the scale of the learning from the first trial time to the value a, x is the trial number, 1/c is the number of trials needed to obtain asymptote (ie, 1 - e-1).
Time Frame
Day 1 through Day 3
Title
Nine hole peg test score
Description
Time taken to complete the Nine Hole Peg Test at delayed retention, adjusted for baseline (Nine Hole Peg Test score at baseline, i.e. 3 days prior to the first block of training)
Time Frame
Day 15 (i.e. 9 days after the last block of training)
Title
Buttoning task score
Description
Time taken to complete the Buttoning task at delayed retention, adjusted for baseline (Buttoning task score at baseline, i.e. 3 days prior to the first block of training)
Time Frame
Day 15 (i.e. 9 days after the last block of training)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Idiopathic Parkinson's disease confirmed by neurologist
Hoehn and Yahr stages 1 to 3
On a stable dose of antiparkinsonian medication for the past month and will continue on this regime for at least another subsequent month
Walks unaided
Exclusion Criteria:
Not taking dopamine replacement therapy
With prior surgical management for PD (e.g. deep brain stimulation)
With medication-resistant freezing of gait
Significant cognitive impairment (Montreal Cognitive Assessment score <18)
Unstable medical conditions
Other neurological conditions
Unable to follow instructions or safely complete the training tasks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Dibble, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
12. IPD Sharing Statement
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Exogenous Effects of Standard Medical Care (Dopamine) on Motor Learning of an Upper Limb Task in Parkinson Disease
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