Clinical trial NCT02600858: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 23
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Task performance (response time) at initial retention, adjusted for baseline (first trial of acquisition on Day 3)
timeFrame: Day 8 (i.e. 48 hours after the last block of training)
Secondary outcomes:
measure: 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)
timeFrame: Day 5, Day 8 (i.e. 48 hours after the last block of training)
measure: 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)
timeFrame: Day 5, Day 15 (i.e. 9 hours after the last block of training)
measure: Rate of improvement
timeFrame: Day 1 through Day 3
measure: Nine hole peg test score
timeFrame: Day 15 (i.e. 9 days after the last block of training)
measure: Buttoning task score
timeFrame: Day 15 (i.e. 9 days after the last block of training)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Lee Dibble, PhD
role: PRINCIPAL_INVESTIGATOR
References: