Clinical trial NCT02593812: The Impact of Standard Medical Care (Dopamine) and Practice on Postural Motor Learning in Parkinson's Disease
Official title: The Impact of Standard Medical Care (Dopamine) and Practice on Postural Motor Learning in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Learning
Practice
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: American Parkinson's Disease Association, Inc
First posted: 2015-11-01
Enrollment: 27
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 a postural stepping task in people with Parkinson's disease (PD) and whether training on a postural stepping task generalises to performance on an untrained postural task. Half the participants will train on the stepping 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 stepping task before taking their first daily dose of dopamine (i.e. "off" medication state).

Detailed description: Motor learning is critical for acquiring new skills and adapting behaviour, therefore the success of rehabilitation depends on successful motor learning through practice. Motor learning involves the basal ganglia, including both the associative and sensorimotor striatum. Although people with PD are capable of motor learning, they are less efficient and do not achieve the same extent of skill acquisition and retention as people without neurological deficit.

Reductions in endogenous dopamine and reduced dopamine binding associated with loss of dopaminergic receptors due to disease progression may impair motor learning in people with PD. Conflicting evidence suggests that impaired motor learning in PD is due on the one hand to the absence of dopamine but on the other hand to "overdosing" of the basal ganglia with dopamine replacement therapy which suppresses activation of the associative striatum during the early acquisition stages of motor learning.

Understanding which factors improve or degrade motor learning of tasks will allow rehabilitation parameters to be adjusted around standard medical care in order to optimize learning and improve the efficacy of exercise interventions for people with PD. In particular, successful learning of postural tasks that challenge stability may in turn reduce falls.

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: General task performance (response time of the random sequence) at initial retention, adjusted for baseline
timeFrame: Day 8 (i.e. 48 hours after the last block of training)
measure: Implicit sequence learning (difference in response time between the random and repeated sequences) at initial retention, adjusted for baseline
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 general task performance, adjusted for baseline
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 general task performance, adjusted for baseline
timeFrame: Day 5, Day 13-15 (i.e. at least 7 days after the last block of training)
measure: Immediate decrement (difference in response time between initial retention and the last trial of acquisition) in implicit sequence learning (difference in response time between the random and repeated sequences), adjusted for baseline
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 implicit sequence learning (difference in response time between the random and repeated sequences), adjusted for baseline
timeFrame: Day 5, Day 13-15 (i.e. at least 7 days after the last block of training)
measure: Four Square Step test score, adjusted for baseline
timeFrame: Day 13-15 (i.e. at least 7 days after the last block of training)
measure: MiniBEST score, adjusted for baseline
timeFrame: Day 13-15 (i.e. at least 7 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: Serene S Paul, PhD
role: PRINCIPAL_INVESTIGATOR
References: