Exogenous Effects of Standard Medical Care (Dopamine) on Motor Learning of an Upper Limb Task in Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

Exogenous Effects of Standard Medical Care (Dopamine) on Motor Learning of an Upper Limb Task in Parkinson Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600858
• Other study ID #: IRB_00085073_UL
• Status: Completed
• Phase: N/A
• First received: November 5, 2015
• Last updated: February 20, 2018
• Start date: January 2016
• Est. completion date: January 2017

Study information

• Verified date: February 2018
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Upper limb feeding training
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.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Task performance (response time) at initial retention, adjusted for baseline (first trial of acquisition on Day 3)		Day 8 (i.e. 48 hours after the last block of training)
Secondary	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)		Day 5, Day 8 (i.e. 48 hours after the last block of training)
Secondary	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)		Day 5, Day 15 (i.e. 9 hours after the last block of training)
Secondary	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).	Day 1 through Day 3
Secondary	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)	Day 15 (i.e. 9 days after the last block of training)
Secondary	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)	Day 15 (i.e. 9 days after the last block of training)