The Impact of Standard Medical Care (Dopamine) and Practice on Postural Motor Learning in Parkinson's Disease

NCT02593812 | Completed

• 1 other identifier: IRB_00085073
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson Disease

Keywords

Learning; Practice

Outcome Measures

Primary Outcomes (2)

• General task performance (response time of the random sequence) at initial retention, adjusted for baseline

  Response time of the random sequence within initial retention trial, adjusted for baseline (i.e. the first trial of acquisition on Day 3)

  Day 8 (i.e. 48 hours after the last block of training)

• Implicit sequence learning (difference in response time between the random and repeated sequences) at initial retention, adjusted for baseline

  The difference in response time between the random and repeated sequences of the initial retention trial, adjusted for baseline (i.e. the first trial of acquisition on Day 3)

  Day 8 (i.e. 48 hours after the last block of training)

Secondary Outcomes (6)

• Immediate decrement (difference in response time between initial retention and the last trial of acquisition) in general task performance, adjusted for baseline

  Day 5, Day 8 (i.e. 48 hours after the last block of training)

• Delayed decrement (difference in response time between delayed retention and the last trial of acquisition) in general task performance, adjusted for baseline

  Day 5, Day 13-15 (i.e. at least 7 days after the last block of training)

• 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

  Day 5, Day 8 (i.e. 48 hours after the last block of training)

• 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

  Day 5, Day 13-15 (i.e. at least 7 days after the last block of training)

• Four Square Step test score, adjusted for baseline

  Day 13-15 (i.e. at least 7 days after the last block of training)

Study Arms (2)

Training "off" medication

EXPERIMENTAL

Participants will train on the postural stepping task before taking their first daily dose of standard Parkinson's medication (dopamine), i.e. while "off" dopamine replacement medication

Behavioral: Stepping training

Training "on" medication

OTHER

Participants will train on the postural stepping task after taking their first daily dose of standard Parkinson's medication (dopamine), i.e. while "on" dopamine replacement medication

Behavioral: Stepping training

Interventions

Stepping training BEHAVIORAL

Participants will step rapidly to one of four cued targets. Each trial will consist of 24 steps. Participants will perform 6 blocks of 6 trials per day for 3 consecutive days.

Training "off" medication; Training "on" medication

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• American Parkinson's Disease Association, Inc: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Serene S Paul, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Associate

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 2, 2015
• Study Start: July 1, 2016
• Primary Completion: May 11, 2017
• Study Completion: May 11, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

US (1)