NCT02288052

Brief Summary

The basal ganglia play an important role in motor learning, especially during the consolidation phase of motor learning. This raises the question whether it is possible to sustain learning increments in a neurodegenerative condition such as Parkinson's disease (PD). The aim of this study is to gain knowledge on whether it is possible to relearn skills which are actually affected by PD, such as writing, and determine whether neuroplasticity is possible. In this randomized controlled study, PD patients will either follow intensive writing training or a placebo treatment (stretch and relaxation training) during 6 weeks. The writing training will focus on automatization (withstanding dual task interference), transfer to an untrained task and retention. The placebo program is aimed to reduce stiffness in the upper limbs and has been shown to be ineffective in PD. To date, it is unknown how neural networks change as a result of consolidation after a prolonged period of motor learning in PD. Therefore the second arm of this study will investigate, for the first time, changes in neural connectivity using brain imaging data to elucidate which neuroanatomical regions are involved in consolidation of learning in PD. Finally, DTI and resting state fMRI-analysis will complement insights into the neural changes as a result of learning.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

3 years

First QC Date

November 3, 2014

Last Update Submit

January 27, 2016

Conditions

Parkinson Disease

Keywords

HandwritingMotor learning

Outcome Measures

Primary Outcomes (5)

  • Change from baseline in writing amplitude (cm) on tablet after 6 weeks of training

    Analysis based on measurement of XYZ coordinates, measured at a spatial resolution of 32.5 μm.

    6 weeks

  • Change from baseline in writing amplitude (cm) on tablet after 12 weeks, including 6 weeks without training

    Analysis based on measurement of XYZ coordinates, measured at a spatial resolution of 32.5 μm.

    12 weeks

  • Change from baseline in brain activity during writing (functional MRI) after 6 weeks of training

    Analysis of the change in Blood Oxygen Level Dependent (BOLD) response

    6 weeks

  • Change from baseline in brain activity during rest (resting state MRI) after 6 weeks of training

    Analysis of the change in Blood Oxygen Level Dependent (BOLD) response

    6 weeks

  • Change from baseline in Diffusion Tensor Imaging after 6 weeks of training

    Analysis of the change in Blood Oxygen Level Dependent (BOLD) response

    6 weeks

Secondary Outcomes (12)

  • Transfer of change in writing amplitude to an untrained writing sequence after 6 weeks of training

    6 weeks

  • Transfer of change in writing amplitude to an untrained writing sequence after 12 weeks, including 6 weeks without training

    12 weeks

  • Change from baseline in dual task effect (DTE) for writing amplitude after 6 weeks of training

    6 weeks

  • Change from baseline in dual task effect (DTE) for writing amplitude after 12 weeks, including 6 weeks without training

    12 weeks

  • Change from baseline in writing fluency (normalized jerk) on tablet after 6 weeks of training

    6 weeks

  • +7 more secondary outcomes

Study Arms (2)

Writing program

EXPERIMENTAL

The program will train participants in maintaining writing amplitude, writing speed, writing fluently and automatization of writing.

Behavioral: Writing program

Stretch & Relaxation program

PLACEBO COMPARATOR

The program will learn participants to alleviate tension in the upper limbs and will consist of exercises performed while lying down or sitting.

Behavioral: Stretch & Relaxation program

Interventions

Writing programBEHAVIORAL

6 weeks of at-home training (5days/week, 30minutes/day) using both pen-and-paper exercises and exercises on a writing tablet.

Writing program
Stretch & Relaxation programBEHAVIORAL

6 weeks of at-home training (5days/week, 30minutes/day) using a DVD with exercises.

Stretch & Relaxation program

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of PD based on the UK Brain Bank criteria
  • Hoehn \& Yahr stage I (with impairments on the right side) and II in the on-phase
  • Without cognitive impairment (MMSE \>24)
  • On stable medication
  • Right handed

You may not qualify if:

  • Deep Brain Stimulator
  • Other contra-indications for MR scanning
  • Colorblind

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Sciences KU Leuven

Leuven, 3001, Belgium

Location

Related Publications (2)

  • Broeder S, Nackaerts E, Nieuwboer A, Smits-Engelsman BC, Swinnen SP, Heremans E. The effects of dual tasking on handwriting in patients with Parkinson's disease. Neuroscience. 2014 Mar 28;263:193-202. doi: 10.1016/j.neuroscience.2014.01.019. Epub 2014 Jan 19.

    PMID: 24447597BACKGROUND

  • Nackaerts E, Vervoort G, Heremans E, Smits-Engelsman BC, Swinnen SP, Nieuwboer A. Relearning of writing skills in Parkinson's disease: a literature review on influential factors and optimal strategies. Neurosci Biobehav Rev. 2013 Mar;37(3):349-57. doi: 10.1016/j.neubiorev.2013.01.015. Epub 2013 Jan 16.

    PMID: 23333265BACKGROUND

Related Links

MeSH Terms

Conditions

Parkinson Disease

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Alice Nieuwboer, Professor

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 3, 2014

First Posted

November 11, 2014

Study Start

January 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

BE(1)