NCT04269577

Brief Summary

Parkinson's disease (PD) is characterized by severe motor symptoms that can only be partially alleviated by medication. It was shown previously that rehabilitation is an important therapeutic supplement for micrographia in early disease. However, what is unknown is how motor learning impacts on the underlying neural networks in patients with different disease progression and how this interacts with dopaminergic medication. Furthermore, difficulties with upper limb motor control has a severe impact on the daily lives of PD patients since fine motor skills become increasingly important for the use of smartphones and tablets. Therefore, the current project will include a newly developed Swipe-Slide Pattern test, resembling the pattern codes used to unlock smartphones and tablets. This task will be used to determine learning-induced neuroplasticity of cortico-striatal effective connectivity across disease stages in PD. Using a combination of behavioral assessment and functional magnetic resonance imaging, the investigators aim to contribute to the understanding of upper limb motor learning in patients with PD for the development of individualized rehabilitation programs.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started May 2021

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2.8 years

First QC Date

February 10, 2020

Last Update Submit

November 16, 2023

Conditions

Keywords

Neurologic rehabilitationMotor learningDisease progression

Outcome Measures

Primary Outcomes (5)

  • Change in movement time (s) of trained pattern

    Using the behavioral data gathered during task-based fMRI, the learning index and retention index, as described in Nackaerts et al. 2020, will be determined and compared between groups (early PD vs mid PD vs HC).

    7 days

  • Change in dual task effect

    Using the behavioral data gathered before and immediately after task-based fMRI, as well as at immediate and delayed retention, dual task interference will be calculated and compared between groups (early PD vs mid PD vs HC) and time points

    7 days

  • Change in brain activity during performance of trained pattern

    The BOLD activity pattern will be determined and compared between the 3 training phases (i.e. early learning, late learning and retention) and groups (early PD vs mid PD vs HC).

    7 days

  • Change in brain connectivity during performance of trained pattern

    The BOLD activity pattern will be determined and connectivity measures will be extracted. Neural network changes will be compared between the 3 training phases (i.e. early learning, late learning and retention) and groups (early PD vs mid PD vs HC).

    7 days

  • Diffusion weighted imaging as a predictor

    Anatomical connectivity at baseline will be calculated and investigated as a predictive factor for learning capacity.

    7 days

Secondary Outcomes (5)

  • Change in Euclidean distance of trained pattern

    7 days

  • Change in movement time (s) of the untrained pattern

    7 days

  • Change in Euclidean distance of the untrained pattern

    7 days

  • Change in brain activity during performance of untrained pattern

    7 days

  • Change in brain connectivity during performance of untrained pattern

    7 days

Study Arms (3)

SSP training - early PD

EXPERIMENTAL

Practice of the Swipe Slide Pattern task alone for a group of patients with early Parkinson's disease (PD)

Behavioral: SSP training

SSP training - mid PD

EXPERIMENTAL

Practice of the Swipe Slide Pattern task alone for a group of patients with mid-stage Parkinson's disease (PD)

Behavioral: SSP training

SSP training - HC

EXPERIMENTAL

Practice of the Swipe Slide Pattern task alone for a group of healthy age-matched controls (HC)

Behavioral: SSP training

Interventions

SSP trainingBEHAVIORAL

Participants will practice the Swipe Slide Pattern (SSP) task. On day 1, participants perform two runs of the SSP-task (only one pattern), each lasting approx. 10 min, within an MR scanner. During each run, nine trials of 30s are performed, alternated with rest periods of 14s. In addition, instructions are provided before each trial (i.e. view of the pattern, 4s), as well as an answer option (i.e. participants have circle a random number from zero to nine, 6s). For the following four days (day 2-5), participants will continue practice of the SSP-task at home. During the at-home-sessions, participants will perform nine trials of 12 patterns each, alternated with rest periods of 14s. Instruction are also included. During at home practice, the same pattern as during scans is included, in combination with two new patterns.

SSP training - HCSSP training - early PDSSP training - mid PD

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Parkinson's disease based on the 'UK Brain Bank' criteria
  • Right handed
  • No dementia (Mini Mental State Examination \> 24/30)
  • Early PD group: disease duration of ≤ 2 year since appearance of first symptoms in combination with a maximum score of 2 on each of the upper limb items of the MDS-UPDRS-III
  • Mid stage PD group: patients are considered as mid-stage in case one of the criteria for early PD is not fulfilled

You may not qualify if:

  • Comorbidities of the upper limb that could interfere with the study and are not caused by Parkinson's disease (e.g. arthritis, fractures of the hand, etc.)
  • Other medical or psychiatric impairments that could interfere with the study protocol
  • Contra-indications for Magnetic Resonance Imaging
  • Tremor of the head or right hand, as determined by the Movement Disorders Society Unified Parkinson's disease Rating scale part III
  • Color blindness as determined by the Ishihara test for color deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Sciences KU Leuven

Leuven, 3001, Belgium

Location

Related Publications (4)

  • Nackaerts E, Ginis P, Heremans E, Swinnen SP, Vandenberghe W, Nieuwboer A. Retention of touchscreen skills is compromised in Parkinson's disease. Behav Brain Res. 2020 Jan 27;378:112265. doi: 10.1016/j.bbr.2019.112265. Epub 2019 Sep 27.

    PMID: 31568836BACKGROUND
  • Lin CH, Chiang MC, Wu AD, Iacoboni M, Udompholkul P, Yazdanshenas O, Knowlton BJ. Age related differences in the neural substrates of motor sequence learning after interleaved and repetitive practice. Neuroimage. 2012 Sep;62(3):2007-20. doi: 10.1016/j.neuroimage.2012.05.015. Epub 2012 May 11.

    PMID: 22584226BACKGROUND
  • Sidaway B, Ala B, Baughman K, Glidden J, Cowie S, Peabody A, Roundy D, Spaulding J, Stephens R, Wright DL. Contextual Interference Can Facilitate Motor Learning in Older Adults and in Individuals With Parkinson's Disease. J Mot Behav. 2016 Nov-Dec;48(6):509-518. doi: 10.1080/00222895.2016.1152221. Epub 2016 Jun 24.

    PMID: 27340809BACKGROUND
  • Dan X, King BR, Doyon J, Chan P. Motor Sequence Learning and Consolidation in Unilateral De Novo Patients with Parkinson's Disease. PLoS One. 2015 Jul 29;10(7):e0134291. doi: 10.1371/journal.pone.0134291. eCollection 2015.

    PMID: 26222151BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseDisease Progression

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alice Nieuwboer, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 17, 2020

Study Start

May 10, 2021

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations