NCT04269590

Brief Summary

Parkinson's disease (PD) is characterized by severe motor symptoms, including upper limb dysfunction, that is only partially alleviated by medication. PD is also a motor learning disease due to the degradation of the striatum, involved in the consolidation of motor memory. We showed earlier that motor practice improves writing deficits and that there is long term potential when it is applied in a focused manner. However, retention difficulties were also apparent. What is currently unclear, is which learning method leads to optimal retention in PD and how it is expressed in underlying neural network changes. In healthy controls, retention is improved by incorporating dual task (DT) conditions or by loading cognition during learning. Our own work showed that DT training also led to better retention than single task (ST) learning, at least in a subgroup of PD. Using a combination of behavioral assessment, functional magnetic resonance imaging and upper limb task training, this project aims to understand how to boost the robustness of practice in PD. Throughout, we will contrast ST with DT learning. As complex practice can now easily be delivered via novel technology, this study will set out future avenues for rehabilitation targeted at specific neural circuitry.

Trial Health

87
On Track

Trial Health Score

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

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
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

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 3, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2023

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

February 10, 2020

Last Update Submit

December 10, 2025

Conditions

Keywords

Neurologic rehabilitationDual taskingMotor learning

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 training types (ST vs DT) and groups (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 training types (ST vs DT), groups (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), between training types (ST vs DT) and groups (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), between training types (ST vs DT) and groups (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 (4)

Dual Task (DT) training - PD

EXPERIMENTAL

Combination of practicing the Swipe Slide Pattern task and a secondary task for a group of patients with Parkinson's disease (PD)

Behavioral: Dual Task (DT) training

Single Task (ST) training - PD

ACTIVE COMPARATOR

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

Behavioral: Single Task (ST) training

Dual Task (DT) training - HC

EXPERIMENTAL

Combination of practicing the Swipe Slide Pattern task and a secondary task for a group of healthy age-matched controls.

Behavioral: Dual Task (DT) training

Single Task (ST) training - HC

ACTIVE COMPARATOR

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

Behavioral: Single Task (ST) training

Interventions

Participants will practice the Swipe Slide Pattern (SSP) task without the presence of a secondary 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.

Single Task (ST) training - HCSingle Task (ST) training - PD

Participants will practice the Swipe Slide Pattern (SSP) task in combination with a secondary task, i.e. counting red or green lights. On day 1, participants perform 2 runs of the SSP-task (only one pattern), each lasting approx. 10 min, within an MR scanner. During each run, 9 trials of 30s are performed, alternated with rest periods of 14s. Instructions are provided before each trial (i.e. view of the pattern in combination with instruction to count red or green lights, 4s), as well as an answer option (i.e. participants have to indicate how many red or green lights they counted by circling a number from zero to nine, 6s). For the following 4 days, participants will continue practice of the SSP-task at home. During the at-home-sessions, participants will perform 9 trials of 12 patterns each, alternated with rest periods of 14s. Instruction and answers are also included. During at home practice, the same pattern as during scans is included, in combination with 2 new patterns.

Dual Task (DT) training - HCDual Task (DT) training - 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
  • Hoehn and Yahr (H\&Y) stage I-III
  • Without a history of intervening co-morbidities
  • Right handed
  • Participants in H\&Y stage I should have the right side as the most affected side

You may not qualify if:

  • Cognitive decline (Mini Mental State Examination \< 24)
  • Visual impairments that impede the following of visual targets
  • Comorbidities of the upper limb that could interfere with the study and are not caused by Parkinson's disease
  • Contra-dinidcations for Magnetic Resonance Imaging (MRI)
  • 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, Belgium

Location

Related Publications (3)

  • 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

MeSH Terms

Conditions

Parkinson Disease

Interventions

potassium channel subfamily K member 3

Condition Hierarchy (Ancestors)

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

Study Officials

  • Alice Nieuwboer, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
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 3, 2021

Primary Completion

May 16, 2023

Study Completion

May 16, 2023

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations