NCT05908266

Brief Summary

Current research and theories have highlighted that the parameters linked to movement planning, e.g. the decision to select a movement goal, and adaptation, e.g. the ability to update control dependent on a novel dynamical context, are update quickly and within an ongoing movement in the general population. In parallel, it has been suggested that the evaluation of movement costs is a function of the basal ganglia, and it is impaired in Parkinson disease (PD). Here the investigators want to test whether these mechanisms also alter the ability of patients to update control during an ongoing action. A positive result would confirm that movement-related costs and dynamical representations depend on the integrity of the basal ganglia, in contrast a negative result would indicate that the deficit in PD is more specifically related to movement initiation, which would invite one to reconsider the cause of bradykinesia in this population.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress67%
May 2023Oct 2027

Study Start

First participant enrolled

May 1, 2023

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

4.5 years

First QC Date

May 25, 2023

Last Update Submit

June 8, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Kinematics

    Position of the handle as a function of time. Units are millimetres

    Measured during the entire experiment (an average of 4.5 years)

  • Surface Electromyogram

    Surface recordings of muscles activities from the main muscles involved in movement production. Units are volts

    Measured during the entire experiment (an average of 4.5 years)

  • Applied forces

    Forces applied by participants on the robotic handle. Units are Newtons

    Measured during the entire experiment (an average of 4.5 years)

Study Arms (2)

PD

Patients with Parkinson disease

Other: Reaching movementsOther: Disease Assessment

Control

Healthy volunteers

Other: Reaching movements

Interventions

Participants will be instructed to perform reaching movements by moving the handle of a robotic arm mounted with a virtual reality display.

ControlPD

Disease stage assessed by trained professionals

PD

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will be based on two populations: on population of volunteers with Parkinson disease, and one population of age and sex matched healthy individuals.

You may qualify if:

  • Ability to perform the task (assessed during the experiment)

You may not qualify if:

  • Inability to perform the task (motor) or to understand the task requirements (cognitive)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université catholique de Louvain

Louvain-la-Neuve, 1348, Belgium

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Frédéric Crevecoeur, PhD

    Université Catholique de Louvain

    STUDY DIRECTOR

Central Study Contacts

Frédéric Crevecoeur, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 18, 2023

Study Start

May 1, 2023

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations