NCT02894333

Brief Summary

The ideomotor theory of action control is considered to be central to the understanding of human voluntary action. According to the ideomotor theory, an action is represented in terms of its desired sensory effects and actions are selected by internally activating these effect representations. Recent imagery and behavioral studies showed that this anticipated representation of action-effects triggered a "sensory attenuation", meaning a decrease of perceptive performances or a decrease of sensory event-related potentials (ERP) for an expected event. Thus, the sensory attenuation constitutes a relevant behavioral tool to investigate sensory anticipation impairment in patients with Parkinson's disease. In a behavioral paradigm, patients and matched control participants have to perform a perceptive task on predicted visual action-effects mixed with mispredicted visual action effects. Performances should be better in mispredicted visual action effects for control participants only.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

December 23, 2019

Status Verified

December 1, 2019

Enrollment Period

2.8 years

First QC Date

September 5, 2016

Last Update Submit

December 20, 2019

Conditions

Keywords

Parkinson's diseaseAction-effect predictionSensory attenuationVoluntary action

Outcome Measures

Primary Outcomes (1)

  • median score

    scores measured with the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    baseline

Study Arms (1)

Patients with Parkinson's disease

Behavioral: behavioral observation

Interventions

Patients with Parkinson's disease

Eligibility Criteria

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

patients with Parkinson's disease

You may qualify if:

  • Parkinson's disease
  • Normal or corrected vision

You may not qualify if:

  • Other pathology or neurological or psychiatric history
  • Known pregnancy or breastfeeding
  • Absence of affiliation to the French Social Security
  • Person under legal protection
  • Patient's opposition to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fondation Adolphe de Rothschild

Paris, 75019, France

Location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Behavior Observation Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychological TechniquesInvestigative TechniquesBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2016

First Posted

September 9, 2016

Study Start

December 1, 2015

Primary Completion

September 1, 2018

Study Completion

September 1, 2019

Last Updated

December 23, 2019

Record last verified: 2019-12

Locations