NCT03371277

Brief Summary

Parkinson's disease (PD) is a common neurodegenerative disorder affecting 1-2% of the population over 65 years-old. In addition to the motor impairment characterized by resting tremor, bradykinesia, rigidity and postural instability, patients suffer with non-motor symptoms such as dysautonomia syndrome, sleep disturbances, depressive disorders, delusional disorders and cognitive disorders. Research and management of these non-motor symptoms is essential because these can be disabling and have a negative impact on the quality of life of patients. Among cognitive functions, social cognition is defined as the aspect that is dedicated to process social information for adaptive functioning. More specifically, it refers to an intricate set of higher-order neuropsychological domains that allow for adaptive behaviors in response to others. Four dimensions are usually included in this construct: theory of mind (ToM), emotion processing, social perception and social knowledge, and attributional style. Recently, different categories of social cognition have been studied in patients suffering from PD, such as the ToM or the recognition of facial emotions. Other aspects of social cognition that seem relevant in this population are still poorly studied; the attributional style is a cognitive bias defined as "the way we explain the causes of the positive or negative events that occur". Indeed, different causes can be attributed to an event, and this attribution is shared between oneself, others and other factors related to the situation. People with attribution bias may mistakenly attribute to one cause all the situations. For example, when an individual blame the others for an event, he may develop a feeling of hostility that may lead to maladaptive behavior such as aggression and thus affect his social functioning. The impact of PD treatments, particularly deep brain stimulation (DBS), on the ToM has been studied, showing a deficit after stimulation. No study has assessed the impact of therapeutics on the attributional style of PD patients. In this context, it seems relevant to evaluate the effect of deep brain stimulation on the attributional style in this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

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

December 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 22, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2018

Completed
Last Updated

January 21, 2026

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

December 7, 2017

Last Update Submit

January 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Attributional style

    The Ambiguous Intentions Hostility Questionnaire (Combs et al., 2006) will be used to assess attributional style

    Day 0

Secondary Outcomes (1)

  • depression

    Day 0

Study Arms (2)

Arm1

EXPERIMENTAL

patients with Parkinson's disease treated with deep brain stimulation.

Other: Medical visit for specific questionnaires

Arm2

EXPERIMENTAL

patients with Parkinson's disease treated without deep brain stimulation.

Other: Medical visit for specific questionnaires

Interventions

Ambiguous Intentions Hostility Questionnaire (AIHQ) developed by Combs (2007)

Arm1Arm2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnostic of Parkinson's disease by a neurologist
  • Native French speaker
  • Affiliated to social security
  • Over 18 years-old
  • Accepting the study after reading the information note and signing the consentment form

You may not qualify if:

  • Diagnostic of bipolar disorder or schizophrenia
  • Abuse and dependence on psychoactive substances according to the DSM V criteria
  • Disabling sensory disorders
  • Mental retardation or cognitive deterioration (e.g. dementia), with the incapacity to answer to the questionnaires.
  • Patients under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

Related Publications (1)

  • Decombe L, Henry A, Decombe R, Tir M, Doe de Maindreville A, Galland Hairabedian L, Kaladjian A, Raucher-Chene D. "Accidental, really?" Attributional bias in patients with Parkinson's disease. Parkinsonism Relat Disord. 2022 Feb;95:18-22. doi: 10.1016/j.parkreldis.2021.12.013. Epub 2021 Dec 23.

    PMID: 34959046BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 13, 2017

Study Start

January 22, 2018

Primary Completion

July 7, 2018

Study Completion

July 7, 2018

Last Updated

January 21, 2026

Record last verified: 2018-10

Locations