Parkinson's Disease Clinical Trial
— ParkAIHQOfficial title:
Attributional Style Assessment in Patients With Parkinson's Disease Treated With Deep Brain Stimulation
NCT number | NCT03371277 |
Other study ID # | PO17112 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 22, 2018 |
Est. completion date | July 7, 2018 |
Verified date | October 2018 |
Source | CHU de Reims |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | July 7, 2018 |
Est. primary completion date | July 7, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria : - Diagnostic of Parkinson's disease by a neurologist - Native French speaker - Affiliated to social security - Unmodified PD treatment for at least 2 weeks before the inclusion - Over 18 years-old - Accepting the study after reading the information note and signing the consentment form Exclusion criteria : - 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 |
Country | Name | City | State |
---|---|---|---|
France | Chu Reims | Reims |
Lead Sponsor | Collaborator |
---|---|
CHU de Reims |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Attributional style | The Ambiguous Intentions Hostility Questionnaire (Combs et al., 2006) will be used to assess attributional style | Day 0 | |
Secondary | depression | The Hamilton Depression Rating scale (Hamilton, 1967 )will be used to assess presence of depression | Day 0 |
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