Study of Symptoms Related to the Lesion Effect Associated With the Implantation of Electrodes for Stimulation of the Subthalamic Nuclei in the Treatment of Parkinson's Disease.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Centre Hospitalier du Rouvray
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Assessment of change of mania symptoms
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a pilot, prospective, monocentric study concerning 15 Parkinson's disease patients requiring deep brain stimulation implantation.
The primary objective is to evaluate the psychiatric lesion effects of deep brain stimulation in patients with Parkinson's disease, using the Young Mania Rating Scale (YMRS), Big Five Inventory and the Hamilton Depression Rating Scale (HAMD 21).
Detailed Description
The patients included were adults suffering from Parkinson's disease (according to ICD-10). They had no severe psychiatric disorders, and no major neurocognitive disorders contraindicating surgery. An initial evaluation will be carried out 72 hours after surgery, then after one month, and finally 3 months after surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Major patient
- •Diagnosis of Parkinson's disease (ICD-10)
- •L-dopa test must be positive
- •Participants who gave their informed, written consent
Exclusion Criteria
- •Severe psychiatric disorder
- •Major neurocognitive disorder contraindicating surgery
Outcomes
Primary Outcomes
Assessment of change of mania symptoms
Time Frame: Baseline, 72 hours, 1 month and 3 months after surgery
The variation of Young Mania Rating Scale (YMRS). The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania.
Secondary Outcomes
- Assessment of confusion(72 hours and 3 months after surgery)
- Assessment of change of depressive symptoms(Baseline, 72 hours, 1 month and 3 months after surgery)
- Assessment of change of Impulsivity(Baseline, 72 hours, 1 month and 3 months after surgery)
- Assessment of change of Behavior(Baseline, 72 hours, 1 month and 3 months after surgery)
- Assessment of change of Apathy(Baseline, 72 hours, 1 month and 3 months after surgery)
- Assessment of personality(Baseline)
- Assessment of executive functions(Baseline, 72 hours, 3 months after surgery)