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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavorial Assessment | Experimental | post-surgery behavioral assessment using scales |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| assessment | Behavioral | post-surgery behavioral assessment using scales |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of change of mania symptoms | The variation of Young Mania Rating Scale (YMRS). The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania. | Baseline, 72 hours, 1 month and 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of change of depressive symptoms | The variation of Hamilton Rating Scale for Depression (HAMD-21). HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). | Baseline, 72 hours, 1 month and 3 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marie Desbordes, MD | Sotteville-lès-Rouen | 76300 | France |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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| Assessment of change of Behavior | The variation of the Ardouin Scale of Behavior in Parkinson's Disease. The total score ranges from 0 to 84. Higher score mean worse outcome. | Baseline, 72 hours, 1 month and 3 months after surgery |
| Assessment of change of Impulsivity | The variation of the Dickman Impulsivity Inventory. It is a self report measure assessing dysfunctional impulsivity and functional impulsivity. Regarding dysfunctional impulsivity (12 items), higher score mean worse adaptation. Regarding functional impulsivity (11 items), higher score mean better adaptation. | Baseline, 72 hours, 1 month and 3 months after surgery |
| Assessment of change of Apathy | The variation of the Apathy Evaluation Scale. This 18 item scale ranges from 0 to 12. Higher score means worse outcome. | Baseline, 72 hours, 1 month and 3 months after surgery |
| Assessment of personality | Big Five inventory. The test identified five factors as follows :
| Baseline |
| Assessment of executive functions | Frontal Assessment Battery at Bedside. Thebattery consists of six subtests exploring the following: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. | Baseline, 72 hours, 3 months after surgery |
| Assessment of confusion | Confusion Assessment method (CAM). The CAM instrument assesses the presence, severity, and fluctuation of 9 delirium features: acute onset, inattention, disorganized thinking, altered level of consciousness, disorientation, memory impairment, perceptual disturbances, psychomotor agitation or retardation, and altered sleep-wake cycle. | 72 hours and 3 months after surgery |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |