Subthalamic Nucleus Stimulation Electrode and Psychiatric Lesion Effects in Parkinson's Disease

Parkinson Disease Clinical Trial

— PSYLES-STIM  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06389903
• Other study ID #: 2018-A00185-50
• Status: Completed
• Phase: N/A
• Start date: June 4, 2019
• Est. completion date: October 5, 2021

Study information

• Verified date: April 2024
• Source: Centre Hospitalier du Rouvray
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 5, 2021
• Est. primary completion date: July 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• assessment
post-surgery behavioral assessment using scales

Locations

Country	Name	City	State
France	Marie Desbordes, MD	Sotteville Les Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier du Rouvray

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Assessment of personality	Big Five inventory. The test identified five factors as follows : openness to experience (inventive/curious vs. consistent/cautious); conscientiousness (efficient/organized vs. extravagant/careless); extraversion (outgoing/energetic vs. solitary/reserved); agreeableness (friendly/compassionate vs. critical/judgmental); neuroticism (sensitive/nervous vs. resilient/confident)	Baseline
Secondary	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
Secondary	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