Subthalamic Nucleus Stimulation Electrode and Psychiatric Lesion Effects in Parkinson's Disease (PSYLES-STIM)

Centre Hospitalier du Rouvray

Status: Completed

Conditions: Parkinson Disease

Treatments: Behavioral: assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT06389903

2018-A00185-50

Details and patient eligibility

About

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).

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Behavorial Assessment

Experimental group

Description:

post-surgery behavioral assessment using scales

Treatment:

Behavioral: assessment