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

NCT ID: NCT06389903

Last Updated: 2024-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-04

Study Completion Date

2021-10-05

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Behavorial Assessment

post-surgery behavioral assessment using scales

Group Type EXPERIMENTAL

assessment

Intervention Type BEHAVIORAL

post-surgery behavioral assessment using scales

Interventions

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assessment

post-surgery behavioral assessment using scales

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier du Rouvray

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Marie Desbordes, MD

Sotteville-lès-Rouen, , France

Site Status

Countries

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France

Other Identifiers

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2018-A00185-50

Identifier Type: -

Identifier Source: org_study_id

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