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

April 25, 2024 updated by: Centre Hospitalier du Rouvray

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Sotteville Les Rouen, France, 76300
        • Marie Desbordes, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavorial Assessment
post-surgery behavioral assessment using scales
Behavioral: assessment
post-surgery behavioral assessment using scales

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 72 hours, 1 month and 3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of change of depressive symptoms
Time Frame: Baseline, 72 hours, 1 month and 3 months after surgery
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
Assessment of change of Behavior
Time Frame: Baseline, 72 hours, 1 month and 3 months after surgery
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
Time Frame: Baseline, 72 hours, 1 month and 3 months after surgery
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
Time Frame: Baseline, 72 hours, 1 month and 3 months after surgery
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
Time Frame: Baseline

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
Assessment of executive functions
Time Frame: Baseline, 72 hours, 3 months after surgery
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
Time Frame: 72 hours and 3 months after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier du Rouvray

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2019

Primary Completion (Actual)

July 3, 2020

Study Completion (Actual)

October 5, 2021

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A00185-50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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