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NCT Number: NCT06389903

Subthalamic Nucleus Stimulation Electrode and Psychiatric Lesion Effects in 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).

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marie Desbordes, MD

Sotteville-lès-Rouen, 76300, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment

Behavioral

post-surgery behavioral assessment using scales

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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)

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier du Rouvray

Other Gov

Registry information

Official study 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.

Acronym: PSYLES-STIM

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 29, 2024
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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