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Completed

NCT Number: NCT04608123

Effect of Deep Brain Stimulation on Neuropsychiatric Fluctuations in Patients With Parkinson's Disease

Retrospective, monocentric, observational study designed to evaluate the effects of Bilateral Subthalamic Nucleus Deep Brain Stimulation (DBS STN) on Neuropsychiatric fluctuations in Patients with Parkinson's Disease (PD)

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Key information

Conditions

Parkinson's Disease (Disorder) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Grenoble

Grenoble, Isère, 38000, France

About this study

Pre-operative versus 12-Month Follow-Up analysis of changing in Neuropsychiatric Fluctuations Scale (NFS) score in preoperative versus postoperative MED OFF (during acute withdrawal of dopaminergic therapy) and MED ON (during super-liminal Levodopa dose) conditions. Postoperative evaluations are always performed with DBS turned on and stimulating (STIM ON)

Who can participate

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

Inclusion criteria

  • Parkinson's disease
  • Treatment with Bilateral STN DBS
  • Evaluation with NFS in both preoperative and 12 months post-surgery follow-up context

Exclusion criteria

  • DBS for non PD patients
  • Unilateral DBS or other DBS targets
  • Patients not evaluated with NFS
  • Patients with incomplete preoperative evaluation
  • Patients who refused the use of their data

Treatment and study plan

None (Observational study)

Other

DBS

Primary outcomes

  1. Effectiveness of DBS for Neuropsychiatric Fluctuations

    Time frame: 12 months after surgery

    Improvement of Neuropsychiatric Fluctuation Scale (NFS) Score between preoperative MED ON and MED OFF conditions versus postoperative MED ON-STIM ON and MED OFF-STIM ON conditions. NFS ON and OFF med scores are independent and they ranges from -30 to +30. Positive scores represent good outcomes (good feelings, non OFF neuropsychiatric symptoms), whereas negative scores denote the presence of negative feelings in a quantity exceeding the positive ones

Secondary outcomes

  1. Preoperative and Postoperative demographical and clinical factors linked to a post-surgical change in Neuropsychiatric Fluctuations

    Time frame: 12 months

    Changing in pre-post op NFS scores correlated with:

    • Demographic and Clinical data: age, sex, disease duration, side onset, clinical phenotype, years passed with fluctuations, comorbidities, psychiatric history not linked to the disease or its treatment, psychiatric complications of dopaminergic therapy
    • Dopaminergic treatment data: years of therapy with Levodopa, percentage of motor improvement with Levodopa-test, pre and postoperative LEDD, changing in psychiatric treatment (doses and number of medications)
    • Perioperative variables: type of anaesthesia, perioperative complications
    • DBS parameters: stimulation type, plots selected, amplitude, rate, duration of impulse, stereo tactical coordinates of electrodes, stimulator type (rechargeable, not rechargeable)

  2. Neuropsychiatric Fluctuations, Cognitive and Psychiatric state

    Time frame: 12 months

    Changing in pre-postop NFS scores correlated with:

    • Cognitive evaluation scales (Mattis Scale, Score Frontal, Wisconsin Card Sorting Test - WCST, Luria manual sequencing task)
    • Psychiatric evaluation scales (Beck Depression Scale - BDI-II, Evaluation Comportamentale dans la Maladie de Parkinson - ECMP, Starkstein Apathy Scale)

  3. Neuropsychiatric Fluctuations, preoperative and postoperative motor status

    Time frame: 12 months

    Changing in pre-postop NFS scores correlated with:

    • Preoperative UPDRS III Score (total score, sub scores of tremor, rigidity, akinesia, parole, posture-gait-instability) in MED ON and MED OFF conditions
    • Changing in UPDRS III Scores (total and sub scores) in preoperative MED ON and MED OFF conditions versus postoperative MED ON STIM ON and MED OFF STIM ON conditions

  4. Neuropsychiatric Fluctuations and other Nonmotor Symptoms

    Time frame: 12 months

    Changing in pre-postop NFS scores correlated with:

    • Changing in MDS-UPDRS scores and sub scores (total, section I, section II, section IV)

  5. Neuropsychiatric Fluctuations and Dopaminergic Therapy

    Time frame: 12 Months

    Changing in pre-postop NFS scores correlated with:

    • Preoperative versus postoperative Levodopa equivalent dose (LEDD)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Effect of Bilateral Subthalamic Nucleus Deep Brain Stimulation on Neuropsychiatric Fluctuations in Patients With Parkinson's Disease, Evaluated With a New, Dedicated Scale

Acronym: PSYCHOSTIM

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 29, 2020
Registry last updated
Nov 2, 2020

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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