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Completed

NCT Number: NCT02360683

Predictive Factors and Subthalamic Stimulation in Parkinson's Disease

This study identify preoperative predictors of response to subthalamic stimulation at 1 year, 3 years and 5 years in terms of quality of life, from a broad prospective multicenter study French with standardized collection of clinical data , imaging and genetic .

The investigators want to identify factors that predict the improvement of quality of life for one year corresponding to a decrease of PDQ39 score of at least 20 %. They believe that improvement would be less likely to become zero to 3 or 5 years and question the indication of the subthalamic stimulation (risks and costs). This is part of a process of "personalization" of the therapeutic care that is of any interest to the subthalamic stimulation. It is a therapeutic option that could be dangerous if patient selection is not optimal , and expensive, if the benefit is not large enough to reduce the number of medications and hospitalizations medium term . In addition, it will quantify the improvement of quality of life in the longer term and harmonize national assessments .

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Hôpital NORD, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients receiving a pre- therapeutic assessment and therapeutic monitoring for one year , 3 years and 5 years as part of the regular monitoring of the subthalamic stimulation
  • Bilateral STN stimulation considered
  • Patient able to provide their free and informed consent
  • Patient with insurance coverage

Exclusion criteria

  • Atypical Parkinson's disease do not meet the criteria of stuff .
  • MP under 5 years
  • Severe cognitive impairment or dementia ( Score Moca <24 and DSM-IV criteria)
  • Parkinson's Psychosis
  • Reply to L- dopa <30 %
  • Against indication for surgery
  • Severe brain atrophy or abnormal MRI
  • The presence of another very serious condition terminal life- short-term prognosis ( malignancy ) is an indication against .

Treatment and study plan

patients with Parkinson's disease

Other

Other names: systematic and standardized collection of data

Primary outcomes

  1. Improve of quality of life on PDQ39>20%

    Time frame: 1 year

Secondary outcomes

  1. Percentage of motor score MDS-UPDRS III improve under stimulation

    Time frame: 1 year

  2. Socio-familial evolution (institutionalization)

    Time frame: 1, 3 and 5 years

  3. Clinical Global Impression of Patient by 7-point scale

    Time frame: 1, 3 and 5 years

    with the CGI-scale

  4. Clinical Global Impression of doctor by 7-point scale

    Time frame: 1, 3 and 5 years

    with the CGI-scale

  5. Death

    Time frame: 1, 3 and 5 years

  6. Cognitive function with a neuropsychological examination

    Time frame: 1, 3 and 5 years

    with Mattis scale, Wisconsin Card Sorting test, Stroop test, , verbal episodic memory test with 16 items, phonemic and semantic verbal fluency, Boston naming test (15 items), clock drawing and Benton line orientation task

  7. Behavior test

    Time frame: 1, 3 and 5 years

    ECMP scale of Ardouin 2009, Hamilton depression scale, Anxiety Hamilton scale, Lille Apathy Rating Scale, QUIP questionnaire, Billieux Impulsivity Scale, Hallucination questionnaire of Miami

  8. Motor response rates to Levodopa

    Time frame: 1, 3 and 5 years

    with the difference of the motor handicap measured by MDS UPDRS part III before and after an acute L-dopa challenge

  9. Non-motor functions evaluated by a numerical evaluation scale

    Time frame: screening and at 1, 3 and 5 years

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Predictive Factors for Therapeutic Response of Subthalamic Stimulation on Quality of Live in Parkinson's Disease

Acronym: PREDI-STIM

Important dates

Study start
2013
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2015
Registry last updated
Apr 22, 2026

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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