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NCT Number: NCT03230331

Follow Up Study for Treatment of Parkinson's Disease With Subthalamic Deep Brain Stimulation

This study aims to evaluate the long term effect of deep brain stimulation in the the subthalamic nucleus (STN) in patients with Parkinson's disease.

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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–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Who can participate

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

Inclusion criteria

  • Idiopathic Parkinson's disease
  • Disease duration longer than 15 years
  • Had STN deep brain stimulation implant more than 10 years
  • Available and willing to be followed-up according to study protocol

Exclusion criteria

  • Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials
  • Epilepsy
  • Pregnant female
  • History of severe neuropsychiatric disease
  • Patients are taking part in other clinical trials in recent several months

Treatment and study plan

Primary outcomes

  1. Changs in the score of Stand-Walk-Sit Test

    Time frame: above 10 years post surgery

Secondary outcomes

  1. Change of the score in United Parkinson Disease Rating Scale (UPDRS) part III

    Time frame: above 10 years post surgery

  2. UPDRS part I score

    Time frame: above 10 years post surgery

  3. UPDRS part II score

    Time frame: above 10 years post surgery

  4. UPDRS part IV score

    Time frame: above 10 years post surgery

  5. 39-Item Parkinson´s Disease Questionnaire (PDQ-39) score

    Time frame: above 10 years post surgery

  6. Freezing of Gait Questionnaire (FOG-Q) score

    Time frame: above 10 years post surgery

  7. Gait and Falls Questionnaire (GFQ) score

    Time frame: above 10 years post surgery

  8. Mini-Mental State Examination (MMSE) score

    Time frame: above 10 years post surgery

  9. Montreal Cognitive Assessment (MoCA) Beijing score Version

    Time frame: above 10 years post surgery

  10. Frontal Assessment Battery (FAB) score

    Time frame: above 10 years post surgery

  11. Hamilton Anxiety Scale (HAMA) score

    Time frame: above 10 years post surgery

  12. Hamilton Depression Scale-17 (HAMD-17) score

    Time frame: above 10 years post surgery

  13. Apathy Evaluation Scale score

    Time frame: above 10 years post surgery

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Long Term Study of Subthalamic Deep Brain Stimulation for Parkinson's Disease

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2017
Registry last updated
Mar 11, 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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