Clinical trial NCT03230331: Follow Up Study for Treatment of Parkinson's Disease With Subthalamic Deep Brain Stimulation
Official title: Long Term Study of Subthalamic Deep Brain Stimulation for Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's Disease who underwent STN DBS for above 10 years or Patients with Parkinson's Disease whose disease duration longer than 15 years.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changs in the score of Stand-Walk-Sit Test
timeFrame: above 10 years post surgery
Secondary outcomes:
measure: Change of the score in United Parkinson Disease Rating Scale (UPDRS) part III
timeFrame: above 10 years post surgery
measure: UPDRS part I score
timeFrame: above 10 years post surgery
measure: UPDRS part II score
timeFrame: above 10 years post surgery
measure: UPDRS part IV score
timeFrame: above 10 years post surgery
measure: 39-Item Parkinson´s Disease Questionnaire (PDQ-39) score
timeFrame: above 10 years post surgery
measure: Freezing of Gait Questionnaire (FOG-Q) score
timeFrame: above 10 years post surgery
measure: Gait and Falls Questionnaire (GFQ) score
timeFrame: above 10 years post surgery
measure: Mini-Mental State Examination (MMSE) score
timeFrame: above 10 years post surgery
measure: Montreal Cognitive Assessment (MoCA) Beijing score Version
timeFrame: above 10 years post surgery
measure: Frontal Assessment Battery (FAB) score
timeFrame: above 10 years post surgery
measure: Hamilton Anxiety Scale (HAMA) score
timeFrame: above 10 years post surgery
measure: Hamilton Depression Scale-17 (HAMD-17) score
timeFrame: above 10 years post surgery
measure: Apathy Evaluation Scale score
timeFrame: above 10 years post surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
name: Haiyan Zhou
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
name: Dianyou Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
name: Bomin Sun
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Wei Hu
role: PRINCIPAL_INVESTIGATOR
References: