Clinical trial NCT05003206: Predictive Value of Multimodal MRI in Parkinson's Disease
Official title: Multimodal Magnetic Resonance Imaging Studying the Mechanism and Predicting the Outcome After Deep Brain Stimulation in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Magnetic Resonance Imaging
Deep Brain Stimulation
Keywords: Subthalamic nucleus deep brain stimulation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Deep brain stimulation (DBS) is recognized as the most safe and effective neurosurgical method for the treatment of advanced Parkinson's disease. However, the mechanism of relieving motor and non-motor symptoms of Parkinson's disease has not been fully clarified, and the prognosis is significantly different. This study is based on multimodal MRI technique to clarify the mechanism of DBS in relieving motor and non-motor symptoms of Parkinson's disease, and to explore imaging indicators that can predict prognosis, so as to guide the individual and accurate treatment of Parkinson's disease (PD).

Detailed description: 1. Preoperative and postoperative multimodal MRI scanning 1) equipment: 3TGE 750 MRI 2) sequence: resting state fMRI, DTI, 3DTI, ESWAN, ASL 3) scan status: drug shutdown period ( discontinuation of drugs for Parkinson's disease for at least 12 hours), for patients who can not adhere to MRI scanning after drug withdrawal. Record the dosage of drugs before scanning
2. Evaluation of motor and non-motor symptoms: pre-operation and 1-year post-operation 1) motor symptoms: pre-operation medication opening and closing period. Postoperative medication off/stimulation off (Med-OFF/DBS-OFF);Med-ON/DBS-OFF;Med-OFF/DBS-ON;Med-ON/DBS-ON

   1. overall evaluation of motor function: MDS-UPRDS, H\&Y stage
   2. balance: Berg balance scale
   3. dyskinesia: abnormal involuntary movement scale(AIMS)
   4. end-of-dose phenomenon: WOQ19 end-of-dose phenomenon questionnaire
   5. daily activity ability: SCHWAB\&ENGLAND daily activity scale 2) non-motor symptoms: preoperative drug shutdown period. Postoperative drug shutdown / DBS opening

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   1. Cognitive function: Mini Mental State Examination scale (MMSE), Montreal Cognitive Assessment scale (MoCA)
   2. emotion: Hamilton Depression scale (HAMD), Hamilton anxiety scale (HAMA)
   3. Sleep: PD Sleep scale (PDSS), Appleworth sleepiness scale (ESS), REM Sleep Behavioral Disorder questionnaire-Hong Kong (RBDQ-HK)
   4. pain: King Parkinson's disease pain scale (KPPS)
   5. fatigue: fatigue severity scale (FSS)
   6. autonomic nervous function assessment: autonomic nervous scale (SCOPA-AUT) h) quality of life: 39 items Parkinson's disease quality of life questionnaire (PDQ-39) 3.other records: changes in type, dose and mode of use of drugs. Daily equivalent dose of levodopa (tomlinson2010 conversion)

Eligibility criteria: Inclusion Criteria:

* Patient with Parkinson's disease
* age\< 70 years
* Underwent bilateral STN-DBS or not
* Having complete medical history and clinical follow up
* All MRI examination performed according to study protocol
* Imaging data can be processed
* Signed informed consent obtained from the patient or patient's legally authorized representative;

Exclusion Criteria:

* Parkinson-plus syndrome or secondary parkinsonism
* Patients with severe mental disorders such as psychosis, liver and kidney dysfunction, poor blood pressure or blood glucose control, severe depression and substance abuse, low IQ, and acute phase of severe stroke with definite limb dysfunction should also be excluded.

Primary outcomes:
measure: Clinical characteristics of patients
timeFrame: 1 to 2 years
measure: Percentage of improvement in motor aspects (after 12 months of stimulation)
timeFrame: 1 to 3 years
Secondary outcomes:
measure: other records:
timeFrame: 1 to 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Xin Lou
role: STUDY_CHAIR
References: