An interventional study of Functional magnetic resonance imaging and Deep Brain Stimulation in Parkinson's Disease, Magnetic Resonance Imaging and Deep Brain Stimulation, sponsored by Chinese PLA General Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2021-08-12.
Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Basic science
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).
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
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4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.
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Exclusion Criteria:
Patients with idiopathic PD before and after DBS surgery
Other: Functional magnetic resonance imaging · Device: Deep Brain Stimulation
Preoperative and postoperative functional magnetic resonance imaging (fMRI) scanning. fMRI is a new neuroimaging method. Its principle is to use magnetic resonance imaging to measure the changes of hemodynamics caused by neuronal activity.
For PD patients treated with DBS, the neurologist will turn off the stimulator before MRI scan
Clinical characteristics of patients
Age at onset; age at surgery; disease duration; level of education; comorbidities (e.g. hypertension and diabetes mellitus); parkinsonism subtype; period of motor fluctuations; time from motor fluctuations to surgery; cigarette smoking
Time frame: 1 to 2 years
Percentage of improvement in motor aspects (after 12 months of stimulation)
(UPDRS III 12 months - UPDRS III baseline)/UPDRS III baseline where UPDRS III 12 months means the score of this test in "medication off , stimulation on" condition at 12 months after implant, while UPDRS III baseline means the score of this test in "medication off " condition.The clinical outcome, or degree of symptom benefit, was defined as a ≥50% improvement on a disease severity rating scale
Time frame: 1 to 3 years
other records:
Changes in type, dose and mode of use of drugs. Daily equivalent dose of levodopa (tomlinson2010 conversion)
Time frame: 1 to 3 years
Plan to share: No
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Chinese PLA General Hospital