The study is an open-label, prospective, single-arm, unicentral (Huashan Hospital Department of Neurology/ Neurosurgery) and exploratory clinical trial. Subjects will be enrolled from Parkinson's disease and Movement Disorder specialized outpatient department of Neurology in Huashan Hospital and network platform of chronic diseases. Spinal Cord Stimultion (SCS) will be performed in department of Neurosurgery and cerebral metabolism will be assessed in PET center of Huashan Hospital. Specialists in Neurology will follow up 3 months to record any unsafe incidents of progressive supranuclear palsy patients after the SCS surgery to evaluate safety. Meanwhile, improvement in gait disorder (including 10MWT and TUG test score) will be measured to evaluate efficacy.
The Study to Evaluate the Safety and Efficacy of Spinal Cord Stimulation on Progressive Supranuclear Palsy is an open-label, prospective, single-arm, unicentral and exploratory clinical trial. In the screening stage, patients clinically and radiologically diagnosed as progressive supranuclear palsy with prominent gait disturbance will be enrolled. Then comprehensive evaluations and spinal cord stimulation will be performed on patients eligible for stimulation. In the subsequent process of neuromodulation, changes of clinical presentations and cerebral metabolism of participants will be assessed. Any unsafe incidents in process will be recorded in detail.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Spinal cord stimulation is a treatment that implants a electrode in posterior epidural space of patient's spinal canal to send mild electric current to stimulate conducting bundle of the posterior column of the spinal cord and posterior horn sensory neurons.
Huashan Hospital
Shanghai, Shanghai Municipality, China
Safety of Spinal Cord Stimulation
Safety evaluation will be performed 3 months after Spinal Cord Stimualtion
Time frame: 3 months
Efficacy of Spinal Cord Stimulation on walk gait.
The change of 10 Meter Walk Test (10MWT) scores. The 10MWT recorded the time to finish the test, and the maximum time is 5 minutes. The longer time suggest more severe condition.
Time frame: 3 months after Spinal Cord Stimualtion.
Efficacy of Spinal Cord Stimulation on walk time.
Changes of the Time Up \& Go (TUG) test score. TUG test recorded the time to finish the test, the minimum time is 0 and the maximum time is 5 minutes. The longer time suggest more severe condition.
Time frame: 3 months after Spinal Cord Stimualtion.
Alteration of cerebral metabolism in 18F-FDG-PET imaging
Alteration of cerebral metabolism in 18F-FDG-PET imaging 6 months after Spinal Cord Stimualtion
Time frame: 6 months
Alteration of gait, balance and motor score
Alteration of gait, balance and motor score 1 month, 6 months after Spinal Cord Stimualtion. The New Freezing of Gait Questionnaire (NFOG-Q) will be assessed, with the minimum score to be 0 and the maximum score to be 30 scores, with higher scores suggest more severe condition.
Time frame: 1 month, 6 months
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