Study of the Effects of STN-DBS on Gait in Parkinson's Disease. - Trial NCT06418802

Timeline & Enrollment

Primary Outcome

Gait data,Gait data,Gait data

Summary

Objectives: Parkinson's disease (PD) is the second most common degenerative disease of the
 nervous system. Postural instability/gait disorder (PIGD) is one of the motor symptoms of
 Parkinson's disease, which affects the quality of life of patients with Parkinson's disease.
 At present, deep brain stimulation（DBS）can significantly improve tremor and bradykinesia, but
 whether deep brain stimulation is effective for gait disorders is still a controversial
 topic. In addition, the previous gait assessment mainly focused on scales or simple walking
 tests, and appropriate and effective evaluation methods are needed to evaluate the efficacy
 of intervention for gait disorders in PD patients. Therefore, in view of these problems, this
 study will use wearable devices and traditional scale evaluation to explore the effects of
 deep brain stimulation on gait in patients with Parkinson's disease.
 
 Methods: A total of 30 patients with Subthalamic nucleus DBS（STN-DBS）were expected to be
 enrolled. By adjusting the parameters of STN-DBS (voltage, frequency, pulse width), the
 effects of different parameters on PD gait were compared. Gait changes were mainly analyzed
 by wearable devices and MDS Unified Parkinson's Disease Rating Scale assessment（MDS-UPDRS）.
 The （Timed Up and Go）TUG test, narrow channel task, circle task and trajectory analysis were
 performed in the unmedicated state. The wearable device was used to collect the motion
 information of 10 different positions of the human body, including the wrist, thigh, ankle,
 foot tip, chest and waist nodes. (1)Experiment 1: Patients were divided into pre-operation
 group and post-operation group. A case-control study was conducted, and patients were
 followed up at 1 month,3 months,6 months and 1 year after operation. (2)Experiment 2: This
 study was a single-center, randomized, double-blind, crossover trial of deep brain
 stimulation with a short pulse width (30s) versus conventional pulse width (60 s) in PD
 patients with bilateral STN-DBS. Gait data and MDS-UPDRS were collected at baseline, after 4
 weeks and 8 weeks. (3)Experiment 3: By adjusting the frequency parameters of STN-DBS (30,100,
 and 130HZ), gait data and MDS-UPDRS were collected after 10 minutes of the washout period,
 and the best DBS parameters for gait improvement were maintained for 4-8 weeks and then
 evaluated again.
 
 Expected results: By adjusting the parameters (voltage, frequency, and pulse width) of
 STN-DBS, the potential mechanisms for improving gait disorders in PD were explored,
 meaningful digital biomarkers for PD gait prognosis were explored, and long-term programming
 of STN-DBS was guided.

ICD-10 Classifications