NCT06418802

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

Clinical Series Study of the Effects of STN-DBS on Gait in Parkinson's Disease Based on Wearable Devices.
Fujian Medical University Union Hospital·ClinicalTrials.gov·procedureNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Parkinson Disease
Drug/Device/Intervention
STN-DBS surgery
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Fujian Medical University Union Hospital
Timeline & enrollment
Phase
N/A
Start date
Jun 01, 2024
End date
Mar 01, 2026
Enrollment
30 participants
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
Parkinson diseaseParkinsonism in diseases classified elsewhereDementia in Parkinson diseaseSecondary parkinsonismSecondary parkinsonism, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06418802
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06418802 through Pure Global AI's free database. This phase not specified trial is sponsored by Fujian Medical University Union Hospital and is currently Not yet recruiting. The study focuses on Parkinson Disease. Target enrollment is 30 participants.

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