Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-14
Brief Title:
Study of the Effects of STN-DBS on Gait in Parkinsons Disease
Sponsor:
Fujian Medical University Union Hospital
Organization:
Fujian Medical University Union Hospital
Study Overview
Official Title:
Clinical Series Study of the Effects of STN-DBS on Gait in Parkinsons Disease Based on Wearable Devices
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives Parkinsons disease PD is the second most common degenerative disease of the nervous system Postural instabilitygait disorder PIGD is one of the motor symptoms of Parkinsons disease which affects the quality of life of patients with Parkinsons disease At present deep brain stimulationDBScan 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 Parkinsons disease
Methods A total of 30 patients with Subthalamic nucleus DBSSTN-DBSwere 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 Parkinsons Disease Rating Scale assessmentMDS-UPDRS The Timed Up and GoTUG 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 1Experiment 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 month3 months6 months and 1 year after operation 2Experiment 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 3Experiment 3 By adjusting the frequency parameters of STN-DBS 30100 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
Methods A total of 30 patients with Subthalamic nucleus DBSSTN-DBSwere 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 Parkinsons Disease Rating Scale assessmentMDS-UPDRS The Timed Up and GoTUG 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 1Experiment 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 month3 months6 months and 1 year after operation 2Experiment 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 3Experiment 3 By adjusting the frequency parameters of STN-DBS 30100 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None