Programming Strategy of VFS for Gait Impairments in PD

Parkinson's Disease Clinical Trial

Official title:

Programming Strategy of Variable Frequency Stimulation for Gait Impairments in Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05905198
• Other study ID #: K3438
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: June 2023
• Source: Peking Union Medical College Hospital
• Contact: Yi Guo, M.D.
• Phone: 13910091280
• Email: guoyi[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Variable Frequency Stimulation(VFS) is a stimulation pattern applied in Deep Brain Stimulation(DBS) therapy for Parkinson's disease(PD). Peking Union Medical College Hospital was the first centre conducting research on VFS. The studies in the past have resembled conclusion that VFS provides improvement not only in the major symptoms such as tremor and rigidity, but also in gait and balance disorder. However, the best programming strategy of VFS has not met agreement. The random-controlled double blinded crossover study is designed for participants who underwent DBS surgery in bilateral subthalamic nucleus for parkinson's disease. The investigators study several strategies on programming and observe the improvement of symptom to look for the best one. A 4-month follow-up is designed to observe a relatively long-term effectiveness of VFS. The study intends to gather more clinical evidence to guide further studies on VFS application.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Idiopathic Parkinson's disease (according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease);
• 18-75 years of age;
• Hoehn & Yahr = 3 (in best OFF-medication condition);
• Implanted bilateral subthalamic nucleus DBS for over 1 year;
• gait Impairments in OFF-medication condition;
• High Frequency Stimulation provides significant improvement;
• in OFF-medication On-stimulation condition, capable of walking = 10m.

Exclusion Criteria:

• mental disorder or dementia;
• Pregnant women, lactating mothers or women who are unable to take effective measures to prevent pregnancy;
• With other diseases that can affect walking distance, such as joint diseases of the lower body, spinal diseases, neuropathy, or serious heart or lung diseases;
• In severe health condition, such as diseases associated with heart or liver;
• Epilepsy;
• Lead off target;
• Unable to willingly sign Written informed Consent;
• Disagree or unable to cooperate with follow-up sessions.

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Gait Disorders, Neurologic
• Nervous System Diseases
• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Programming
programming the implanted DBS device to adjust the parameter and switch stimulation mode between Variable-Frequency settings and High-Frequency settings.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline 5m-Timed Up and Go test Time Result at 2 months.	Conduct a TUG test with 5m range setting and measure the time cost	Baseline, 2 months
Primary	Change from Baseline 5m-Timed Up and Go test Time Result at 4 months.	Conduct a TUG test with 5m range setting and measure the time cost	Baseline, 4 months
Secondary	Change from Baseline 5m-Timed Up and Go test Step Frequency at 2 months.	Conduct a TUG test with 5m range setting and measure the step movement and calculate the step frequency	Baseline, 2 months
Secondary	Change from Baseline 5m-Timed Up and Go test Step Frequency at 4 months.	Conduct a TUG test with 5m range setting and measure the step movement and calculate the step frequency	Baseline, 4 months
Secondary	Change from Baseline 5m-Timed Up and Go test Length at 2 months.	Conduct a TUG test with 5m range setting and measure the length of each step	Baseline, 2 months
Secondary	Change from Baseline 5m-Timed Up and Go test Step Length at 4 months.	Conduct a TUG test with 5m range setting and measure the length of each step	Baseline, 4 months
Secondary	Change from Baseline 5m-Timed Up and Go test Step Variation Coefficient at 2 months.	Conduct a TUG test with 5m range setting and use the length of each step to calculate the difference coefficient	Baseline, 2 months
Secondary	Change from Baseline 5m-Timed Up and Go test Step Variation Coefficient at 4 months.	Conduct a TUG test with 5m range setting and use the length of each step to calculate the difference coefficient	Baseline, 4 months
Secondary	Change from Baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part III score at 2 months.	Conduct a Movement Disorder Society Unified Parkinson's Disease Rating Scale survey and record the score. Higher MDS UPDRS III score represents worse movement disorder symptoms.	Baseline, 2 months
Secondary	Change from Baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part III score at 4 months.	Conduct a Movement Disorder Society Unified Parkinson's Disease Rating Scale survey and record the score. Higher MDS UPDRS III score represents worse movement disorder symptoms.	Baseline, 4 months