Programming Strategy of VFS for Gait Impairments in PD

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Gait Disorders, Neurologic; Parkinson's Disease; Deep Brain Stimulation

Treatments: Device: Programming

Study type: Interventional

Funder types: Other

Identifiers

NCT05905198

K3438

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

HFS-VFS

Experimental group

Description:

This arm will experience HFS first during the crossover, and then VFS.

Treatment:

Device: Programming

VFS-HFS

Experimental group

Description:

This arm will experience VFS first during the crossover, and then HFS.

Treatment:

Device: Programming