Clinical trial NCT05905198: Programming Strategy of VFS for Gait Impairments in PD
Official title: Programming Strategy of Variable Frequency Stimulation for Gait Impairments in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Deep Brain Stimulation
Gait Disorders, Neurologic
Keywords: Parkinson's disease
Deep brain stimulation
Variable frequency stimulation
Movement disorder
Freezing of gait
Crossover study
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline 5m-Timed Up and Go test Time Result at 2 months.
timeFrame: Baseline, 2 months
measure: Change from Baseline 5m-Timed Up and Go test Time Result at 4 months.
timeFrame: Baseline, 4 months
Secondary outcomes:
measure: Change from Baseline 5m-Timed Up and Go test Step Frequency at 2 months.
timeFrame: Baseline, 2 months
measure: Change from Baseline 5m-Timed Up and Go test Step Frequency at 4 months.
timeFrame: Baseline, 4 months
measure: Change from Baseline 5m-Timed Up and Go test Length at 2 months.
timeFrame: Baseline, 2 months
measure: Change from Baseline 5m-Timed Up and Go test Step Length at 4 months.
timeFrame: Baseline, 4 months
measure: Change from Baseline 5m-Timed Up and Go test Step Variation Coefficient at 2 months.
timeFrame: Baseline, 2 months
measure: Change from Baseline 5m-Timed Up and Go test Step Variation Coefficient at 4 months.
timeFrame: Baseline, 4 months
measure: Change from Baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part III score at 2 months.
timeFrame: Baseline, 2 months
measure: Change from Baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part III score at 4 months.
timeFrame: Baseline, 4 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yi Guo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: