Short Pulse Width Versus Low Frequency DBS in Parkinson's Disease

Study Overview
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Brief Summary
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The aim is to compare the effect of reducing the conventional pulse width or frequency of stimulation for axial symptoms occurring after Subthalamic nucleus Deep Brain Stimulation (STN DBS) treatment. The participants will be assessed with chronic stimulation with conventional stimulation parameters, namely 60 us and 130 Hz, and after random allocation to short pulse width (30 us) or low frequency (80 Hz).

Detailed Description
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STN-DBS implanted patient frequently develop axial symptoms, such as gait and speech disorders, after this surgical procedure, which dampens long-term quality of life of Parkinson's disease patients. The pathogenesis is not completely understood, as it could be either due to a long-term stimulation side effect or a symptom with later onset in disease progression which is not well controlled with actual stimulation program. In case of freezing of gait onset in STN-DBS, literature suggest reducing stimulation frequency. Although, low pulse width is a promising option to tackle speech disorders after STN implant, it is not known its potential therapeutic potential on freezing of gait. The aim of this investigation is to compare the effect of low frequency and short pulse width stimulation in patients, who develop axial symptoms during long-term follow-up in chronic conventional STN DBS. As per protocol, participants will be assessed at baseline with chronic standard stimulation parameters (60 us and 130 Hz) then they will be randomly allocated either to a low-frequency (80Hz) or a low-pulse arm (30 us). The study is designed such that after scheduled re-assessment the participant will be switched from low frequency arm to short pulse width and vice versa according to the crossover nature of protocol design. Both the rating investigator and the participant are blinded to the allocation, whereas an unblinded investigator will modify the parameters according to allocation arm.

Official Title
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A Double-Blind Randomized Crossover Comparison Of Short Pulse Width Versus Low Frequency For Axial Symptoms In Subthalamic Nucleus Deep Brain Stimulation (DBS)-Implanted Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: Deep Brain Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Parkinson's disease Subthalamic Nucleus Deep Brain Stimulation with chronic conventional stimulation at 60 usec and 130 Hz for at least 3 months Movement Disorder Society UPDRS part III 3.11 >1 Freezing of Gait Questionnaire item-3 >1 Movement Disorder Society UPDRS part III 3.1 >1 Montreal Cognitive Assessment > 26 No psychiatric disorders All patients will be ≥ 18 years of age Documented informed consent Exclusion Criteria: no documented informed consent axial disorders not related to Parkinson's disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low frequency 80 Hz then short pulse width 30 usec stimulation<br>Each participant will undergo to low frequency stimulation for 4 weeks, then will switch to short pulse width stimulation paradigm for 4 weeks according to the crossover design. | Device: Deep Brain Stimulation<br>* modification in stimulation parameters<br>|
| Active Comparator: Short pulse width 30 usec then low frequency 80 Hz stimulation<br>Each participant will undergo to short pulse width stimulation paradigm for 4 weeks, then will switch to low frequency for 4 weeks according to the crossover design. | Device: Deep Brain Stimulation<br>* modification in stimulation parameters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freezing of gait incidence reduction | change of freezing of gait incidence as measured by Freezing of Gait Questionnaire item-3 | 4 weeks | 
| Improvement of freezing ratio | change in freezing ratio | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of freezing of gait duration | change of composite measure from item-4, item-5 and item-6 of Freezing of Gait Questionnaire | 4 weeks | 
| improvement in speech quality | change in Movement Disorder Society UPDRS item 3.1 | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DBS, Parkinson's disease, low frequency, short pulse width, axial symptoms