Parkinson's Disease
Conditions
Keywords
DBS, Parkinson's disease, low frequency, short pulse width, axial symptoms
Brief summary
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
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.
Interventions
DEVICEDeep Brain Stimulation
modification in stimulation parameters
Sponsors
University Hospital of Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freezing of gait incidence reduction | 4 weeks | change of freezing of gait incidence as measured by Freezing of Gait Questionnaire item-3 |
| Improvement of freezing ratio | 4 weeks | change in freezing ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| reduction of freezing of gait duration | 4 weeks | change of composite measure from item-4, item-5 and item-6 of Freezing of Gait Questionnaire |
| improvement in speech quality | 4 weeks | change in Movement Disorder Society UPDRS item 3.1 |
Countries
Italy
Contacts
Primary ContactMariachiara Sensi, PhD
Outcome results
None listed