Short Pulse Width Versus Low Frequency DBS in Parkinson's Disease
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mariachiara Sensi, PhD
- Phone Number: 0039-0532-237540
- Email: mc.sensi@ospfe.it
Study Locations
-
-
Emilia Romagna
-
Ferrara, Emilia Romagna, Italy, 44122
- Recruiting
- University Hospital of Ferrara - Arcispedale Sant'Anna
-
Contact:
- Mariachiara Sensi, PhD
- Phone Number: 0039-0532-237540
- Email: mc.sensi@ospfe.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Low frequency 80 Hz then short pulse width 30 usec stimulation
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.
|
modification in stimulation parameters
|
|
ACTIVE_COMPARATOR: Short pulse width 30 usec then low frequency 80 Hz stimulation
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.
|
modification in stimulation parameters
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Freezing of gait incidence reduction
Time Frame: 4 weeks
|
change of freezing of gait incidence as measured by Freezing of Gait Questionnaire item-3
|
4 weeks
|
|
Improvement of freezing ratio
Time Frame: 4 weeks
|
change in freezing ratio
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
reduction of freezing of gait duration
Time Frame: 4 weeks
|
change of composite measure from item-4, item-5 and item-6 of Freezing of Gait Questionnaire
|
4 weeks
|
|
improvement in speech quality
Time Frame: 4 weeks
|
change in Movement Disorder Society UPDRS item 3.1
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mariachiara Sensi, PhD, Azienda Ospedaliero Universitaria di Ferrara
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 203/2019/Disp/AOUFe
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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