Parkinson's DiseaseNCT05034510
Short Pulse Width Versus Low Frequency DBS in Parkinson's Disease
A study testing Deep Brain Stimulation in people with Parkinson's Disease, run by University Hospital of Ferrara at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2021to 20 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- No psychiatric disorders
- All patients will be ≥ 18 years of age
- Documented informed consent
Who cannot join
- no documented informed consent
- axial disorders not related to Parkinson's disease
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University Hospital of Ferrara - Arcispedale Sant'Anna
Ferrara, Emilia-Romagna, 44122
Mariachiara Sensi, PhD, 0039-0532-237540, mc.sensi@ospfe.it
About this study
Official title: 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
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).
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Deep Brain Stimulation
- Keywords
- DBS, Parkinson's disease, low frequency, short pulse width, axial symptoms
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
modification in stimulation parameters
| Study group | Role | What they receive |
|---|---|---|
| Low frequency 80 Hz then short pulse width 30 usec stimulation | Active comparator | 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. Receives: Device: Deep Brain Stimulation |
| Short pulse width 30 usec then low frequency 80 Hz stimulation | Active comparator | 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. Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freezing of gait incidence reduction
change of freezing of gait incidence as measured by Freezing of Gait Questionnaire item-3
Measured: 4 weeks
Improvement of freezing ratio
change in freezing ratio
Measured: 4 weeks
Secondary outcomes (2)
reduction of freezing of gait duration
change of composite measure from item-4, item-5 and item-6 of Freezing of Gait Questionnaire
Measured: 4 weeks
improvement in speech quality
change in Movement Disorder Society UPDRS item 3.1
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start20 Mar 2021
- Primary completion20 Mar 2023 (estimated)
- Study completion20 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariachiara Sensi, PhD, Principal investigator, Azienda Ospedaliero Universitaria di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034510
- Sponsor's protocol ID
- 203/2019/Disp/AOUFe
- Status last verified
- May 2022
- First submitted
- 27 Aug 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05034510
- Acronym / sponsor ID
- 203/2019/Disp/AOUFe
- Conditions
- Parkinson's Disease
- Keywords
- DBS, Parkinson's disease, low frequency, short pulse width, axial symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 20 Mar 2023 (estimated)
- Study completion
- 20 Mar 2024 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low frequency 80 Hz then short pulse width 30 usec stimulation | Active comparator | Device: Deep Brain StimulationEach 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. |
| Short pulse width 30 usec then low frequency 80 Hz stimulation | Active comparator | Device: Deep Brain StimulationEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- no documented informed consent
- axial disorders not related to Parkinson's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain Stimulationmodification in stimulation parameters | Device | Low frequency 80 Hz then short pulse width 30 usec stimulation, Short pulse width 30 usec then low frequency 80 Hz stimulation |
Primary outcome
Freezing of gait incidence reduction
Time frame: 4 weeks
change of freezing of gait incidence as measured by Freezing of Gait Questionnaire item-3
Improvement of freezing ratio
Time frame: 4 weeks
change in freezing ratio
2 secondary outcomes
reduction of freezing of gait duration
Time frame: 4 weeks
improvement in speech quality
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariachiara Sensi, PhD principal investigator
Azienda Ospedaliero Universitaria di Ferrara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Parkinson's Disease, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariachiara Sensi, PhD (0039-0532-237540, mc.sensi@ospfe.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freezing of gait incidence reduction (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.