Parkinson DiseaseNCT04285099
Frequency Effect of STN-DBS Through the Dual System on FOG in PD
A study testing Application of dual system in frequency A and Application of dual system in frequency B in people with Parkinson Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
We aim to confirm the effect for FOG by changing the frequency through the dual-system approach in PD patients after STN-DBS. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Application of dual system in frequency A and Application of dual system in frequency B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2020to 28 Feb 2021
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with PD who are aged 30 years or older
- patients with bilateral STN-DBS
- patients who have a FOG at their med "off" state in outpatient clinic or hospitalization, or UPDRS part II FOG subscore above 1
Who cannot join
- patients without FOG
- patients who have undergone DBS
- patients who have had previous brain surgery
- patients who have undergone reoperation of DBS
- patients who underwent unilateral DBS
- patients with cognitive impairment (MMSE <18)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frequency Effect of Subthalamic Nucleus Deep Brain Stimulation Through the Dual System on Freezing of Gait in Parkinson Disease
We aim to confirm the effect for FOG by changing the frequency through the dual-system approach in PD patients after STN-DBS.
Read the detailed description
The investigators set two values of frequency (130, 60Hz) in IPG and allow the patients to change the frequencies freely using the patient controller. After four weeks, the investigators will check the UPDRS part I, II, IV, FOG-Q, and PDQ-39 values at each frequency, including the proportion of use of two frequencies.
- Conditions
- Parkinson Disease
- Being tested
- Application of dual system in frequency A, Application of dual system in frequency B
- Keywords
- Parkinson Disease, Freezing of Gait, Deep Brain Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of dual system in frequency ADevice
The investigators set two values of frequency (130, 60Hz) in IPG and allow the patients to change the frequencies freely using the patient controller. Technician randomly sets 130 Hz, 60HZ to A or B.
Application of dual system in frequency BDevice
The investigators set two values of frequency (130, 60Hz) in IPG and allow the patients to change the frequencies freely using the patient controller. Technician randomly sets 130 Hz, 60HZ to A or B.
| Study group | Role | What they receive |
|---|---|---|
| PD patients with FOG after STN-DBS[A] | Experimental | Initially started by A setting Receives: Device: Application of dual system in frequency A |
| PD patients with FOG after STN-DBS[B] | Experimental | Initially started by B setting Receives: Device: Application of dual system in frequency B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulation frequency ratio in 4 weeks
Proportion of two frequencies in 4 weeks
Measured: 4 weeks
Secondary outcomes (5)
Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score in 130 and 60Hz at the fourth week
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score will be used to compare 130Hz with 60Hz. Higher scores mean a worse outcome. [minimum 0, maximum 52]
Measured: 4 weeks
Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score in 130 and 60Hz at the fourth week
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score will be used to compare 130Hz with 60Hz. Higher scores mean a worse outcome. [minimum 0, maximum 52]
Measured: 4 weeks
Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score in 130 and 60Hz at the fourth week
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score will be used to compare 130Hz with 60Hz. Higher scores mean a worse outcome. [minimum 0, maximum 24]
Measured: 4 weeks
Comparison of Freezing of Gait Questionnaire score in 130 and 60Hz at the fourth week
Freezing of Gait Questionnaire score will be used to compare 130Hz with 60Hz. Higher scores mean a worse outcome. [minimum 0, maximum 24]
Measured: 4 weeks
Comparison of Parkinson's Disease Questionnaire-39 score in 130 and 60Hz at the fourth week
Parkinson's Disease Questionnaire-39 score will be used to compare 130Hz with 60Hz. Higher scores mean a worse outcome. [minimum 0, maximum 156]
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 posted26 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion28 Feb 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BS Jeon, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285099
- Sponsor's protocol ID
- H-1902-132-1091
- Status last verified
- Feb 2020
- First submitted
- 24 Feb 2020
- Last updated
- 26 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency Effect of Subthalamic Nucleus Deep Brain Stimulation Through the Dual System on Freezing of Gait in Parkinson Disease
- ClinicalTrials.gov ID
- NCT04285099
- Acronym / sponsor ID
- H-1902-132-1091
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Freezing of Gait, Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 26 Feb 2020 (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.
We aim to confirm the effect for FOG by changing the frequency through the dual-system approach in PD patients after STN-DBS.
Detailed description
The investigators set two values of frequency (130, 60Hz) in IPG and allow the patients to change the frequencies freely using the patient controller. After four weeks, the investigators will check the UPDRS part I, II, IV, FOG-Q, and PDQ-39 values at each frequency, including the proportion of use of two frequencies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD patients with FOG after STN-DBS[A] | Experimental | Device: Application of dual system in frequency AInitially started by A setting |
| PD patients with FOG after STN-DBS[B] | Experimental | Device: Application of dual system in frequency BInitially started by B setting |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with PD who are aged 30 years or older
- patients with bilateral STN-DBS
- patients who have a FOG at their med "off" state in outpatient clinic or hospitalization, or UPDRS part II FOG subscore above 1
Key exclusion criteria (6 listed)
- patients without FOG
- patients who have undergone DBS
- patients who have had previous brain surgery
- patients who have undergone reoperation of DBS
- patients who underwent unilateral DBS
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 |
|---|---|---|
| Application of dual system in frequency AThe investigators set two values of frequency (130, 60Hz) in IPG and allow the patients to change the frequencies freely using the patient controller. Technician randomly sets 130 Hz, 60HZ to A or B. | Device | PD patients with FOG after STN-DBS[A] |
| Application of dual system in frequency BThe investigators set two values of frequency (130, 60Hz) in IPG and allow the patients to change the frequencies freely using the patient controller. Technician randomly sets 130 Hz, 60HZ to A or B. | Device | PD patients with FOG after STN-DBS[B] |
Primary outcome
Stimulation frequency ratio in 4 weeks
Time frame: 4 weeks
Proportion of two frequencies in 4 weeks
5 secondary outcomes
Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score in 130 and 60Hz at the fourth week
Time frame: 4 weeks
Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score in 130 and 60Hz at the fourth week
Time frame: 4 weeks
Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score in 130 and 60Hz at the fourth week
Time frame: 4 weeks
Comparison of Freezing of Gait Questionnaire score in 130 and 60Hz at the fourth week
Time frame: 4 weeks
Comparison of Parkinson's Disease Questionnaire-39 score in 130 and 60Hz at the fourth week
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 26 Feb 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of dual system in frequency A and Application of dual system in frequency B in people with Parkinson Disease, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 6 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 26 Feb 2020. 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 South Korea. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stimulation frequency ratio in 4 weeks (time frame: 4 weeks). 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 26 Feb 2020.