Parkinson DiseaseNCT03230331
Follow Up Study for Treatment of Parkinson's Disease With Subthalamic Deep Brain Stimulation
An observational study of Parkinson Disease, run by Ruijin Hospital at 1 site in China.
Trial summary
This study aims to evaluate the long term effect of deep brain stimulation in the the subthalamic nucleus (STN) in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2017to 1 May 2019
- Phase
- Observational
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients with Parkinson's Disease who underwent STN DBS for above 10 years or Patients with Parkinson's Disease whose disease duration longer than 15 years.
Who may be able to join
- Idiopathic Parkinson's disease
- Disease duration longer than 15 years
- Had STN deep brain stimulation implant more than 10 years
- Available and willing to be followed-up according to study protocol
Who cannot join
- Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials
- Epilepsy
- Pregnant female
- History of severe neuropsychiatric disease
- Patients are taking part in other clinical trials in recent several months
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
Official title: Long Term Study of Subthalamic Deep Brain Stimulation for Parkinson's Disease
This study aims to evaluate the long term effect of deep brain stimulation in the the subthalamic nucleus (STN) in patients with Parkinson's disease.
- Conditions
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| STN DBS | Parkinson's disease (PD) patients who underwent deep brain stimulation (DBS) of the subthalamic nucleus (STN) | |
| CONTROL | Parkinson's disease (PD) patients received optimized medical treatment according to published evidence based guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changs in the score of Stand-Walk-Sit Test
Measured: above 10 years post surgery
Secondary outcomes (13)
Change of the score in United Parkinson Disease Rating Scale (UPDRS) part III
Measured: above 10 years post surgery
UPDRS part I score
Measured: above 10 years post surgery
UPDRS part II score
Measured: above 10 years post surgery
UPDRS part IV score
Measured: above 10 years post surgery
39-Item Parkinson´s Disease Questionnaire (PDQ-39) score
Measured: above 10 years post surgery
Freezing of Gait Questionnaire (FOG-Q) score
Measured: above 10 years post surgery
Gait and Falls Questionnaire (GFQ) score
Measured: above 10 years post surgery
Mini-Mental State Examination (MMSE) score
Measured: above 10 years post surgery
Montreal Cognitive Assessment (MoCA) Beijing score Version
Measured: above 10 years post surgery
Frontal Assessment Battery (FAB) score
Measured: above 10 years post surgery
Hamilton Anxiety Scale (HAMA) score
Measured: above 10 years post surgery
Hamilton Depression Scale-17 (HAMD-17) score
Measured: above 10 years post surgery
Apathy Evaluation Scale score
Measured: above 10 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start24 Jul 2017
- Primary completion1 May 2019
- Study completion1 May 2019
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 Ruijin 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiyan Zhou, Ruijin Hospital
- Investigators
- Haiyan Zhou, Principal investigator, Ruijin HospitalDianyou Li, Principal investigator, Ruijin HospitalBomin Sun, Principal investigator, Ruijin HospitalWei Hu, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230331
- Sponsor's protocol ID
- FOGSTN
- Status last verified
- Mar 2020
- First submitted
- 24 Jul 2017
- Last updated
- 11 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Study of Subthalamic Deep Brain Stimulation for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03230331
- Acronym / sponsor ID
- FOGSTN
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 26 Jul 2017 (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.
This study aims to evaluate the long term effect of deep brain stimulation in the the subthalamic nucleus (STN) in patients with Parkinson's disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STN DBS | – | –Parkinson's disease (PD) patients who underwent deep brain stimulation (DBS) of the subthalamic nucleus (STN) |
| CONTROL | – | –Parkinson's disease (PD) patients received optimized medical treatment according to published evidence based guidelines |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's Disease who underwent STN DBS for above 10 years or Patients with Parkinson's Disease whose disease duration longer than 15 years.
Key inclusion criteria (4 listed)
- Idiopathic Parkinson's disease
- Disease duration longer than 15 years
- Had STN deep brain stimulation implant more than 10 years
- Available and willing to be followed-up according to study protocol
Key exclusion criteria (5 listed)
- Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials
- Epilepsy
- Pregnant female
- History of severe neuropsychiatric disease
- Patients are taking part in other clinical trials in recent several months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changs in the score of Stand-Walk-Sit Test
Time frame: above 10 years post surgery
13 secondary outcomes
Change of the score in United Parkinson Disease Rating Scale (UPDRS) part III
Time frame: above 10 years post surgery
UPDRS part I score
Time frame: above 10 years post surgery
UPDRS part II score
Time frame: above 10 years post surgery
UPDRS part IV score
Time frame: above 10 years post surgery
39-Item Parkinson´s Disease Questionnaire (PDQ-39) score
Time frame: above 10 years post surgery
Freezing of Gait Questionnaire (FOG-Q) score
Time frame: above 10 years post surgery
Gait and Falls Questionnaire (GFQ) score
Time frame: above 10 years post surgery
Mini-Mental State Examination (MMSE) score
Time frame: above 10 years post surgery
Montreal Cognitive Assessment (MoCA) Beijing score Version
Time frame: above 10 years post surgery
Frontal Assessment Battery (FAB) score
Time frame: above 10 years post surgery
Hamilton Anxiety Scale (HAMA) score
Time frame: above 10 years post surgery
Hamilton Depression Scale-17 (HAMD-17) score
Time frame: above 10 years post surgery
Apathy Evaluation Scale score
Time frame: above 10 years post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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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.
Haiyan Zhou principal investigator
Ruijin Hospital
Dianyou Li principal investigator
Ruijin Hospital
Bomin Sun principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Ruijin Hospital at 1 site in China.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 11 Mar 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changs in the score of Stand-Walk-Sit Test (time frame: above 10 years post surgery). 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 11 Mar 2020.