Parkinson DiseaseNCT01696812
Web-based International Multi-Center Clinical Study for Parkinson's Disease
A study testing electrode position in people with Parkinson Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The objectives of this study are (1) to compare the clinical outcome in correlation with the electrode positions estimated by web-based image fusion of the preoperative MRI and the postoperative brain CT taken at a stable period after surgery using mutual information technique in the patients with advanced Parkinson's… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- electrode position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to Dec 2020
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced Parkinson Disease patients
Who cannot join
- The patients who have experienced any perioperative or postoperative complications
- The patients with severe cognitive impairment, ongoing psychiatric problems, an unsatisfactory general condition for evaluation, or an inability
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Neurosurgery, Seoul National University Hospital
Seoul, Seoul, 110-744
Sun Ha Paek, M.D., Ph.D., 82-2-2072-3993, paeksh@snu.ac.kr
Sun Ha Paek, M.D., Ph.D.
About this study
Official title: Web-based International Multi-Center Clinical Study for Parkinson's Disease; the Evaluation of Clinical Outcome Based on the Electrode Position Estimated From the Fused Images of Preoperative MRI and Postoperative CT After Bilateral STN DBS
The objectives of this study are (1) to compare the clinical outcome in correlation with the electrode positions estimated by web-based image fusion of the preoperative MRI and the postoperative brain CT taken at a stable period after surgery using mutual information technique in the patients with advanced Parkinson's disease (PD) after bilateral STN DBS and (2) to examine whether the documentation of the electrode position by using mutual information technique at a stable period after unilateral or bilateral STN stimulation provides useful information for the postoperative programming.
- Conditions
- Parkinson Disease
- Being tested
- electrode position
- Keywords
- electrodeposition, Subthalamic Nucleus, Deep Brain Stimulation, 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.
electrode positionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| electrode position, STN DBS, Parkinson' disease | Experimental | To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT via web-site. Receives: Procedure: electrode position |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT
Measured: at 1 month after surgery
Secondary outcomes (1)
UPDRS, H&Y, ADL scores, LEDD
Measured: at 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startNov 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2020 (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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sun Ha Paek, M.D., Ph.D., Principal investigator, Department of Neurosurgery, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696812
- Sponsor's protocol ID
- DELAS-201209
- Other IDs
- DELAS
- Status last verified
- Nov 2014
- First submitted
- 18 Sep 2012
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based International Multi-Center Clinical Study for Parkinson's Disease; the Evaluation of Clinical Outcome Based on the Electrode Position Estimated From the Fused Images of Preoperative MRI and Postoperative CT After Bilateral STN DBS
- ClinicalTrials.gov ID
- NCT01696812
- Acronym / sponsor ID
- DELAS-201209
- Conditions
- Parkinson Disease
- Keywords
- electrodeposition, Subthalamic Nucleus, Deep Brain Stimulation, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 Oct 2012 (estimated)
- 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 objectives of this study are (1) to compare the clinical outcome in correlation with the electrode positions estimated by web-based image fusion of the preoperative MRI and the postoperative brain CT taken at a stable period after surgery using mutual information technique in the patients with advanced Parkinson's disease (PD) after bilateral STN DBS and (2) to examine whether the documentation of the electrode position by using mutual information technique at a stable period after unilateral or bilateral STN stimulation provides useful information for the postoperative programming.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| electrode position, STN DBS, Parkinson' disease | Experimental | Procedure: electrode positionTo determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT via web-site. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Advanced Parkinson Disease patients
Key exclusion criteria (2 listed)
- The patients who have experienced any perioperative or postoperative complications
- The patients with severe cognitive impairment, ongoing psychiatric problems, an unsatisfactory general condition for evaluation, or an inability
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 |
|---|---|---|
| electrode position | Procedure or surgery | electrode position, STN DBS, Parkinson' disease |
Primary outcome
To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT
Time frame: at 1 month after surgery
1 secondary outcome
UPDRS, H&Y, ADL scores, LEDD
Time frame: at 6 and 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
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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.
Department of Neurosurgery, Seoul National University Hospital
Seoul, South Korea
Sun Ha Paek, M.D., Ph.D. principal investigator
Department of Neurosurgery, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrode position 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 1 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 30 Nov 2015. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT (time frame: at 1 month after 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 30 Nov 2015.