Parkinson DiseaseNCT04707638
Neurophysiological Characteristics of Subthalamic Deep-brain Stimulation (STN-DBS)
An observational study of Parkinson Disease and Dystonia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
The intraoperative neuroelectrophysiological signals were collected from patients undergoing STN-DBS under general anesthesia in the Neurosurgery Department of Wuhan union Hospital, and their preoperative conditions and postoperative efficacy will be evaluated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Dystonia
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 11 Jan 2023
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Parkinson's disease or dystonia and STN-DBS in neurosurgery department of Wuhan Union Hospital.
Who may be able to join
- Patients underwentSTN-DBS in neurosurgery department of Wuhan Union Hospital.
- Patients with Parkinson's disease or dystonia.
Who cannot join
- 1.Patients without enough follow-up length.
About this study
Official title: Neurophysiological Characteristics of Subthalamic Deep-brain Stimulation (STN-DBS) Under General Anesthesia for Patients With Parkinson's Disease or Dystonia and Their Correlation With Prognosis
The intraoperative neuroelectrophysiological signals were collected from patients undergoing STN-DBS under general anesthesia in the Neurosurgery Department of Wuhan union Hospital, and their preoperative conditions and postoperative efficacy will be evaluated.
Read the detailed description
The intraoperative neuroelectrophysiological signals were collected from patients undergoing STN-DBS under general anesthesia in the Neurosurgery Department of Wuhan union Hospital, and their preoperative conditions and postoperative efficacy will be evaluated. The intraoperative neuroelectrophysiological signals would be analyzed.
- Conditions
- Parkinson Disease, Dystonia
- Being tested
- No intervention used
- Keywords
- Parkinson Disease, Dystonia, deep brain stimultation, neurophysiological characteristics
- Medical subject headings
- Parkinson Disease, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention usedOther
No intervention used
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease or dystonia patients | Patients with Parkinson's disease or dystonia and underwent STN DBS under general anesthesia in neurosurgery department Receives: Other: No intervention used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale (UPDRS)
UPDRS has four parts: part I (nonmotor experiences of daily living, total score=16); part II (patient motor experience of daily living, total score=52); part III (clinician motor examination, total score=56); part IV (complications, total score=23). The total score of all the four parts is147. Higher scores means a worse outcome.
Measured: Two years postoperatively
Burke Fahn Marsden's Dystonia Rating Scales(BFMDRS)
BFMDRS has two parts: BFMDRS movement part (BFMDRS-M) and BFMDRS disability part (BFMDRS-D). The total score of BFMDRS-M is 120 and the total score of BFMDRS-D is 30. Higher scores means a worse outcome.
Measured: Two years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Jan 2021
- Primary completion11 Jan 2023 (estimated)
- Study completion11 Jan 2023 (estimated)
Why it stopped: Ethics application has not been completed yet
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Cross-sectional
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Huazhong University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Fu Peng, PHD, Principal investigator, Neurosurgery department of Wuhan Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707638
- Sponsor's protocol ID
- NS20201230
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsai ST, Kuo CC, Chen TY, Chen SY. Neurophysiological comparisons of subthalamic deep-brain stimulation for Parkinson's disease between patients receiving general and local anesthesia. Tzu Chi Med J. 2016 Apr-Jun;28(2):63-67. doi: 10.1016/j.tcmj.2016.02.003. Epub 2016 Apr 10.
PubMed 28757724Yamada K, Goto S, Kuratsu J, Matsuzaki K, Tamura T, Nagahiro S, Murase N, Shimazu H, Kaji R. Stereotactic surgery for subthalamic nucleus stimulation under general anesthesia: a retrospective evaluation of Japanese patients with Parkinson's disease. Parkinsonism Relat Disord. 2007 Mar;13(2):101-7. doi: 10.1016/j.parkreldis.2006.07.008. Epub 2006 Oct 19.
PubMed 17055325
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Characteristics of Subthalamic Deep-brain Stimulation (STN-DBS) Under General Anesthesia for Patients With Parkinson's Disease or Dystonia and Their Correlation With Prognosis
- ClinicalTrials.gov ID
- NCT04707638
- Acronym / sponsor ID
- NS20201230
- Conditions
- Parkinson Disease, Dystonia
- Keywords
- Parkinson Disease, Dystonia, deep brain stimultation, neurophysiological characteristics
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Ethics application has not been completed yet
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Huazhong University of Science and Technology
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 11 Jan 2023 (estimated)
- Study completion
- 11 Jan 2023 (estimated)
- First posted
- 13 Jan 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 intraoperative neuroelectrophysiological signals were collected from patients undergoing STN-DBS under general anesthesia in the Neurosurgery Department of Wuhan union Hospital, and their preoperative conditions and postoperative efficacy will be evaluated.
Detailed description
The intraoperative neuroelectrophysiological signals were collected from patients undergoing STN-DBS under general anesthesia in the Neurosurgery Department of Wuhan union Hospital, and their preoperative conditions and postoperative efficacy will be evaluated. The intraoperative neuroelectrophysiological signals would be analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease or dystonia patients | – | Other: No intervention usedPatients with Parkinson's disease or dystonia and underwent STN DBS under general anesthesia in neurosurgery department |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Parkinson's disease or dystonia and STN-DBS in neurosurgery department of Wuhan Union Hospital.
Key inclusion criteria (2 listed)
- Patients underwentSTN-DBS in neurosurgery department of Wuhan Union Hospital.
- Patients with Parkinson's disease or dystonia.
Key exclusion criteria (1 listed)
- 1.Patients without enough follow-up length.
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 |
|---|---|---|
| No intervention usedNo intervention used | Other | Parkinson's disease or dystonia patients |
Primary outcome
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: Two years postoperatively
UPDRS has four parts: part I (nonmotor experiences of daily living, total score=16); part II (patient motor experience of daily living, total score=52); part III (clinician motor examination, total score=56); part IV (complications, total score=23). The total score of all the four parts is147. Higher scores means a worse outcome.
Burke Fahn Marsden's Dystonia Rating Scales(BFMDRS)
Time frame: Two years postoperatively
BFMDRS has two parts: BFMDRS movement part (BFMDRS-M) and BFMDRS disability part (BFMDRS-D). The total score of BFMDRS-M is 120 and the total score of BFMDRS-D is 30. Higher scores means a worse outcome.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Background: PubMed 28757724Tsai ST, Kuo CC, Chen TY, Chen SY. Neurophysiological comparisons of subthalamic deep-brain stimulation for Parkinson's disease between patients receiving general and local anesthesia. Tzu Chi Med J. 2016 Apr-Jun;28(2):63-67. doi: 10.1016/j.tcmj.2016.02.003. Epub 2016 Apr 10.
- Background: PubMed 17055325Yamada K, Goto S, Kuratsu J, Matsuzaki K, Tamura T, Nagahiro S, Murase N, Shimazu H, Kaji R. Stereotactic surgery for subthalamic nucleus stimulation under general anesthesia: a retrospective evaluation of Japanese patients with Parkinson's disease. Parkinsonism Relat Disord. 2007 Mar;13(2):101-7. doi: 10.1016/j.parkreldis.2006.07.008. Epub 2006 Oct 19.
- 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.
Fu Peng, PHD principal investigator
Neurosurgery department of Wuhan Union Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Dystonia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Unified Parkinson's Disease Rating Scale (UPDRS) (time frame: Two years postoperatively). 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?
On the ClinicalTrials.gov record for NCT04707638, which also lists 2 linked publications.
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 3 Feb 2021.