Neurocognitive DisordersNCT04696978
Study for Perioperative Neurocognitive Disorders After Deep Brain Stimulation Surgery for Parkinson's Disease
An observational study of Neurocognitive Disorders, run by wenbinlu at 1 site in China.
Trial summary
Perioperative neurocognitive disorders(PND) is common to see in elderly patients. Although PND increases patient mortality as well as hospitalization time, apparent inflammatory factors, and related mechanisms are still unknown. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurocognitive Disorders
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 1 Dec 2022
- How long will I take part?
- 1 Month
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: we select Parkinson's patients undergoing elective DBS and observe who occur PND or not.
Who may be able to join
- Parkinson's patients undergoing elective deep brain stimulation
- Age ≥55 years
- ASA physical statusⅠ-Ⅲ
- Elementary school or above
Who cannot join
- patients with ASA physical status>III
- patients with systemic immune diseases, hematological diseases (hematological tumors or leukemia), patients after transplantation, malignant tumors
- patients with metabolic diseases such as diabetes, ketoacidosis, hyperosmolar syndrome, long-term hypoglycemia,gout
- patients who refused to join the study and lost to follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital, Second Military Medical University
Shanghai, Shanghai Municipality
jinjun bian, M.D, 13601963321, jinjunbicu@163.com
About this study
Official title: Metabonomics Characteristics and Predictive Value for Perioperative Neurocognitive Disorders After Deep Brain Stimulation Surgery for Parkinson's Disease
Perioperative neurocognitive disorders(PND) is common to see in elderly patients. Although PND increases patient mortality as well as hospitalization time, apparent inflammatory factors, and related mechanisms are still unknown. Metabolites could reveal chemical fingerprints left behind by cellular processes, which in turn provide a new aspect to understand the biological process behind. we aim to found the metabolomics can aid the development of diagnostic markers of PND screening, early detection, and further, provide a basis for disease prevention and treatment.
- Conditions
- Neurocognitive Disorders
- Medical subject headings
- Neurocognitive Disorders
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 |
|---|---|---|
| PND group | patients occur neurocognitive disorders according to scores in this group | |
| NO PND group | patients do not occur neurocognitive disorders according to scores in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the level of metabolomics in patients' blood sample
Measured: baseline
the level of metabolomics in patients' blood sample
Measured: 24 hours after operation
the level of metabolomics in patients' blood sample
Measured: 72 hours after operation
Secondary outcomes (4)
CAM-ICU score
Measured: baseline
CAM-ICU score
Measured: 24 hours after operation
CAM-ICU score
Measured: 72 hours after operation
CAM-ICU score
Measured: 1 month after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Aug 2020
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- wenbinlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, wenbinlu, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696978
- Sponsor's protocol ID
- PND-PD
- Status last verified
- Jan 2021
- First submitted
- 23 Dec 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabonomics Characteristics and Predictive Value for Perioperative Neurocognitive Disorders After Deep Brain Stimulation Surgery for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04696978
- Acronym / sponsor ID
- PND-PD
- Conditions
- Neurocognitive Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- wenbinluUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 6 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.
Perioperative neurocognitive disorders(PND) is common to see in elderly patients. Although PND increases patient mortality as well as hospitalization time, apparent inflammatory factors, and related mechanisms are still unknown. Metabolites could reveal chemical fingerprints left behind by cellular processes, which in turn provide a new aspect to understand the biological process behind. we aim to found the metabolomics can aid the development of diagnostic markers of PND screening, early detection, and further, provide a basis for disease prevention and treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PND group | – | –patients occur neurocognitive disorders according to scores in this group |
| NO PND group | – | –patients do not occur neurocognitive disorders according to scores in this group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- we select Parkinson's patients undergoing elective DBS and observe who occur PND or not.
Key inclusion criteria (4 listed)
- Parkinson's patients undergoing elective deep brain stimulation
- Age ≥55 years
- ASA physical statusⅠ-Ⅲ
- Elementary school or above
Key exclusion criteria (4 listed)
- patients with ASA physical status>III
- patients with systemic immune diseases, hematological diseases (hematological tumors or leukemia), patients after transplantation, malignant tumors
- patients with metabolic diseases such as diabetes, ketoacidosis, hyperosmolar syndrome, long-term hypoglycemia,gout
- patients who refused to join the study and lost to follow-up
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
the level of metabolomics in patients' blood sample
Time frame: baseline
the level of metabolomics in patients' blood sample
Time frame: 24 hours after operation
the level of metabolomics in patients' blood sample
Time frame: 72 hours after operation
4 secondary outcomes
CAM-ICU score
Time frame: baseline
CAM-ICU score
Time frame: 24 hours after operation
CAM-ICU score
Time frame: 72 hours after operation
CAM-ICU score
Time frame: 1 month after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
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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.
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 Neurocognitive Disorders, run by wenbinlu 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 4 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 6 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wenbin lu (13004162573, 13004162573@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the level of metabolomics in patients' blood sample (time frame: baseline). The study lists 3 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 6 Jan 2021.