Deep Brain StimulationNCT04855344
Deep Brain Stimulation Therapy and Intestinal Microbiota
An observational study of Deep Brain Stimulation and Gastrointestinal Microbiome, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study aims to observe the changes of intestinal microbiota after deep brain stimulation (DBS) therapy for Parkinson's disease, and explore the role of intestinal microbiota in the neuroprotective effect of DBS. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Deep Brain Stimulation, Gastrointestinal Microbiome
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2021to 31 Dec 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's disease and are expected to undergo DBS therapy
Who may be able to join
- > 18 years of age;
- Primary Parkinson's disease diagnosed according to British Brain Bank criteria (Hoehn and Yahr);
- Deep brain stimulator therapy;
- Sign the informed consent.
Who cannot join
- Use of probiotics or probiotics during the study;
- Use antibiotics against intestinal bacteria at present or within the last 1 month;
- With cognitive dysfunction or mental illness;
- With severe diseases or is not expected to survive for more than a year;
- A history of gastrointestinal surgery;
- AIDS patients, hepatitis B/C positive.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Hospital Research Ethics Committee of the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Yue Wang, jsphkjwy@163.com
About this study
Official title: Effect of Deep Brain Stimulation Therapy on Intestinal Microbiota in Patients With Parkinson's Disease
This study aims to observe the changes of intestinal microbiota after deep brain stimulation (DBS) therapy for Parkinson's disease, and explore the role of intestinal microbiota in the neuroprotective effect of DBS.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gut microbiota
Analyzed by 16sRNA sequencing of feces
Measured: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
Change in gut microbiota
Analyzed by 16sRNA sequencing of feces
Measured: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Secondary outcomes (10)
Change in blood biomarkers of neuroinflammation and alpha-synuclein
Comparing the changes of blood biomarkers such as neuroinflammation (TNF-alpha, IL-6, LPS) and alpha-synuclein
Measured: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
Change in blood biomarkers of neuroinflammation and alpha-synuclein
Comparing the changes of blood biomarkers such as neuroinflammation (TNF-alpha, IL-6, LPS) and alpha-synuclein
Measured: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Frequency of defecation
Measured: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
Frequency of defecation
Measured: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Dosage of anti-Parkinson's agent
Measured: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
Dosage of anti-Parkinson's agent
Measured: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Change in the score of Unified Parkinson's Disease Rating Scales
It is consisted of six scales, each scale is graded on a scale of 5 (0-4), with zero being normal and 4 being severe.
Measured: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
Change in the score of Unified Parkinson's Disease Rating Scales
It is consisted of six scales, each scale is graded on a scale of 5 (0-4), with zero being normal and 4 being severe.
Measured: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39)
Change in PDQ-39 scores, higher scores mean a worse outcome
Measured: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39)
Change in PDQ-39 scores, higher scores mean a worse outcome
Measured: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start15 Apr 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Brain StimulationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cunming Liu, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855344
- Sponsor's protocol ID
- Ling Zhou
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 22 Apr 2021
- 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 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Deep Brain Stimulation Therapy on Intestinal Microbiota in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04855344
- Acronym / sponsor ID
- Ling Zhou
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 Apr 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Apr 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.
This study aims to observe the changes of intestinal microbiota after deep brain stimulation (DBS) therapy for Parkinson's disease, and explore the role of intestinal microbiota in the neuroprotective effect of DBS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease and are expected to undergo DBS therapy
Key inclusion criteria (4 listed)
- > 18 years of age;
- Primary Parkinson's disease diagnosed according to British Brain Bank criteria (Hoehn and Yahr);
- Deep brain stimulator therapy;
- Sign the informed consent.
Key exclusion criteria (6 listed)
- Use of probiotics or probiotics during the study;
- Use antibiotics against intestinal bacteria at present or within the last 1 month;
- With cognitive dysfunction or mental illness;
- With severe diseases or is not expected to survive for more than a year;
- A history of gastrointestinal surgery;
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
Change in gut microbiota
Time frame: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
Analyzed by 16sRNA sequencing of feces
Change in gut microbiota
Time frame: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Analyzed by 16sRNA sequencing of feces
10 secondary outcomes
Change in blood biomarkers of neuroinflammation and alpha-synuclein
Time frame: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
Change in blood biomarkers of neuroinflammation and alpha-synuclein
Time frame: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Frequency of defecation
Time frame: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
Frequency of defecation
Time frame: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Dosage of anti-Parkinson's agent
Time frame: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
Dosage of anti-Parkinson's agent
Time frame: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Change in the score of Unified Parkinson's Disease Rating Scales
Time frame: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
Change in the score of Unified Parkinson's Disease Rating Scales
Time frame: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39)
Time frame: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy
Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39)
Time frame: Baseline (Before deep brain stimulation therapy)/6 month after deep brain stimulation therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 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.
Cunming Liu study chair
The First Affiliated Hospital with Nanjing Medical University
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 Deep Brain Stimulation and Gastrointestinal Microbiome, run by The First Affiliated Hospital with Nanjing Medical University 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 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 22 Apr 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 Ling Zhou (+8615895918786, lingzhou531@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gut microbiota (time frame: Baseline (Before deep brain stimulation therapy)/3 month after deep brain stimulation therapy). 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?
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 22 Apr 2021.