Parkinson DiseaseNCT06012461
Closed-loop DBS in Parkinson's Disease
A study testing Closed-loop DBS stimulation for 24 hours, Open-loop DBS stimulation for 24 hours and Closed-loop DBS stimulation for 72 hours in people with Parkinson Disease, run by Tsinghua University at 1 site in China.
Trial summary
Closed-loop DBS is an emerging neuromodulation pattern in Parkinson's disease with dyanmic adjustment of stimulation parameters to patients' disease fluctuations and state of activity. The purpose of this study is to verify the long-term safety and effectiveness of closed-loop DBS. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Closed-loop DBS stimulation for 24 hours, Open-loop DBS stimulation for 24 hours and Closed-loop DBS stimulation for 72 hours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2023to 30 Dec 2025
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary Parkinson's disease: Diagnosis of primary Parkinson's disease should meet the diagnostic criteria outlined in the "Diagnosis Standards for Parkinson's Disease in China" published in 2016 or the diagnostic criteria for primary Parkinson's disease by the International Parkinson and Movement Disorder Society (MDS) published in 2015.
- Good response to levodopa combination therapy.
- Significant reduction in drug efficacy or significant impact on the patient's quality of life due to prominent motor complications.
- Intolerable adverse reactions to medication affecting its efficacy.
- Presence of uncontrollable tremors despite medication.
Who cannot join
- Patients who have undergone pallidotomy or other brain surgeries.
- Patients with secondary Parkinson syndromes or Parkinson plus syndromes.
- Patients with concurrent central nervous system and peripheral nervous system diseases.
- Patients with severe systemic diseases, unstable vital signs, or those who cannot tolerate clinical assessments.
- Patients with severe psychiatric disorders.
- Patients who are unable to provide informed consent due to cognitive or communication impairments or those who refuse to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Engineering Research Center of Neuromodulation
Beijing, Beijing Municipality, 100084
Huiling Yu, M.D., 86-010-62794952, hellokittylene@163.com
Luming Li, Ph.D.
About this study
Official title: Safety and Effectiveness of Closed-loop DBS in Parkinson's Disease: A Long-term Follow-up Study
Closed-loop DBS is an emerging neuromodulation pattern in Parkinson's disease with dyanmic adjustment of stimulation parameters to patients' disease fluctuations and state of activity. The purpose of this study is to verify the long-term safety and effectiveness of closed-loop DBS. Through comparing with open-loop DBS, the study also determine whether closed-loop DBS is more effective than conventional open-loop DBS on PD treatment.
- Conditions
- Parkinson Disease
- Being tested
- Closed-loop DBS stimulation for 24 hours, Open-loop DBS stimulation for 24 hours, Closed-loop DBS stimulation for 72 hours, Open-loop DBS stimulation for 72 hours
- Keywords
- Parkinson Disease, Deep Brain Stimulation, Closed-loop DBS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop DBS stimulation for 24 hoursOther
Continuous closed-loop modulation for 24 hours
Open-loop DBS stimulation for 24 hoursOther
Continuous open-loop modulation for 24 hours
Closed-loop DBS stimulation for 72 hoursOther
Continuous closed-loop modulation for 72 hours
Open-loop DBS stimulation for 72 hoursOther
Continuous open-loop modulation for 72 hours
| Study group | Role | What they receive |
|---|---|---|
| Bilateral STN DBS Modulation | Experimental | Participants will be implanted with bilateral STN DBS using PINS 106RS system. DBS stimulation will be initiated one month post surgery. Follow-up visits will be conducted 1/3/6/9/12/15 months post surgery with clinical evaluation, STN LFP recording and resting state functional MRI testing. During the 6-15 month's visit, short-term closed-loop DBS modulation (from 24hours to 72hours ) will be conducted to test the safety and efficacy of closed-loop DBS therapy. Receives: Other: Closed-loop DBS stimulation for 24 hours; Other: Open-loop DBS stimulation for 24 hours; Other: Closed-loop DBS stimulation for 72 hours; Other: Open-loop DBS stimulation for 72 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement disorders evaluation
Using MDS-UPDRS III rating scale （0-132, the higher score means a worse outcome） and Rush dyskinesia rating scale （0-12, the higher score means a worse outcome） combined with IMU to evaluate the motor function improvement under both closed-loop DBS and open-loop DBS condition
Measured: 1-3 days
Sleep Structure Evaluation
Using polysomnography evaluation （sleep efficiency，N1/N2/N3/REM/Wake after sleep onset duration and percentage，arousal index） and subjuective sleep quality rating scale to evaluate the sleep improvement under both closed-loop DBS and open-loop DBS condition
Measured: 1-3 nights
Diary Outcomes in Parkinson's Disease
Using SCOPA-DC （0-87, the higher score means a worse outcome） to evaluate the diary outcomes under both closed-loop DBS and open-loop DBS condition
Measured: 1-3days
Secondary outcomes (2)
Safety (Stimulation-related AEs) and Subjective Satisfactory
Number of modulation related Adverse Events or abnormal vital signs.
Measured: 1-3days
Total Electrical Energy Delivered to patients
To evaluate the energy changes in closed-loop DBS and open-loop DBS modualtion
Measured: 1-3days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start30 Jun 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tsinghua University
- Sponsor type
- University, hospital or other
- Collaborators
- National Engineering Research Center of Neuromodulation, Tsinghua University, Beijing Tiantan Hospital, Peking Union Medical College Hospital, Beijing Pins Medical Co., Ltd
- Responsible party
- Principal investigator, Luming Li, Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012461
- Sponsor's protocol ID
- CDBS_PD_2023
- Status last verified
- Aug 2023
- First submitted
- 18 Jun 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Closed-loop DBS in Parkinson's Disease: A Long-term Follow-up Study
- ClinicalTrials.gov ID
- NCT06012461
- Acronym / sponsor ID
- CDBS_PD_2023
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Deep Brain Stimulation, Closed-loop DBS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tsinghua UniversityUniversity, hospital or other
- Collaborators
- National Engineering Research Center of Neuromodulation, Tsinghua University, Beijing Tiantan Hospital, Peking Union Medical College Hospital, Beijing Pins Medical Co., Ltd
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 25 Aug 2023 (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.
Closed-loop DBS is an emerging neuromodulation pattern in Parkinson's disease with dyanmic adjustment of stimulation parameters to patients' disease fluctuations and state of activity. The purpose of this study is to verify the long-term safety and effectiveness of closed-loop DBS. Through comparing with open-loop DBS, the study also determine whether closed-loop DBS is more effective than conventional open-loop DBS on PD treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral STN DBS Modulation | Experimental | Other: Closed-loop DBS stimulation for 24 hours, Other: Open-loop DBS stimulation for 24 hours, Other: Closed-loop DBS stimulation for 72 hours, Other: Open-loop DBS stimulation for 72 hoursParticipants will be implanted with bilateral STN DBS using PINS 106RS system. DBS stimulation will be initiated one month post surgery. Follow-up visits will be conducted 1/3/6/9/12/15 months post surgery with clinical evaluation, STN LFP recording and resting state functional MRI testing. During the 6-15 month's visit, short-term closed-loop DBS modulation (from 24hours to 72hours ) will be conducted to test the safety and efficacy of closed-loop DBS therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of primary Parkinson's disease: Diagnosis of primary Parkinson's disease should meet the diagnostic criteria outlined in the "Diagnosis Standards for Parkinson's Disease in China" published in 2016 or the diagnostic criteria for primary Parkinson's disease by the International Parkinson and Movement Disorder Society (MDS) published in 2015.
- Good response to levodopa combination therapy.
- Significant reduction in drug efficacy or significant impact on the patient's quality of life due to prominent motor complications.
- Intolerable adverse reactions to medication affecting its efficacy.
- Presence of uncontrollable tremors despite medication.
Key exclusion criteria (6 listed)
- Patients who have undergone pallidotomy or other brain surgeries.
- Patients with secondary Parkinson syndromes or Parkinson plus syndromes.
- Patients with concurrent central nervous system and peripheral nervous system diseases.
- Patients with severe systemic diseases, unstable vital signs, or those who cannot tolerate clinical assessments.
- Patients with severe psychiatric disorders.
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 |
|---|---|---|
| Closed-loop DBS stimulation for 24 hoursContinuous closed-loop modulation for 24 hours | Other | Bilateral STN DBS Modulation |
| Open-loop DBS stimulation for 24 hoursContinuous open-loop modulation for 24 hours | Other | Bilateral STN DBS Modulation |
| Closed-loop DBS stimulation for 72 hoursContinuous closed-loop modulation for 72 hours | Other | Bilateral STN DBS Modulation |
| Open-loop DBS stimulation for 72 hoursContinuous open-loop modulation for 72 hours | Other | Bilateral STN DBS Modulation |
Primary outcome
Movement disorders evaluation
Time frame: 1-3 days
Using MDS-UPDRS III rating scale （0-132, the higher score means a worse outcome） and Rush dyskinesia rating scale （0-12, the higher score means a worse outcome） combined with IMU to evaluate the motor function improvement under both closed-loop DBS and open-loop DBS condition
Sleep Structure Evaluation
Time frame: 1-3 nights
Using polysomnography evaluation （sleep efficiency，N1/N2/N3/REM/Wake after sleep onset duration and percentage，arousal index） and subjuective sleep quality rating scale to evaluate the sleep improvement under both closed-loop DBS and open-loop DBS condition
Diary Outcomes in Parkinson's Disease
Time frame: 1-3days
Using SCOPA-DC （0-87, the higher score means a worse outcome） to evaluate the diary outcomes under both closed-loop DBS and open-loop DBS condition
2 secondary outcomes
Safety (Stimulation-related AEs) and Subjective Satisfactory
Time frame: 1-3days
Total Electrical Energy Delivered to patients
Time frame: 1-3days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed-loop DBS stimulation for 24 hours, Open-loop DBS stimulation for 24 hours and Closed-loop DBS stimulation for 72 hours in people with Parkinson Disease, run by Tsinghua 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 5 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 5 Sep 2023. 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 Weizhi Pan, B.S. (+86-010-62796172, neln@mail.tsinghua.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement disorders evaluation (time frame: 1-3 days). 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 5 Sep 2023.