Parkinson DiseaseNCT04976569
Neuromodulation of Sleep Architecture by STN-DBS in Parkinsonian Patients
A study testing STN-DBS stimulation pattern change in people with Parkinson Disease and Sleep Disorder, run by Tsinghua University at 1 site in China.
Trial summary
Sleep disorder is one of the most burdensome non-motor symptoms in Parkinsonian patients. Typical manifestations include RBD, decreased sleep efficiency, decreased slow wave sleep, daytime sleepiness, increased sleep latency and wakefulness during sleep. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Parkinson Disease, Sleep Disorder
- What is being tested?
- STN-DBS stimulation pattern change
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2021to 10 Dec 2023
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's disease: The diagnostic criteria for Parkinson's disease are the Clinical Diagnostic Criteria of UK PD Society Brain Bank Clinical Diagnostic Criteria or 2015 MDS Clinical Diagnostic Criteria for PD.All diagnoses of Parkinson's disease were made by three neurologists who were experienced in the field of movement disorders.
- Bilateral STN-DBS has been implanted for more than 1 year, and stable drug therapy regimen and parameter program control regimen have been maintained for 6 weeks or more;
- Patients with onset age of 50 years and above;
- Do not use phenobarbital, chloral hydrate, benzodiazepines and non-benzodiazepines as sedatives and hypnotics at night.
Who cannot join
- Patients who underwent pallidotomy and other brain surgery;
- Other patients with secondary Parkinson's syndrome and Parkinsonism-plus syndrome;
- Patients with other central nervous system and peripheral nervous system diseases;
- Patients complicated with severe medical system diseases, patients with unstable vital signs and unable to tolerate clinical evaluation;
- Patients with severe mental illness;
- Use phenobarbital, chloral hydrate, benzodiazepines and non-benzodiazepines as sedatives and hypnotics at night;
- Patients who cannot complete informed consent due to cognitive and communication barriers, or refuse to sign informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Engineering Laboratory for Neuromodulation
Beijing, Beijing Municipality
Huiling Yu, MD, yuhuiling@mail.tsinghua.edu.cn
About this study
Sleep disorder is one of the most burdensome non-motor symptoms in Parkinsonian patients. Typical manifestations include RBD, decreased sleep efficiency, decreased slow wave sleep, daytime sleepiness, increased sleep latency and wakefulness during sleep. Subthalamic nucleus (STN) deep brain stimulation (DBS) has been reported to improve sleep dysfunction in several studies, mostly due to its improvement in motor dysfunction. However, there are limited research about specific STN-DBS stimulation pattern for sleep architecture regulation, and whether suboptimal parameter combinations for motor has potential benefits for sleep improvement has not been studied. Here we use different parameter combination in STN-DBS, especially by changing stimulation contact and frequency, to explore the specific stimulation pattern for normalizing sleep architecture and increasing slow wave sleep.
Read the detailed description
Investigators will enroll at least 5 subjects for this study. First, subjects will be clinically evaluated by motor, cognitive and sleep scales; Subsequently, the treatment window of each contact using unipolar stimulation will be tested both in high frequency (such as 130Hz) and low frequency (such as 80Hz), and the parameters of stimulation were determined under the premise of no obvious discomfort and optimal motor control. Different stimulation pattern (such as ventral contact stimulation) will be performed during the N2 phase combined with PSG and LFP recording during the patients' sleep, and switch to baseline stimulation pattern at the N3/N1/REM phase. Repeat these steps until the patient wake up naturally. Finally, the patients will be evaluated for motor function. Pre-surgery and post-surgery images will be used for reconstructing VTA of specific parameter combination. Functional MRI (fMRI) will be carried out to verify the connectivity change under optimal parameter combinations.
- Conditions
- Parkinson Disease, Sleep Disorder
- Being tested
- STN-DBS stimulation pattern change
- Medical subject headings
- Parkinson Disease, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STN-DBS stimulation pattern changeDevice
Deep brain stimulation (DBS) is an elective surgical procedure in which electrodes are implanted into certain brain areas.We use specific STN-DBS stimulation pattern to regulate sleep architecture.
| Study group | Role | What they receive |
|---|---|---|
| DBS Regulation Group | Experimental | All participants will receive STN-DBS sleep regulation. Receives: Device: STN-DBS stimulation pattern change |
What is being measured
The primary outcome is the main question the study is designed to answer.
ratio of slow wave sleep
The percentage of slow wave sleep
Measured: through study completion, an average of 1 year
ratio of rem sleep
The percentage of rem sleep
Measured: through study completion, an average of 1 year
Sleep Efficiency
The percentage of time a person sleeps, in relation to the amount of time a person spends in bed
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Motor Function Evaluation
Using MDS-UPDRS III to evaluation motor function both before and after whole night sleep to verify influence of different stimulation pattern on motor function during sleep.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start10 Aug 2021
- Primary completion10 Dec 2023 (estimated)
- Study completion10 Dec 2023 (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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tsinghua University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tsinghua Changgeng Hospital
- Responsible party
- Principal investigator, Luming Li, Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976569
- Sponsor's protocol ID
- STN_DBS_Sleep_TsinghuaU
- Status last verified
- May 2023
- First submitted
- 16 Jun 2021
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation of Sleep Architecture by STN-DBS in Parkinsonian Patients
- ClinicalTrials.gov ID
- NCT04976569
- Acronym / sponsor ID
- STN_DBS_Sleep_TsinghuaU
- Conditions
- Parkinson Disease, Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Tsinghua UniversityUniversity, hospital or other
- Collaborators
- Beijing Tsinghua Changgeng Hospital
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 10 Dec 2023 (estimated)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 26 Jul 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.
Sleep disorder is one of the most burdensome non-motor symptoms in Parkinsonian patients. Typical manifestations include RBD, decreased sleep efficiency, decreased slow wave sleep, daytime sleepiness, increased sleep latency and wakefulness during sleep. Subthalamic nucleus (STN) deep brain stimulation (DBS) has been reported to improve sleep dysfunction in several studies, mostly due to its improvement in motor dysfunction. However, there are limited research about specific STN-DBS stimulation pattern for sleep architecture regulation, and whether suboptimal parameter combinations for motor has potential benefits for sleep improvement has not been studied. Here we use different parameter combination in STN-DBS, especially by changing stimulation contact and frequency, to explore the specific stimulation pattern for normalizing sleep architecture and increasing slow wave sleep.
Detailed description
Investigators will enroll at least 5 subjects for this study. First, subjects will be clinically evaluated by motor, cognitive and sleep scales; Subsequently, the treatment window of each contact using unipolar stimulation will be tested both in high frequency (such as 130Hz) and low frequency (such as 80Hz), and the parameters of stimulation were determined under the premise of no obvious discomfort and optimal motor control. Different stimulation pattern (such as ventral contact stimulation) will be performed during the N2 phase combined with PSG and LFP recording during the patients' sleep, and switch to baseline stimulation pattern at the N3/N1/REM phase. Repeat these steps until the patient wake up naturally. Finally, the patients will be evaluated for motor function. Pre-surgery and post-surgery images will be used for reconstructing VTA of specific parameter combination. Functional MRI (fMRI) will be carried out to verify the connectivity change under optimal parameter combinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBS Regulation Group | Experimental | Device: STN-DBS stimulation pattern changeAll participants will receive STN-DBS sleep regulation. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Parkinson's disease: The diagnostic criteria for Parkinson's disease are the Clinical Diagnostic Criteria of UK PD Society Brain Bank Clinical Diagnostic Criteria or 2015 MDS Clinical Diagnostic Criteria for PD.All diagnoses of Parkinson's disease were made by three neurologists who were experienced in the field of movement disorders.
- Bilateral STN-DBS has been implanted for more than 1 year, and stable drug therapy regimen and parameter program control regimen have been maintained for 6 weeks or more;
- Patients with onset age of 50 years and above;
- Do not use phenobarbital, chloral hydrate, benzodiazepines and non-benzodiazepines as sedatives and hypnotics at night.
Key exclusion criteria (7 listed)
- Patients who underwent pallidotomy and other brain surgery;
- Other patients with secondary Parkinson's syndrome and Parkinsonism-plus syndrome;
- Patients with other central nervous system and peripheral nervous system diseases;
- Patients complicated with severe medical system diseases, patients with unstable vital signs and unable to tolerate clinical evaluation;
- Patients with severe mental illness;
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 |
|---|---|---|
| STN-DBS stimulation pattern changeDeep brain stimulation (DBS) is an elective surgical procedure in which electrodes are implanted into certain brain areas.We use specific STN-DBS stimulation pattern to regulate sleep architecture. | Device | DBS Regulation Group |
Primary outcome
ratio of slow wave sleep
Time frame: through study completion, an average of 1 year
The percentage of slow wave sleep
ratio of rem sleep
Time frame: through study completion, an average of 1 year
The percentage of rem sleep
Sleep Efficiency
Time frame: through study completion, an average of 1 year
The percentage of time a person sleeps, in relation to the amount of time a person spends in bed
1 secondary outcome
Motor Function Evaluation
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 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 STN-DBS stimulation pattern change in people with Parkinson Disease and Sleep Disorder, 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 4 inclusion and 7 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 May 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?
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?
ratio of slow wave sleep (time frame: through study completion, an average of 1 year). 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 30 May 2023.