Deep Brain StimulationNCT06914466
Neural Mechanisms and Clinical Applications of DBS for Modulating Sleep Dysregulation in PD
An observational study of Deep Brain Stimulation and Parkinson's Disease and Parkinsonism, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Parkinson's disease (PD) is a prevalent neurodegenerative disorder characterized by both motor and non-motor symptoms. Subthalamic nucleus (STN) deep brain stimulation (DBS) effectively alleviates motor symptoms; however, non-motor symptoms such as sleep disorders significantly impair patients' quality of life. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Deep Brain Stimulation, Parkinson's Disease and Parkinsonism, Sleep Disorder
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's Disease who 2.underwent bilateral STN-DBS(Medtronic Percept™ PC) and consent to participate in the sleep study.
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.
- Patients who underwent bilateral STN-DBS(Medtronic Percept™ PC)
- Patients who can cooperate with the completion of postoperative follow-up and clinical evaluation.
Who cannot join
- Patients who underwent 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, or unable to tolerate clinical evaluation;
- Patients with severe mental illness;
- 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, 100053
Jiping Li, MD, 8610-83198899-8630, yhljp89@163.com
Yuqing Zhang, MD
About this study
Official title: Neural Mechanisms and Clinical Applications of Deep Brain Stimulation for Modulating Sleep Dysregulation in Parkinson's Disease
Parkinson's disease (PD) is a prevalent neurodegenerative disorder characterized by both motor and non-motor symptoms. Subthalamic nucleus (STN) deep brain stimulation (DBS) effectively alleviates motor symptoms; however, non-motor symptoms such as sleep disorders significantly impair patients' quality of life. While preliminary evidence suggests DBS may improve sleep, the underlying neural mechanisms and long-term effects on sleep regulation remain poorly elucidated. This study employs a wearable polysomnography (PSG) device to investigate how STN-DBS modulates sleep architecture, local field potentials (LFPs), and clinical outcomes in PD patients. We hypothesize that STN-DBS contributes to both the regulation and disruption of normal sleep behavior. By synchronizing PSG with STN-LFP recordings under DBS-ON and DBS-OFF conditions, we aim to decode sleep stages using STN-LFPs, characterize PD-specific sleep abnormalities (e.g., sleep architecture, atonia), and analyze DBS-induced LFP changes and their correlations with clinical efficacy. According to the above data, the sleep stage characteristics were decoded, and the algorithm was used to determine the optimal clinical threshold current amplitude to improve sleep. Then, the patients will be given adaptive stimulation, and the sleep quality was monitored to verify its efficacy.This study will provide a neurophysiological foundation for developing closed-loop stimulation strategies targeting sleep dysfunction in PD.
Read the detailed description
This single-center longitudinal observational study will enroll 20 idiopathic Parkinson's disease (PD) patients with bilateral subthalamic nucleus (STN) deep brain stimulation (DBS) systems (Medtronic Percept™ PC) to evaluate the neurophysiological mechanisms of DBS in sleep regulation. Participants will undergo preoperative clinical assessments (MDS-UPDRS III for motor symptoms, NMSS for non-motor symptoms, PDSS for sleep-specific dysfunction) and two nights of wearable PSG recordings. Postoperatively, DBS parameters will be optimized at 1 month for motor symptom control. Follow-up evaluations at 3, 6, and 12 months post-operation include in-hospital PSG and local field potential (LFP) recordings: Night 1 captures data under DBS-OFF conditions, followed by Night 2 with DBS-ON under optimized programming, alongside repeated clinical assessments. Sleep architecture (NREM/REM stages, arousal indices,atonia) and STN-LFPs will be analyzed and correlated with clinical outcomes. Machine learning models will identify LFP biomarkers predictive of sleep improvement to inform closed-loop stimulation strategies. Based on the machine learning results, we will investigate the adaptive algorithm and validate its effectiveness in the second phase. Adaptive stimulation will be administered for one month, followed by two consecutive nights of polysomnography (PSG) monitoring and Parkinson's Disease Sleep Scale (PDSS) assessments at the study interval endpoint. Subsequently, patients will undergo routine open-loop stimulation for one month, with two additional consecutive nights of PSG monitoring and PDSS evaluations conducted upon completion of this phase. Sleep improvement outcomes will be systematically compared between the two stimulation modalities.
- Being tested
- Deep Brain Stimulation
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationProcedure or surgery
Deep Brain Stimulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of REM sleep stage
Sleep fragmentation frequency and duration will be measured using PSG
Measured: 12 months
Subjective Sleep Quality
Change in subjective sleep quality will be measured between the different conditions. The measure will be captured using the Parkinson's disease sleep scale, PDSS.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 Sep 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (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.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yuqing Zhang, Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914466
- Sponsor's protocol ID
- 20250322
- Status last verified
- Mar 2025
- First submitted
- 30 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms and Clinical Applications of Deep Brain Stimulation for Modulating Sleep Dysregulation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06914466
- Acronym / sponsor ID
- 20250322
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 6 Apr 2025 (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.
Parkinson's disease (PD) is a prevalent neurodegenerative disorder characterized by both motor and non-motor symptoms. Subthalamic nucleus (STN) deep brain stimulation (DBS) effectively alleviates motor symptoms; however, non-motor symptoms such as sleep disorders significantly impair patients' quality of life. While preliminary evidence suggests DBS may improve sleep, the underlying neural mechanisms and long-term effects on sleep regulation remain poorly elucidated. This study employs a wearable polysomnography (PSG) device to investigate how STN-DBS modulates sleep architecture, local field potentials (LFPs), and clinical outcomes in PD patients. We hypothesize that STN-DBS contributes to both the regulation and disruption of normal sleep behavior. By synchronizing PSG with STN-LFP recordings under DBS-ON and DBS-OFF conditions, we aim to decode sleep stages using STN-LFPs, characterize PD-specific sleep abnormalities (e.g., sleep architecture, atonia), and analyze DBS-induced LFP changes and their correlations with clinical efficacy. According to the above data, the sleep stage characteristics were decoded, and the algorithm was used to determine the optimal clinical threshold current amplitude to improve sleep. Then, the patients will be given adaptive stimulation, and the sleep quality was monitored to verify its efficacy.This study will provide a neurophysiological foundation for developing closed-loop stimulation strategies targeting sleep dysfunction in PD.
Detailed description
This single-center longitudinal observational study will enroll 20 idiopathic Parkinson's disease (PD) patients with bilateral subthalamic nucleus (STN) deep brain stimulation (DBS) systems (Medtronic Percept™ PC) to evaluate the neurophysiological mechanisms of DBS in sleep regulation. Participants will undergo preoperative clinical assessments (MDS-UPDRS III for motor symptoms, NMSS for non-motor symptoms, PDSS for sleep-specific dysfunction) and two nights of wearable PSG recordings. Postoperatively, DBS parameters will be optimized at 1 month for motor symptom control. Follow-up evaluations at 3, 6, and 12 months post-operation include in-hospital PSG and local field potential (LFP) recordings: Night 1 captures data under DBS-OFF conditions, followed by Night 2 with DBS-ON under optimized programming, alongside repeated clinical assessments. Sleep architecture (NREM/REM stages, arousal indices,atonia) and STN-LFPs will be analyzed and correlated with clinical outcomes. Machine learning models will identify LFP biomarkers predictive of sleep improvement to inform closed-loop stimulation strategies. Based on the machine learning results, we will investigate the adaptive algorithm and validate its effectiveness in the second phase. Adaptive stimulation will be administered for one month, followed by two consecutive nights of polysomnography (PSG) monitoring and Parkinson's Disease Sleep Scale (PDSS) assessments at the study interval endpoint. Subsequently, patients will undergo routine open-loop stimulation for one month, with two additional consecutive nights of PSG monitoring and PDSS evaluations conducted upon completion of this phase. Sleep improvement outcomes will be systematically compared between the two stimulation modalities.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's Disease who 2.underwent bilateral STN-DBS(Medtronic Percept™ PC) and consent to participate in the sleep study.
Key inclusion criteria (3 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.
- Patients who underwent bilateral STN-DBS(Medtronic Percept™ PC)
- Patients who can cooperate with the completion of postoperative follow-up and clinical evaluation.
Key exclusion criteria (6 listed)
- Patients who underwent 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, or 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 |
|---|---|---|
| Deep Brain StimulationDeep Brain Stimulation | Procedure or surgery | – |
Primary outcome
Duration of REM sleep stage
Time frame: 12 months
Sleep fragmentation frequency and duration will be measured using PSG
Subjective Sleep Quality
Time frame: 12 months
Change in subjective sleep quality will be measured between the different conditions. The measure will be captured using the Parkinson's disease sleep scale, PDSS.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
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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.
yuqing Zhang study chair
Xuanwu Hospital, Beijing
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 Parkinson's Disease and Parkinsonism, run by Xuanwu Hospital, Beijing 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 3 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: looking for participants now, as of the sponsor's last update on 6 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yuqing Zhang (010-83922345, yuqzhang@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of REM sleep stage (time frame: 12 months). 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 6 Apr 2025.