Parkinson DiseaseNCT04620551
Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease
A study testing Sub-clinical stimulation in people with Parkinson Disease and Sleep Fragmentation, run by University of Nebraska at 1 site in United States.
Trial summary
Parkinson's disease (PD) is a neurodegenerative disorder that leads to both motor and non-motor symptoms. Therapies have been developed that effectively target the motor symptoms. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Parkinson Disease, Sleep Fragmentation
- What is being tested?
- Sub-clinical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2020to 30 Jun 2026
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent for this study
- Diagnosis of Idiopathic Parkinson's disease with motor symptoms that have been present for a minimum of 4 years
- Motor symptoms are severe enough, despite optimized medical therapy, to warrant surgical implantation of DBS
- UPDRS-III score off medication between 20 and 80, and an improvement in UPDRS-III score on medications of at least 30%, or patients with tremor-dominant PD (score >/= 2 on UPDRS-III tremor sub-score)-or tremor in addition to other motor symptoms-that is treatment-resistant and results in significant functional disability
- Appropriate trials of oral PD medications have resulted in inadequate relief of motor symptoms
- Absence of abnormalities on brain MRI suggestive of an alternate diagnosis or serving as a contraindication to surgery
- Absence of significant cognitive deficits or significant depression (BDI-II score > 20) on formal Neuropsychological Testing
- Age 21 - 80 years
Who cannot join
- Coagulopathy, uncontrolled hypertension, history of seizures, heart disease, inability to undergo general anesthesia
- Pregnancy
- Significant untreated depression (BDI-II score > 20)
- Personality or mood disorder symptoms that Study Personnel believe will interfere with study requirements
- Patients requiring ongoing treatment with ECT, rTMS, or diathermy
- Pre-existing implanted stimulation system (e.g., cochlear implant, cardiac pacemaker, defibrillator, neuro-stimulator for indication other than Parkinson's disease) or ferromagnetic metallic implant
Show all 10Show fewer
- Prior intracranial surgery
- History of, or active, drug or alcohol abuse
- Meets criteria for PD with Mild Cognitive Impairment (PD-MCI), as defined by Performance > 2 standard deviations below appropriate norms on tests from 2 or more of the following cognitive domains: Attention, Executive Function, Language, Memory, and Visuospatial Ability
- Patients with Restless Leg Syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease: An Investigation of STN LFP Biomarkers in Sleep Dysregulation and Repair
Parkinson's disease (PD) is a neurodegenerative disorder that leads to both motor and non-motor symptoms. Therapies have been developed that effectively target the motor symptoms. Non-motor symptoms are far more disabling for patients, precede the onset of motor symptoms by a decade, are more insidious in onset, have been less apparent to clinicians, and are less effectively treated. Sleep dysfunction is oftentimes the most burdensome of the non-motor symptoms. There are limited options for treating sleep dysfunction in PD, and the mainstay of therapy is the use of sedative-hypnotic drugs without addressing the underlying mechanisms. Patients with PD who demonstrate significant motor fluctuations and dyskinesia are considered for subthalamic nucleus (STN) deep brain stimulation (DBS) surgery. Several studies have reported that STN-DBS also provides benefit for sleep dysregulation. Additionally, local field potentials recorded from STN DBS electrodes implanted for the treatment of PD, have led to the identification of unique patterns in STN oscillatory activity that correlate with distinct sleep cycles, offering insight into sleep dysregulation. This proposal will leverage novel investigational DBS battery technology (RC+S Summit System; Medtronic) that allows the exploration of sleep biomarkers and prototyping of closed-loop stimulation algorithms, to test the hypothesis that STN contributes to the regulation and disruption of human sleep behavior and can be manipulated for therapeutic advantage. Specifically, in PD patients undergoing STN-DBS, the investigators will determine whether STN oscillations correlate with sleep stage transitions, then construct and evaluate sensing and adaptive stimulation paradigms that allow ongoing sleep-stage identification, and induce through adaptive stimulation an increase in duration of sleep stages associated with restorative sleep.
Read the detailed description
Although STN-DBS is routinely used to treat PD motor symptoms, several studies have reported that STN-DBS also provides benefit for sleep dysregulation through normalization of sleep architecture. In our previous work, using local field potentials (LFP) recorded from STN DBS electrodes implanted for the treatment of PD, unique spectral patterns in STN oscillatory activity were identified that correlated with distinct sleep cycles, offering insight into sleep dysregulation. These findings were used to construct an Artificial Neural Network (ANN) that can accurately predict sleep stage. Building on this work with the use of new DBS battery technology that allows exploration of potential biomarkers and prototyping of closed-loop algorithms, the investigators will test the hypothesis that STN-a highly interconnected node within the basal ganglia- contributes to the regulation and disruption of human sleep behavior and can be manipulated for therapeutic advantage.
This is the first part, Aim 1, of a two-part study. Investigators will enroll 20 subjects for Aim 1 of this study and 20 subjects for Aim 2, with 10 subjects enrolled at each clinical site for each aim (University of Nebraska Medical Center and Stanford University Medical Campus). In Aim 1, subjects will undergo standard-of-care STN DBS lead implantation surgery for the treatment of PD. They will return 3 weeks later to the in-patient Sleep Lab for 3 nights of STN LFP recordings with concurrent PSG, EMG, EOG, actigraphy, and video-EEG. The first two nights of recording will be used to establish a physiological sleep baseline for each patient. The third night of recording will involve sub-clinical thresholds of stimulation in all subjects, in an effort to favorably alter sleep-stage duration, so that NREM and REM-3 are prolonged. As a secondary outcome, subjects will be asked to complete a sleep questionnaire for all three nights, sleep during which stimulation occurred will be compared to the preceding two nights. Data collected during all three nights of recordings will be used to predict sleep stage identity from the LFPs recorded within STN, with the ground truth for each sleep stage provided by sleep-expert evaluated PSG. These data will also be used to identify the optimal sub-clinical threshold current amplitude and sleep-stage timing for adaptive stimulation to improve sleep. The stimulation algorithm developed in Aim 1 will be implemented in the second part of the study, Aim 2, to provide adaptive stimulation to subjects during nighttime sleep, over the course of 3 weeks of in-home sleep.
- Conditions
- Parkinson Disease, Sleep Fragmentation
- Being tested
- Sub-clinical stimulation
- Medical subject headings
- Parkinson Disease, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-clinical stimulationDevice
The third night of recording will involve sub-clinical thresholds of stimulation in all subjects.
| Study group | Role | What they receive |
|---|---|---|
| PD with DBS | Experimental | Patients with Parkinson's Disease who opt for DBS surgery and consent to participate in the sleep study. Receives: Device: Sub-clinical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep stage duration and transitions
We will measure pre- vs. post-stimulation impact on (1) LFP spectral composition; (2) sleep episode-specific change in duration; and (3) stimulation-induced latency to transition to next sleep episode.
Measured: Years 1-2
Secondary outcomes (1)
Sleep Quality
Study participants will complete the Pittsburgh Sleep Diary as a measure of self-reported sleep quality and sleep disturbance.
Measured: Years 1-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start21 Oct 2020
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aviva Abosch, MD, PhD, Study director, University of NebraskaCasey Halpern, MD, Principal investigator, Stanford UniversityClete Kushida, MD, PhD, Principal investigator, Stanford UniversityJohn Thompson, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620551
- Sponsor's protocol ID
- 0120-20-FB
- Status last verified
- Aug 2026
- First submitted
- 2 Nov 2020
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hirt L, Martini R, Tang S, Summers M, West L, Kushida C, Gliske SV, Maroni D, Nho Y, Halpern CH, Abosch A, Thompson JA. Shared Spectral Parameters Between EEG and Basal Ganglia LFP Distinguish Sleep-Specific Oscillations in Parkinson's Disease. Eur J Neurol. 2026 Sep;33(9):e70733. doi: 10.1111/ene.70733.
PubMed 42656011Das R, Gliske SV, West LC, Summers MO, Tang S, Hirt L, Maroni D, Halpern CH, Thompson JA, Kushida CA, Abosch A. Sleep macro-architecture in patients with Parkinson's disease does not change during the first night of neurostimulation in a pilot study. J Clin Sleep Med. 2024 Sep 1;20(9):1489-1496. doi: 10.5664/jcsm.11180.
PubMed 38652493West LC, Summers M, Tang S, Hirt L, Halpern CH, Maroni D, Das R, Gliske SV, Abosch A, Kushida CA, Thompson JA. Evaluation of consensus sleep stage scoring of dysregulated sleep in Parkinson's disease. Sleep Med. 2023 Jul;107:236-242. doi: 10.1016/j.sleep.2023.04.031. Epub 2023 May 18.
PubMed 37257366
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease: An Investigation of STN LFP Biomarkers in Sleep Dysregulation and Repair
- ClinicalTrials.gov ID
- NCT04620551
- Acronym / sponsor ID
- 0120-20-FB
- Conditions
- Parkinson Disease, Sleep Fragmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Stanford University, University of Pennsylvania, University of Colorado, Denver
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 9 Nov 2020 (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 neurodegenerative disorder that leads to both motor and non-motor symptoms. Therapies have been developed that effectively target the motor symptoms. Non-motor symptoms are far more disabling for patients, precede the onset of motor symptoms by a decade, are more insidious in onset, have been less apparent to clinicians, and are less effectively treated. Sleep dysfunction is oftentimes the most burdensome of the non-motor symptoms. There are limited options for treating sleep dysfunction in PD, and the mainstay of therapy is the use of sedative-hypnotic drugs without addressing the underlying mechanisms. Patients with PD who demonstrate significant motor fluctuations and dyskinesia are considered for subthalamic nucleus (STN) deep brain stimulation (DBS) surgery. Several studies have reported that STN-DBS also provides benefit for sleep dysregulation. Additionally, local field potentials recorded from STN DBS electrodes implanted for the treatment of PD, have led to the identification of unique patterns in STN oscillatory activity that correlate with distinct sleep cycles, offering insight into sleep dysregulation. This proposal will leverage novel investigational DBS battery technology (RC+S Summit System; Medtronic) that allows the exploration of sleep biomarkers and prototyping of closed-loop stimulation algorithms, to test the hypothesis that STN contributes to the regulation and disruption of human sleep behavior and can be manipulated for therapeutic advantage. Specifically, in PD patients undergoing STN-DBS, the investigators will determine whether STN oscillations correlate with sleep stage transitions, then construct and evaluate sensing and adaptive stimulation paradigms that allow ongoing sleep-stage identification, and induce through adaptive stimulation an increase in duration of sleep stages associated with restorative sleep.
Detailed description
Although STN-DBS is routinely used to treat PD motor symptoms, several studies have reported that STN-DBS also provides benefit for sleep dysregulation through normalization of sleep architecture. In our previous work, using local field potentials (LFP) recorded from STN DBS electrodes implanted for the treatment of PD, unique spectral patterns in STN oscillatory activity were identified that correlated with distinct sleep cycles, offering insight into sleep dysregulation. These findings were used to construct an Artificial Neural Network (ANN) that can accurately predict sleep stage. Building on this work with the use of new DBS battery technology that allows exploration of potential biomarkers and prototyping of closed-loop algorithms, the investigators will test the hypothesis that STN-a highly interconnected node within the basal ganglia- contributes to the regulation and disruption of human sleep behavior and can be manipulated for therapeutic advantage.
This is the first part, Aim 1, of a two-part study. Investigators will enroll 20 subjects for Aim 1 of this study and 20 subjects for Aim 2, with 10 subjects enrolled at each clinical site for each aim (University of Nebraska Medical Center and Stanford University Medical Campus). In Aim 1, subjects will undergo standard-of-care STN DBS lead implantation surgery for the treatment of PD. They will return 3 weeks later to the in-patient Sleep Lab for 3 nights of STN LFP recordings with concurrent PSG, EMG, EOG, actigraphy, and video-EEG. The first two nights of recording will be used to establish a physiological sleep baseline for each patient. The third night of recording will involve sub-clinical thresholds of stimulation in all subjects, in an effort to favorably alter sleep-stage duration, so that NREM and REM-3 are prolonged. As a secondary outcome, subjects will be asked to complete a sleep questionnaire for all three nights, sleep during which stimulation occurred will be compared to the preceding two nights. Data collected during all three nights of recordings will be used to predict sleep stage identity from the LFPs recorded within STN, with the ground truth for each sleep stage provided by sleep-expert evaluated PSG. These data will also be used to identify the optimal sub-clinical threshold current amplitude and sleep-stage timing for adaptive stimulation to improve sleep. The stimulation algorithm developed in Aim 1 will be implemented in the second part of the study, Aim 2, to provide adaptive stimulation to subjects during nighttime sleep, over the course of 3 weeks of in-home sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD with DBS | Experimental | Device: Sub-clinical stimulationPatients with Parkinson's Disease who opt for DBS surgery and consent to participate in the sleep study. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to provide informed consent for this study
- Diagnosis of Idiopathic Parkinson's disease with motor symptoms that have been present for a minimum of 4 years
- Motor symptoms are severe enough, despite optimized medical therapy, to warrant surgical implantation of DBS
- UPDRS-III score off medication between 20 and 80, and an improvement in UPDRS-III score on medications of at least 30%, or patients with tremor-dominant PD (score >/= 2 on UPDRS-III tremor sub-score)-or tremor in addition to other motor symptoms-that is treatment-resistant and results in significant functional disability
- Appropriate trials of oral PD medications have resulted in inadequate relief of motor symptoms
Key exclusion criteria (10 listed)
- Coagulopathy, uncontrolled hypertension, history of seizures, heart disease, inability to undergo general anesthesia
- Pregnancy
- Significant untreated depression (BDI-II score > 20)
- Personality or mood disorder symptoms that Study Personnel believe will interfere with study requirements
- Patients requiring ongoing treatment with ECT, rTMS, or diathermy
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 |
|---|---|---|
| Sub-clinical stimulationThe third night of recording will involve sub-clinical thresholds of stimulation in all subjects. | Device | PD with DBS |
Primary outcome
Sleep stage duration and transitions
Time frame: Years 1-2
We will measure pre- vs. post-stimulation impact on (1) LFP spectral composition; (2) sleep episode-specific change in duration; and (3) stimulation-induced latency to transition to next sleep episode.
1 secondary outcome
Sleep Quality
Time frame: Years 1-2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 42656011Hirt L, Martini R, Tang S, Summers M, West L, Kushida C, Gliske SV, Maroni D, Nho Y, Halpern CH, Abosch A, Thompson JA. Shared Spectral Parameters Between EEG and Basal Ganglia LFP Distinguish Sleep-Specific Oscillations in Parkinson's Disease. Eur J Neurol. 2026 Sep;33(9):e70733. doi: 10.1111/ene.70733.
- Derived from this study: PubMed 38652493Das R, Gliske SV, West LC, Summers MO, Tang S, Hirt L, Maroni D, Halpern CH, Thompson JA, Kushida CA, Abosch A. Sleep macro-architecture in patients with Parkinson's disease does not change during the first night of neurostimulation in a pilot study. J Clin Sleep Med. 2024 Sep 1;20(9):1489-1496. doi: 10.5664/jcsm.11180.
- Derived from this study: PubMed 37257366West LC, Summers M, Tang S, Hirt L, Halpern CH, Maroni D, Das R, Gliske SV, Abosch A, Kushida CA, Thompson JA. Evaluation of consensus sleep stage scoring of dysregulated sleep in Parkinson's disease. Sleep Med. 2023 Jul;107:236-242. doi: 10.1016/j.sleep.2023.04.031. Epub 2023 May 18.
- 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.
Aviva Abosch, MD, PhD study director
University of Nebraska
Casey Halpern, MD principal investigator
Stanford University
Clete Kushida, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sub-clinical stimulation in people with Parkinson Disease and Sleep Fragmentation, run by University of Nebraska at 1 site in United States.
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 8 inclusion and 10 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: finished, as of the sponsor's last update on 20 Aug 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep stage duration and transitions (time frame: Years 1-2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04620551, which also lists 3 linked publications.
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 20 Aug 2026.