Parkinson's DiseaseNCT05070013
Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease (Aim 2)
A study testing Deep Brain Stimulation in people with Parkinson's Disease and Sleep Fragmentation, run by University of Nebraska at 2 sites in United States.
Trial summary
Parkinson's Disease (PD) is the second most common of the age-related neurodegenerative disorders, affecting over 1,900 adults per 100,000 over the age of 80 in the US. The prevalence of sleep dysfunction in PD is estimated at nearly 80-90% which includes sleep fragmentation, insomnia, rapid eye movement (REM or dream… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson's Disease, Sleep Fragmentation
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Nov 2021to 30 Jun 2026
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Diagnosis of Idiopathic Parkinson's disease (PD) with motor symptoms present for a minimum of 4 years
- Severe motor symptoms (e.g., motor fluctuations, dyskinesia, tremor, bradykinesia, rigidity) despite optimized medical therapy, that warrant surgical implantation of deep brain stimulation (DBS), according to standard clinical criteria
- Unified Parkinson's Disease Rating Scale (UPDRS-III) score off medication 20 to 80, and improvement of at least 30% in UPDRS-III score on medications, or tremor-dominant PD (score >/= 2 on UPDRS-III tremor sub-score) or tremor in addition to other motor symptoms that are treatment-resistant and result in significant functional disability
- Appropriate trials of oral PD medications resulting in inadequate relief of motor symptoms as determined by a movement disorders neurologist, and stable dose of anti-PD medications for 30 days prior to study enrollment
- Requested and approved for subthalamic nucleus deep brain stimulation surgery (STN DBS) by study site Multi-Disciplinary Movement Disorders Patient Care Conference
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- Absence of abnormalities on brain magnetic resonance imaging (MRI) scan suggestive of an alternate diagnosis or serving as a contraindication to surgery
- Absence of significant cognitive deficits or significant depression (Beck Depression Inventory-II, BDI-II, score > 20) on formal Neuropsychological Testing
- Age 18 to 80 years (19 to 80 years in Nebraska)
- Able to conduct follow up neurological care exclusively at study site for duration of the RC+S INS neurostimulator device lifespan (9 years)
Who cannot join
- Any medical condition considered to elevate risk for surgical complications, such as coagulopathy,, uncontrolled hypertension, history of seizures, heart disease, inability to undergo general anesthesia, or anticoagulant medications that cannot be safely discontinued for perioperative period
- Pregnancy (women of child-bearing potential must have a negative urine pregnancy test prior to surgical procedures)
- Significant untreated depression (Beck Depression Inventory-II, BDI-II > 20 or Geriatric Depression Scale, GDS, score > 8)
- Personality or mood disorder symptoms that investigators believe will interfere with study requirements
- Required ongoing treatment with electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (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
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- Prior intracranial surgery
- History or active, drug or alcohol abuse
- Meets criteria for Parkinson's disease (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
- Restless Leg Syndrome
- Obstructive Sleep Apnea
- Inability to perform the recharge process necessary to use the RC+S brain stimulation system
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Dulce Maroni, PhD, 402-836-9751, dmaroni@unmc.edu
Andrew Schnaubelt, PhD, 402-559-4846, andy.schnaubelt@unmc.edu
- Recruiting
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19106
NIda Firdous, MD, 215-829-6720, nida.firdous@pennmedicine.upenn.edu
Marie Kerr, CCRP, 215-829-6720, marie.kerr@pennmedicine.upenn.edu
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 the second most common of the age-related neurodegenerative disorders, affecting over 1,900 adults per 100,000 over the age of 80 in the US. The prevalence of sleep dysfunction in PD is estimated at nearly 80-90% which includes sleep fragmentation, insomnia, rapid eye movement (REM or dream sleep) Sleep Behavior Disorder (RBD), Restless legs syndrome (RLS), periodic limb movement, excessive daytime sleepiness, and sleep apnea. Sleep is vital to homeostasis, cognition, and nervous system repair. The dysfunctional sleep accompanying PD adversely affects both motor and non-motor symptoms, resulting in diminished quality of life for both patients and caregivers, including impairments in mood and behavior, and increased morbidity and mortality. Knowledge of sleep phenomenology and pathology in humans has largely been informed by analysis of non-invasive scalp electroencephalogram (EEG), and despite the profound importance of sleep, the underlying neural circuits important for controlling sleep and wakefulness in humans remain poorly understood.
This study assesses whether adaptive stimulation of the Subthalamic Nucleus (STN) drives changes in sleep episode maintenance and improves sleep quality. Participants are adults with PD who experience inadequate motor symptom relief, and who have been offered implantation of a deep brain stimulator system targeting STN for the treatment of motor symptoms (standard-of-care). Prior to surgery, participant sleep patterns will be assessed with questionnaires and monitored with a non-invasive watch-like device. Approximately four months after implantation surgery, participants will each receive 2 1-week deep brain stimulation (DBS) treatments and 1 1-week control session with no DBS in random order. Sleep patterns will again be monitored during the treatments and compared to the patterns before surgery.
Read the detailed description
IIn previous studies, investigators examined the use of local field potentials (LFP) recorded from Subthalamic Nucleus (STN) - Deep brain stimulation (DBS) electrodes to identify unique spectral patterns in STN oscillatory activity that correlate with distinct sleep cycles. This offered insight into sleep dysregulation and supported the idea that biomarkers from STN-recorded LFP could be used to identify specific sleep stages. Data from this study directly informed the development and optimization of an adaptive stimulation algorithm.
The current study will assess the efficacy of the adaptive stimulation algorithm and will test the working hypothesis that modulation of STN during nighttime sleep will normalize sleep behavior by offsetting aberrant signaling in the sleep network. Investigators will use subjective assessments, 3-week actigraphy, and nocturnal polysomnogram (PSG), in 20 Parkinson's Disease (PD) participants for 3-weeks prior to surgery and again 4-months after DBS implantation during the interventions. The time between surgery and the start of interventions allows DBS and medication to be therapeutically optimized for PD motor symptoms. Investigators will compare chronic open-loop stimulation to adaptive stimulation, and to a no-stimulation control group. All participants will experience each of the 3 interventions in random order and be blinded to the type of intervention received.
The study hopes to validate a therapeutic intervention for the burdensome non-motor symptom of sleep dysfunction in PD, and to fill a critical gap in our understanding of the contribution of STN-DBS to ameliorating sleep-wake disturbances in PD. The acquisition of these data will improve the understanding of the role of basal ganglia, specifically STN, in sleep homeostasis in PD. It is expected that STN-DBS will improve sleep-wake parameters in both the PSG and actigraphy recordings but that adaptive stimulation, targeted at sleep-stage biomarkers, will further optimize sleep and alleviate this non-motor burden in PD. Specifically, investigators predict that adaptive more so than chronic open-loop STN-DBS during sleep will decrease non-consolidated sleep, reduce the frequency of awakenings, increase the percentage time spent in REM sleep, reduce daytime sleepiness, and increase subjective experience of restfulness and sleep quality.
- Conditions
- Parkinson's Disease, Sleep Fragmentation
- Being tested
- Deep Brain 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.
Deep Brain StimulationDevice
All participants will undergo three 1-week interventions of stimulation during nighttime sleep over the course of three consecutive weeks of in-home sleep: adaptive stimulation, open-loop stimulation and no stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Deep Brain Stimulation | Experimental | Participants will be given adaptive deep brain stimulation (DBS) during one week of at-home night sleep. Receives: Device: Deep Brain Stimulation |
| Open-loop Deep Brain Stimulation | Active comparator | Participants will be given open-loop deep brain stimulation (DBS) (standard clinical stimulation therapy based on (DBS) programming for the treatment of motor symptoms) during one week of at-home night sleep. Receives: Device: Deep Brain Stimulation |
| No Deep Brain Stimulation | No intervention | Deep brain stimulation (DBS) is turned off (control) during one week of at-home night sleep. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency - Frequency
Sleep fragmentation frequency will be measured using FDA-approved wrist-based Actigraphy (ActiWatch Spectrum Pro). Comparisons will be made between baseline and each of the interventions.
Measured: Baseline (days 1 - 21 before surgery) and intervention (approximately days 144 - 172)
Sleep Efficiency - Duration
Sleep fragmentation duration will be measured using FDA-approved wrist-based Actigraphy (ActiWatch Spectrum Pro). Comparisons will be made between baseline and each of the interventions.
Measured: Baseline (days 1 - 21 before surgery) and intervention (approximately days 144 - 172)
Subjective Sleep Quality
Subjective sleep quality will be assessed using the Pittsburgh Sleep Diary. Comparisons will be made between baseline and each of the interventions.
Measured: Baseline (days 1 - 21 before surgery) and intervention (approximately days 144 - 172)
Secondary outcomes (1)
Duration of REM Sleep Stage
Change in the duration of rapid eye movement (REM or dream) stage sleep will be measured and compared between the 3 stimulation interventions. An artificial neural network, Dreem 3, will be used to identify sleep stage and duration.
Measured: During intervention (approximately days 144 - 172)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start18 Nov 2021
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will experience all 3 DBS stimulation interventions (one condition per week, 3 consecutive weeks): adaptive stimulation, open-loop stimulation (standard clinical stimulation therapy) and no stimulation (control). The order of stimulation conditions is randomly assigned.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aviva Abosch, MD, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070013
- Sponsor's protocol ID
- 0577-21-FB
- Other IDs
- 1UH3NS113769
- Status last verified
- May 2025
- First submitted
- 28 Sep 2021
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All individual participant data (IPD) that underlie results in a publication will be available to other researchers through the Data Archive for the BRAIN Initiative (DABI) data sharing portal.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. 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
- NCT05070013
- Acronym / sponsor ID
- 0577-21-FB
- Conditions
- Parkinson's Disease, Sleep Fragmentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 6 Oct 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.
Parkinson's Disease (PD) is the second most common of the age-related neurodegenerative disorders, affecting over 1,900 adults per 100,000 over the age of 80 in the US. The prevalence of sleep dysfunction in PD is estimated at nearly 80-90% which includes sleep fragmentation, insomnia, rapid eye movement (REM or dream sleep) Sleep Behavior Disorder (RBD), Restless legs syndrome (RLS), periodic limb movement, excessive daytime sleepiness, and sleep apnea. Sleep is vital to homeostasis, cognition, and nervous system repair. The dysfunctional sleep accompanying PD adversely affects both motor and non-motor symptoms, resulting in diminished quality of life for both patients and caregivers, including impairments in mood and behavior, and increased morbidity and mortality. Knowledge of sleep phenomenology and pathology in humans has largely been informed by analysis of non-invasive scalp electroencephalogram (EEG), and despite the profound importance of sleep, the underlying neural circuits important for controlling sleep and wakefulness in humans remain poorly understood.
This study assesses whether adaptive stimulation of the Subthalamic Nucleus (STN) drives changes in sleep episode maintenance and improves sleep quality. Participants are adults with PD who experience inadequate motor symptom relief, and who have been offered implantation of a deep brain stimulator system targeting STN for the treatment of motor symptoms (standard-of-care). Prior to surgery, participant sleep patterns will be assessed with questionnaires and monitored with a non-invasive watch-like device. Approximately four months after implantation surgery, participants will each receive 2 1-week deep brain stimulation (DBS) treatments and 1 1-week control session with no DBS in random order. Sleep patterns will again be monitored during the treatments and compared to the patterns before surgery.
Detailed description
IIn previous studies, investigators examined the use of local field potentials (LFP) recorded from Subthalamic Nucleus (STN) - Deep brain stimulation (DBS) electrodes to identify unique spectral patterns in STN oscillatory activity that correlate with distinct sleep cycles. This offered insight into sleep dysregulation and supported the idea that biomarkers from STN-recorded LFP could be used to identify specific sleep stages. Data from this study directly informed the development and optimization of an adaptive stimulation algorithm.
The current study will assess the efficacy of the adaptive stimulation algorithm and will test the working hypothesis that modulation of STN during nighttime sleep will normalize sleep behavior by offsetting aberrant signaling in the sleep network. Investigators will use subjective assessments, 3-week actigraphy, and nocturnal polysomnogram (PSG), in 20 Parkinson's Disease (PD) participants for 3-weeks prior to surgery and again 4-months after DBS implantation during the interventions. The time between surgery and the start of interventions allows DBS and medication to be therapeutically optimized for PD motor symptoms. Investigators will compare chronic open-loop stimulation to adaptive stimulation, and to a no-stimulation control group. All participants will experience each of the 3 interventions in random order and be blinded to the type of intervention received.
The study hopes to validate a therapeutic intervention for the burdensome non-motor symptom of sleep dysfunction in PD, and to fill a critical gap in our understanding of the contribution of STN-DBS to ameliorating sleep-wake disturbances in PD. The acquisition of these data will improve the understanding of the role of basal ganglia, specifically STN, in sleep homeostasis in PD. It is expected that STN-DBS will improve sleep-wake parameters in both the PSG and actigraphy recordings but that adaptive stimulation, targeted at sleep-stage biomarkers, will further optimize sleep and alleviate this non-motor burden in PD. Specifically, investigators predict that adaptive more so than chronic open-loop STN-DBS during sleep will decrease non-consolidated sleep, reduce the frequency of awakenings, increase the percentage time spent in REM sleep, reduce daytime sleepiness, and increase subjective experience of restfulness and sleep quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- All participants will experience all 3 DBS stimulation interventions (one condition per week, 3 consecutive weeks): adaptive stimulation, open-loop stimulation (standard clinical stimulation therapy) and no stimulation (control). The order of stimulation conditions is randomly assigned.
| Arm | Type | Receives |
|---|---|---|
| Adaptive Deep Brain Stimulation | Experimental | Device: Deep Brain StimulationParticipants will be given adaptive deep brain stimulation (DBS) during one week of at-home night sleep. |
| Open-loop Deep Brain Stimulation | Active comparator | Device: Deep Brain StimulationParticipants will be given open-loop deep brain stimulation (DBS) (standard clinical stimulation therapy based on (DBS) programming for the treatment of motor symptoms) during one week of at-home night sleep. |
| No Deep Brain Stimulation | No intervention | –Deep brain stimulation (DBS) is turned off (control) during one week of at-home night sleep. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent
- Diagnosis of Idiopathic Parkinson's disease (PD) with motor symptoms present for a minimum of 4 years
- Severe motor symptoms (e.g., motor fluctuations, dyskinesia, tremor, bradykinesia, rigidity) despite optimized medical therapy, that warrant surgical implantation of deep brain stimulation (DBS), according to standard clinical criteria
- Unified Parkinson's Disease Rating Scale (UPDRS-III) score off medication 20 to 80, and improvement of at least 30% in UPDRS-III score on medications, or tremor-dominant PD (score >/= 2 on UPDRS-III tremor sub-score) or tremor in addition to other motor symptoms that are treatment-resistant and result in significant functional disability
- Appropriate trials of oral PD medications resulting in inadequate relief of motor symptoms as determined by a movement disorders neurologist, and stable dose of anti-PD medications for 30 days prior to study enrollment
Key exclusion criteria (12 listed)
- Any medical condition considered to elevate risk for surgical complications, such as coagulopathy,, uncontrolled hypertension, history of seizures, heart disease, inability to undergo general anesthesia, or anticoagulant medications that cannot be safely discontinued for perioperative period
- Pregnancy (women of child-bearing potential must have a negative urine pregnancy test prior to surgical procedures)
- Significant untreated depression (Beck Depression Inventory-II, BDI-II > 20 or Geriatric Depression Scale, GDS, score > 8)
- Personality or mood disorder symptoms that investigators believe will interfere with study requirements
- Required ongoing treatment with electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (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 |
|---|---|---|
| Deep Brain StimulationAll participants will undergo three 1-week interventions of stimulation during nighttime sleep over the course of three consecutive weeks of in-home sleep: adaptive stimulation, open-loop stimulation and no stimulation. | Device | Adaptive Deep Brain Stimulation, Open-loop Deep Brain Stimulation |
Primary outcome
Sleep Efficiency - Frequency
Time frame: Baseline (days 1 - 21 before surgery) and intervention (approximately days 144 - 172)
Sleep fragmentation frequency will be measured using FDA-approved wrist-based Actigraphy (ActiWatch Spectrum Pro). Comparisons will be made between baseline and each of the interventions.
Sleep Efficiency - Duration
Time frame: Baseline (days 1 - 21 before surgery) and intervention (approximately days 144 - 172)
Sleep fragmentation duration will be measured using FDA-approved wrist-based Actigraphy (ActiWatch Spectrum Pro). Comparisons will be made between baseline and each of the interventions.
Subjective Sleep Quality
Time frame: Baseline (days 1 - 21 before surgery) and intervention (approximately days 144 - 172)
Subjective sleep quality will be assessed using the Pittsburgh Sleep Diary. Comparisons will be made between baseline and each of the interventions.
1 secondary outcome
Duration of REM Sleep Stage
Time frame: During intervention (approximately days 144 - 172)
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 22 Jul 2025.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) that underlie results in a publication will be available to other researchers through the Data Archive for the BRAIN Initiative (DABI) data sharing portal.
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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.
Aviva Abosch, MD, PhD principal investigator
University of Nebraska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Parkinson's Disease and Sleep Fragmentation, run by University of Nebraska at 2 sites 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 10 inclusion and 12 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 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Dulce Maroni, PhD (402-836-9751, dmaroni@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency - Frequency (time frame: Baseline (days 1 - 21 before surgery) and intervention (approximately days 144 - 172)). 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 22 Jul 2025.