Parkinson DiseaseDREAMS-PDNCT07110376
Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease
A study testing Nighttime Deep Brain Stimulation with Varying Amplitude Settings in people with Parkinson Disease, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This study employs an exploratory, prospective, single center, naturalistic clinical trial design with a randomized crossover intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Nighttime Deep Brain Stimulation with Varying Amplitude Settings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2025to 31 Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female > 18 years of age
- Diagnosed with idiopathic Parkinson Disease
- Have bilateral implantation of Medtronic's PerceptTM PC (Medtronic Neurological Division, Minneapolis, MN, USA) Deep Brain Stimulation (DBS) system targeting the subthalamic nucleus (STN) and have had their stimulation settings optimized for a minimum of three months
- Report a response score of one or greater on question 1.7 of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I;
- Demonstrate ability to ambulate independently;
- Be capable of providing informed consent;
- If taking sleep-supporting medications, dosing must be stable for at least 30 days
Who cannot join
- Presence of neurological diseases other than Parkinson Disease, such as stroke or multiple sclerosis
- Active sleep disorders, including narcolepsy, moderate to severe (Apnea-Hypopnea Index>=15) untreated sleep apnea, uncontrolled restless legs syndrome
- Cognitive impairment meeting the criteria for dementia as per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), based on formal neuropsychological evaluation
- Ongoing alcohol or substance abuse; Working night shifts or irregular work hours
- The main concern for vulnerable subjects will be for the possibility of reduced decision-making capacity. For this we intend to exclude individuals who have a diagnosis of dementia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 441950001
Project Manager, 216-372-2867, beukemm@ccf.org
Saar Anis, MD, 216 678-8896, ANISS2@ccf.org
About this study
Official title: Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease - The DREAMS-PD Study
This study employs an exploratory, prospective, single center, naturalistic clinical trial design with a randomized crossover intervention.
Read the detailed description
Deep brain stimulation (DBS) stands as an established and robust treatment for various motor symptoms in patients with Parkinson's disease (PWP). While it has shown promise in ameliorating non-motor symptoms, the mechanisms underlying these improvements remain poorly understood. A significant forthcoming shift in the DBS landscape is the transition towards closed-loop or "adaptive DBS" (aDBS). This approach relies on expanding knowledge of basal ganglia electrophysiology and its correlation with motor symptoms. Augmented beta frequency oscillations (13-35 Hz) in local field potentials (LFP) from the basal ganglia is correlated with severity of the motor systems bradykinesia/rigidity and serve as an electrophysiological biomarker for clinical state. Essentially, aDBS aims to modulate stimulation in response to neural state, offering more precise symptom control.
Sleep disturbances are a prevalent symptom in PWP, affecting a vast majority of patients, and serve as a significant non-motor contributor to quality of life. While DBS has demonstrated benefits in enhancing sleep efficiency and architecture, the mechanisms by which this might occur, as well as the optimal stimulation parameters for treating sleep dysfunctions are unknown. Sleep is associated with a dramatic change in subcortical neural activity compared to the wake state, with decreased beta activity, which could serve as a neurophysiological biomarker for the sleep state. Since beta frequencies are a common target for adaptive DBS studies in PD, addressing sleep-induced reductions in beta activity will be crucial for future algorithm development. Incorrectly interpreting sleep as the "medication-on" state may result in an adaptive algorithm providing the patient with non-optimal stimulation amplitudes that may adversely affect sleep.
There is an urgent need to identify the dose-response curve regarding how stimulation affects sleep quality and neurophysiology. Our primary objective is to address this knowledge gap by obtaining a comprehensive understanding of the subcortical neural signatures of sleep, and their correlation with sleep outcomes under different stimulation currents. This will ultimately enable us to establish the control policy for adaptive control of stimulation amplitude (current). Our central hypothesis is that different stimulation currents will elicit distinct effects on sleep subcortical neural signatures and sleep quality.
- Conditions
- Parkinson Disease
- Being tested
- Nighttime Deep Brain Stimulation with Varying Amplitude Settings
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nighttime Deep Brain Stimulation with Varying Amplitude SettingsOther
Also called Nocturnal DBS Amplitude Modulation, DBS Sleep Modulation Protocol, 0%, 50%, 100% DBS Night Settings
Participants will undergo three different nighttime-only Deep Brain Stimulation (DBS) settings in a randomized crossover design: 0% amplitude (stimulation off), 50% amplitude of their optimal clinical DBS settings, and full clinical DBS settings (100%). Each setting is applied for two weeks during sleep, over a total six-week home monitoring period. The intervention is designed to assess how varying levels of subthalamic nucleus DBS influence sleep quality and neural oscillatory activity. Only nighttime DBS settings are modified; daytime settings remain unchanged.
| Study group | Role | What they receive |
|---|---|---|
| Evaluate the Impact of Deep Brain Stimulation Settings on Sleep | Experimental | Participants with Parkinson's disease implanted with a Medtronic Percept™ deep brain stimulation (DBS) system will undergo a 6-week in-home monitoring protocol. Each participant will be exposed to three different nighttime-only DBS stimulation settings in a randomized 2-week crossover design: (1) no stimulation (0% amplitude), (2) reduced stimulation (50% amplitude), and (3) optimal clinical stimulation. Sleep metrics will be collected nightly using the Dreem Headband wearable electroencephalogram (EEG) device. One night of polysomnography will also be conducted to validate the wearable. Subcortical local field potentials (LFPs) from the subthalamic nucleus will be recorded to assess band power and coherence during different stimulation settings and sleep stages. The study aims to evaluate the effect of DBS settings on sleep efficiency, spectral features of neural activity, and their correlation. Receives: Other: Nighttime Deep Brain Stimulation with Varying Amplitude Settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate differences in sleep efficiency (SE) among different stimulation settings.
Sleep efficiency will be calculated as: (total sleep time ÷ total time in bed) × 100, using nightly data collected via the Dreem Headband. The mean SE for each 2-week stimulation setting (0%, 50%, 100% amplitude) will be compared within subjects using crossover analysis.
Measured: At the end of each 2-week stimulation period (over 6 weeks total)
Secondary outcomes (7)
Average Nightly Beta Band Power
Average beta band power will be derived from subthalamic nucleus local field potentials recorded via the Medtronic Percept™ system.
Measured: At the end of each 2-week stimulation period (over 6 weeks total)
Correlation Between Sleep Efficiency and Beta Band Power
The correlation between sleep efficiency (measured by Dreem Headband) and beta band power (recorded from DBS electrodes) will be evaluated. Analyses will include full-night averages and specific sleep stages (N1/N2, N3).
Measured: Over each night during the 6-week study period
Correlation of Wake After Sleep Onset (WASO) with Beta Band Power
Wake after sleep onset (WASO) will be analyzed in relation to Deep Brain Stimulation (DBS) band power. Relationships will be examined across each stimulation condition and averaged over the study.
Measured: Across 6-week study period and at the end of each 2-week stimulation phase
Coherence Across Deep Brain Stimulation Amplitude Settings
Coherence between left and right subthalamic nucleus (STN) will be calculated. Comparisons will be made across the three stimulation settings
Measured: At the end of each 2-week stimulation period (over 6 weeks total)
Correlation of sleep fragmentation index with Beta Band Power
Sleep fragmentation index will be analyzed in relation to Deep Brain Stimulation (DBS) band power. Relationships will be examined across each stimulation condition and averaged over the study.
Measured: Across 6-week study period and at the end of each 2-week stimulation phase
Correlation of Pittsburgh Sleep Quality Index (PSQI) with Beta Band Power
Pittsburgh Sleep Quality Index (PSQI) will be analyzed in relation to Deep Brain Stimulation (DBS) band power. Relationships will be examined across each stimulation condition and averaged over the study.
Measured: Across 6-week study period and at the end of each 2-week stimulation phase
Correlation of and Epworth Sleepiness Scale (ESS) with Beta Band Power
Epworth Sleepiness Scale (ESS) will be analyzed in relation to Deep Brain Stimulation (DBS) band power. Relationships will be examined across each stimulation condition and averaged over the study.
Measured: Across 6-week study period and at the end of each 2-week stimulation phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start22 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (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.
- More trials run by The Cleveland ClinicThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- American Parkinson's Disease Association, Inc, Beacon Biosignals
- Responsible party
- Principal investigator, James Liao, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110376
- Sponsor's protocol ID
- 25-323 DREAMS-PD
- Acronym
- DREAMS-PD
- Status last verified
- Oct 2025
- First submitted
- 28 Jul 2025
- Last updated
- 28 Aug 2026
- 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 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease - The DREAMS-PD Study
- ClinicalTrials.gov ID
- NCT07110376
- Acronym / sponsor ID
- DREAMS-PD / 25-323 DREAMS-PD
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- American Parkinson's Disease Association, Inc, Beacon Biosignals
- Study start
- 22 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 7 Aug 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.
This study employs an exploratory, prospective, single center, naturalistic clinical trial design with a randomized crossover intervention.
Detailed description
Deep brain stimulation (DBS) stands as an established and robust treatment for various motor symptoms in patients with Parkinson's disease (PWP). While it has shown promise in ameliorating non-motor symptoms, the mechanisms underlying these improvements remain poorly understood. A significant forthcoming shift in the DBS landscape is the transition towards closed-loop or "adaptive DBS" (aDBS). This approach relies on expanding knowledge of basal ganglia electrophysiology and its correlation with motor symptoms. Augmented beta frequency oscillations (13-35 Hz) in local field potentials (LFP) from the basal ganglia is correlated with severity of the motor systems bradykinesia/rigidity and serve as an electrophysiological biomarker for clinical state. Essentially, aDBS aims to modulate stimulation in response to neural state, offering more precise symptom control.
Sleep disturbances are a prevalent symptom in PWP, affecting a vast majority of patients, and serve as a significant non-motor contributor to quality of life. While DBS has demonstrated benefits in enhancing sleep efficiency and architecture, the mechanisms by which this might occur, as well as the optimal stimulation parameters for treating sleep dysfunctions are unknown. Sleep is associated with a dramatic change in subcortical neural activity compared to the wake state, with decreased beta activity, which could serve as a neurophysiological biomarker for the sleep state. Since beta frequencies are a common target for adaptive DBS studies in PD, addressing sleep-induced reductions in beta activity will be crucial for future algorithm development. Incorrectly interpreting sleep as the "medication-on" state may result in an adaptive algorithm providing the patient with non-optimal stimulation amplitudes that may adversely affect sleep.
There is an urgent need to identify the dose-response curve regarding how stimulation affects sleep quality and neurophysiology. Our primary objective is to address this knowledge gap by obtaining a comprehensive understanding of the subcortical neural signatures of sleep, and their correlation with sleep outcomes under different stimulation currents. This will ultimately enable us to establish the control policy for adaptive control of stimulation amplitude (current). Our central hypothesis is that different stimulation currents will elicit distinct effects on sleep subcortical neural signatures and sleep quality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluate the Impact of Deep Brain Stimulation Settings on Sleep | Experimental | Other: Nighttime Deep Brain Stimulation with Varying Amplitude SettingsParticipants with Parkinson's disease implanted with a Medtronic Percept™ deep brain stimulation (DBS) system will undergo a 6-week in-home monitoring protocol. Each participant will be exposed to three different nighttime-only DBS stimulation settings in a randomized 2-week crossover design: (1) no stimulation (0% amplitude), (2) reduced stimulation (50% amplitude), and (3) optimal clinical stimulation. Sleep metrics will be collected nightly using the Dreem Headband wearable electroencephalogram (EEG) device. One night of polysomnography will also be conducted to validate the wearable. Subcortical local field potentials (LFPs) from the subthalamic nucleus will be recorded to assess band power and coherence during different stimulation settings and sleep stages. The study aims to evaluate the effect of DBS settings on sleep efficiency, spectral features of neural activity, and their correlation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female > 18 years of age
- Diagnosed with idiopathic Parkinson Disease
- Have bilateral implantation of Medtronic's PerceptTM PC (Medtronic Neurological Division, Minneapolis, MN, USA) Deep Brain Stimulation (DBS) system targeting the subthalamic nucleus (STN) and have had their stimulation settings optimized for a minimum of three months
- Report a response score of one or greater on question 1.7 of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I;
- Demonstrate ability to ambulate independently;
Key exclusion criteria (5 listed)
- Presence of neurological diseases other than Parkinson Disease, such as stroke or multiple sclerosis
- Active sleep disorders, including narcolepsy, moderate to severe (Apnea-Hypopnea Index>=15) untreated sleep apnea, uncontrolled restless legs syndrome
- Cognitive impairment meeting the criteria for dementia as per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), based on formal neuropsychological evaluation
- Ongoing alcohol or substance abuse; Working night shifts or irregular work hours
- The main concern for vulnerable subjects will be for the possibility of reduced decision-making capacity. For this we intend to exclude individuals who have a diagnosis of dementia.
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 |
|---|---|---|
| Nighttime Deep Brain Stimulation with Varying Amplitude SettingsAlso: Nocturnal DBS Amplitude Modulation, DBS Sleep Modulation Protocol, 0%, 50%, 100% DBS Night SettingsParticipants will undergo three different nighttime-only Deep Brain Stimulation (DBS) settings in a randomized crossover design: 0% amplitude (stimulation off), 50% amplitude of their optimal clinical DBS settings, and full clinical DBS settings (100%). Each setting is applied for two weeks during sleep, over a total six-week home monitoring period. The intervention is designed to assess how varying levels of subthalamic nucleus DBS influence sleep quality and neural oscillatory activity. Only nighttime DBS settings are modified; daytime settings remain unchanged. | Other | Evaluate the Impact of Deep Brain Stimulation Settings on Sleep |
Primary outcome
To demonstrate differences in sleep efficiency (SE) among different stimulation settings.
Time frame: At the end of each 2-week stimulation period (over 6 weeks total)
Sleep efficiency will be calculated as: (total sleep time ÷ total time in bed) × 100, using nightly data collected via the Dreem Headband. The mean SE for each 2-week stimulation setting (0%, 50%, 100% amplitude) will be compared within subjects using crossover analysis.
7 secondary outcomes
Average Nightly Beta Band Power
Time frame: At the end of each 2-week stimulation period (over 6 weeks total)
Correlation Between Sleep Efficiency and Beta Band Power
Time frame: Over each night during the 6-week study period
Correlation of Wake After Sleep Onset (WASO) with Beta Band Power
Time frame: Across 6-week study period and at the end of each 2-week stimulation phase
Coherence Across Deep Brain Stimulation Amplitude Settings
Time frame: At the end of each 2-week stimulation period (over 6 weeks total)
Correlation of sleep fragmentation index with Beta Band Power
Time frame: Across 6-week study period and at the end of each 2-week stimulation phase
Correlation of Pittsburgh Sleep Quality Index (PSQI) with Beta Band Power
Time frame: Across 6-week study period and at the end of each 2-week stimulation phase
Correlation of and Epworth Sleepiness Scale (ESS) with Beta Band Power
Time frame: Across 6-week study period and at the end of each 2-week stimulation phase
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 28 Aug 2026.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nighttime Deep Brain Stimulation with Varying Amplitude Settings in people with Parkinson Disease, run by The Cleveland Clinic 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 7 inclusion and 5 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 28 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?
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 Saar Anis, MD (216 678-8896, ANISS2@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate differences in sleep efficiency (SE) among different stimulation settings. (time frame: At the end of each 2-week stimulation period (over 6 weeks total)). 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 28 Aug 2026.