NCT07808346 Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
| NCT ID | NCT07808346 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Parkinson's Disease (PD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2026-12-01 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 18 participants in total. It began in 2026-12-01 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an interventional study of a cohort of patients with PD treated with DBS, and already utilizing adaptive DBS (dual threshold mode). In Aim 1, we will obtain baseline sleep and basal ganglia physiology data to inform aDBS parameter changes. Aim 2 involves 15 nights of in-home monitoring of subjective and objective sleep quality, during which participants will use 3 different sleep-tailored aDBS settings at night only. Participant preference among these 3 settings will determined the 'optimized sleep-tailored aDBS mode'. Participants will undergo repeat polysomnography, while in the optimized sleep-tailored aDBS mode, to compare aDBS behavior and sleep architecture to the baseline (Aim 1) sleep study.
Eligibility Criteria
Inclusion Criteria: * Adult patients, in the age range of 45 to 75 years (inclusive) * Have a smart phone and be willing and able to download the app required for the Waveband and SEMA3 * Are able to use the Waveband app * Diagnosis of idiopathic PD and treatment with STN or GPi DBS using the Medtronic system, including SenSight (model B33005 or B33015) leads and Percept RC (model B35300) implanted pulse generator * Hoehn and Yahr stage 2-3 (on medication, on DBS) at the time of enrollment * Taking unchanged doses of antiparkinsonian medications for at least 4 weeks prior to study enrollment. * Stable and optimized (for motor symptom control) DBS therapy settings, using adaptive DBS in the dual threshold mode. 'Stable and optimized 'will be defined by the following: 1) no changes made to DBS stimulation parameters within the last 30 days, and 2) improvement of PD motor symptoms, as determined by the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) part III, of at least 30% between the stimulation off and on conditions. Exclusion Criteria: * Clinical diagnosis of dementia * Current or recent (within the past 30 days) use a sedative-hypnotic drug (including medications known to affect SPs or SWs such as benzodiazepines40) * Participants who fulfill criteria for or carry a diagnosis of a circadian sleep-wake disorder as defined by the International Classification of Sleep Disorders, 3rd Edition41 * Shift workers * Presence of any other condition that, in the opinion of the investigator, will preclude the participant from successfully or safely completing study procedures.
Contact & Investigator
Neurology Recruitment Partner Neurology Recruitment Partner
✉ Neuroresearch@cuanschutz.edu📞 3037244644
Frequently Asked Questions
Who can join the NCT07808346 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying Parkinson's Disease (PD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07808346 currently recruiting?
Yes, NCT07808346 is actively recruiting participants. Contact the research team at Neuroresearch@cuanschutz.edu for enrollment information.
Where is the NCT07808346 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT07808346 clinical trial?
NCT07808346 is sponsored by University of Colorado, Denver. The trial plans to enroll 18 participants.
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