Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 45 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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.
Study sites (1)
CO
- University of Colorado · Aurora, CO 80045More trials in Aurora