Parkinson's Disease study: Adaptive DBS
Official title Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
ClinicalTrials.gov ID: NCT07808346
What this study is testing
- What it's testing
- This study aims to find the best deep brain stimulation setting for sleep and see how it affects sleep quality.
- Who it's for
- People with Parkinson's disease who already have a deep brain stimulation device and use its adaptive mode.
- What's involved
- Participants will wear sleep monitors at home for 15 nights while trying three different stimulation settings. They will also have a detailed sleep test in a lab to compare results.
- Time commitment
- The study involves 15 nights of home monitoring and additional lab visits for sleep tests.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 75
You may be able to join if
- 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...
- Hoehn and Yahr stage 2-3 (on medication, on DBS) at the time of enrollment
You likely can't join if
- 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...
- Shift workers
- Presence of any other condition that, in the opinion of the investigator, will preclude the participant from successfully or safely completing study...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.