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New treatment option for Parkinson Disease
Official title Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease
ClinicalTrials.gov ID: NCT07110376
What this study is testing
- What it's testing
- This study employs an exploratory, prospective, single center, naturalistic clinical trial design with a randomized crossover intervention.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Demonstrate ability to ambulate independently;
You likely can't join if
- 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...
- Cognitive impairment meeting the criteria for dementia as per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), based...
- Ongoing alcohol or substance abuse; Working night shifts or irregular work hours The main concern for vulnerable people will be for the possibility...
See the full eligibility criteria
- 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...
- 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
- 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 people will be for the possibility of reduced decision-making capacity. For this we intend to exclude...
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, 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 - 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.