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Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease

Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease - The DREAMS-PD Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
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

In plain language

This study looks at brain recordings during sleep while different deep brain stimulation (DBS) settings are used. It is for adults with Parkinson’s disease who already have a specific DBS device implanted on both sides of the brain.

This study employs an exploratory, prospective, single center, naturalistic clinical trial design with a randomized crossover intervention.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18.
  • Have idiopathic Parkinson’s disease, meaning the cause is unknown.
  • Have a Medtronic Percept PC DBS system on both sides of the brain, targeting an area called the subthalamic nucleus. Settings must have been adjusted for best results for at least 3 months.
  • Score at least 1 on question 1.7 of Part I of the MDS-UPDRS, a Parkinson’s disease rating scale.
  • Be able to walk without help.
  • Be able to understand the study and agree to take part.
  • If taking medicine to help with sleep, have the same dose for at least 30 days.

Who can't join

  • Have a brain or nerve disease other than Parkinson’s, such as stroke or multiple sclerosis.
  • Have narcolepsy, a sleep disorder that causes strong daytime sleepiness.
  • Have untreated moderate to severe sleep apnea, with breathing pauses or reduced breathing at least 15 times per hour.
  • Have uncontrolled restless legs syndrome, which causes an urge to move the legs.
  • Have dementia, based on formal testing of memory and thinking skills.
  • Have ongoing alcohol or drug abuse.
  • Work night shifts or irregular hours.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 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 Exclusion Criteria: * 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.

Study sites (1)

OH