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Sleep-specific DBS Therapy in Parkinson's 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
21 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

  • Visits mentioned: 12 visits
  • Procedures mentioned: MRI scans, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants in both studies will have received a 7 Tesla MRI scan (either as part of their regular clinical treatment, or as part of a different study, run by Dr."
  • "All patients will undergo standard-of-care pre-surgery UPDRS-III exams, sleep-specific exams including the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and REM Sleep Behavior Disorder Questionnaire (RBDSQ)."
  • "Follow-up Sleep rating scales will be collected at their standard of care 6 and 12 month visits."
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 sleep problems in people with Parkinson’s disease and how deep brain stimulation (DBS) affects sleep and brain activity. DBS uses an implanted device to send electrical signals to the brain. The study is for adults with Parkinson’s who have or plan to have certain DBS surgery at the University of Minnesota (UMN).

Sleep-wake disturbances are a major factor associated with reduced quality of life of individuals with Parkinson's disease (PD), a progressive neurological disorder affecting millions of people in the U.S and worldwide. The brain mechanisms underlying these sleep disorders, and the effects of therapeutic interventions such as deep brain stimulation on sleep-related neuronal activity and sleep behavior, are not well understood. Results from this study will provide a better understanding of the brain circuitry involved in disordered sleep in PD and inform the development of targeted therapeutic interventions to treat sleep disorders in people with neurodegenerative disease.

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

Eligibility

Who can join

  • Have idiopathic Parkinson’s disease, meaning its cause is unknown.
  • Be at least 21 years old.
  • Have had or plan to have a 7T brain scan, which uses a strong magnet.
  • Plan to have DBS surgery at UMN as part of your usual care, using wires that direct signals to brain areas called GPi or STN.
  • Plan to have this DBS system placed on both sides of the brain, or already have it with the first device-setting visit at least 2 weeks away.

Who can't join

  • Have another major brain or nerve disorder.
  • Have a history of dementia, which causes problems with memory and thinking.
  • Have problems after surgery or side effects that make the study unsafe or affect its results, such as muscle twisting caused by stimulation.
  • Be pregnant.
  • Have known radiation exposure in the past year that would be unsafe when added to the X-rays used during surgery to place a brain-recording strip.

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

Official eligibility criteria

Inclusion criteria: * Diagnosis of idiopathic PD * At least 21 years old * Existing or planned 7T brain imaging * Surgery at UMN to implant DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care * Surgery at UMN to implant bilateral DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care (or has already occurred, as long as the initial programming session is at least 2 weeks away) Exclusion criteria: * Other significant neurological disorder * History of dementia * Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study * Pregnant women * Known radiation exposure within the last year that is determined to be unsafe when compounded with the expected radiation dose from intraoperative fluoroscopy to place ECoG strip

Study sites (1)

MN