No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
21 and older
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
64 (estimated)
Sponsor
University of Minnesota · Other
Who this trial is looking for
This trial is looking for people with Parkinson's disease who need a deep brain stimulation procedure to help with sleep issues. Participants will have brain imaging and surgery as part of their routine care at the University of Minnesota.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Parkinson's disease.
I am at least 21 years old.
I have existing or planned 7T brain imaging.
I am scheduled for deep brain stimulation surgery at UMN.
I have a scheduled initial programming session in at least 2 weeks.
You may not be able to join if
I have another significant neurological disorder.
I have a history of dementia.
I have had post-operative complications affecting my safety.
I am pregnant.
I have had unsafe radiation exposure in the last year.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 beha…
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.
Trial Locations
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Status
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 wi…
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
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