Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2019-01-01
2029-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Adults with Parkinson's disease and severe insomnia
1 arm study
DEEP BRAIN STIMULATION
NEUROMODULATION
Interventions
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DEEP BRAIN STIMULATION
NEUROMODULATION
Eligibility Criteria
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Inclusion Criteria
* Symptomatic with Parkinsonism for 7-20 years
* Severe insomnia based on ISI score
Exclusion Criteria
* Hoehn \& Yahr \[Hoehn, 1967 #1839\] stage I or V disease
* Other significant neurological or psychiatric disease
* Previous pallidotomy or thalamotomy
* Previous placement of other implantable devices
* Secondary parkinsonism (non-idiopathic parkinsonism)
* Inability to travel to Jacksonville for post-operative study visits
* Severe sleep apnea
* Insomnia due to pain or untreated mood disorder
* Contraindications to 3T MRI
* Circadian rhythm sleep disorders.
* Current use of hypnotics
40 Years
80 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Pablo Castillo
Principal Investigator
Principal Investigators
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Pablo Castillo, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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17-010112
Identifier Type: -
Identifier Source: org_study_id
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