Parkinson Disease
Conditions
Brief summary
Researchers are to determine if turning on an additional unilateral DBS (deep brain stimulation) electrode with stimulation to the globus pallidus externa (GPe) region of the brain will improve insomnia (sleep).
Interventions
DEVICEDEEP BRAIN STIMULATION
NEUROMODULATION
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 40-80 years of age * Symptomatic with Parkinsonism for 7-20 years * Severe insomnia based on ISI score
Exclusion criteria
* Clinically significant dementia (MMSE \<23) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insomnia Severity Index | 3 and 6 months | Change in self-reported insomnia severity index questionnaire score, using a total score scale of 0-7 is no clinically significant insomnia, 8-14 is subthreshold insomnia, 15-21 is clinical insomnia (moderate severity), 22-28 is Clinical insomnia (severe) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Parkinson's Sleep Scale (PDSS) | 3 and 6 months | Change in self-reported Parkinson's Sleep Scale (PDSS) questionnaire, using a scale of 0 is always and 10 as never |
Countries
United States
Outcome results
None listed