Globus Pallidus Stimulation to Treat Insomnia
Recruiting · NCT04116996 · Interventional (participants receive a specific treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
DEEP BRAIN STIMULATION
What this trial is about
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).
Who can take part
Age range
40 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Mayo Clinic in Florida - Jacksonville, Florida, United States