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RECRUITINGINTERVENTIONAL

Globus Pallidus Stimulation to Treat Insomnia

Stimulation of the External Pallidal Segment for Insomnia in Patients With Parkinson's Disease

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 40-80 years of age - Symptomatic with Parkinsonism for 7-20 years - Severe insomnia based on ISI score Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

DEEP BRAIN STIMULATION

NEUROMODULATION

Locations (1)

Mayo Clinic in Florida
Jacksonville, Florida, United States