Globus Pallidus Stimulation to Treat Insomnia (GPS-I)

Mayo Clinic

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Device: DEEP BRAIN STIMULATION

Study type: Interventional

Funder types: Other

Identifiers

NCT04116996

17-010112

Details and patient eligibility

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).

Enrollment: 10 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Adults with Parkinson's disease and severe insomnia

Experimental group

Description:

1 arm study

Treatment:

Device: DEEP BRAIN STIMULATION