Globus Pallidus Stimulation to Treat Insomnia

Parkinson Disease Clinical Trial

— GPS-I  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04116996
• Other study ID #: 17-010112
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• DEEP BRAIN STIMULATION
NEUROMODULATION

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insomnia Severity Index	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)	3 and 6 months
Secondary	Change in Parkinson's Sleep Scale (PDSS)	Change in self-reported Parkinson's Sleep Scale (PDSS) questionnaire, using a scale of 0 is always and 10 as never	3 and 6 months