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NCT Number: NCT04116996

Globus Pallidus Stimulation to Treat Insomnia

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).

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location status: Recruiting

Location contact

Pablo R Castillo, MD

CONTACT

[email protected]

904-9532000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep brain stimulation

Device

NEUROMODULATION

Primary outcomes

  1. Change in Insomnia Severity Index

    Time frame: 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 outcomes

  1. Change in Parkinson's Sleep Scale (PDSS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: GPS-I

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Oct 7, 2019
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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