Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
All Genders
NCT04116996

Globus Pallidus Stimulation to Treat Insomnia

Led by Mayo Clinic · Updated on 2025-12-01

10

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

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).

CONDITIONS

Official Title

Globus Pallidus Stimulation to Treat Insomnia

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 40 and 80 years
  • Parkinsonism symptoms lasting 7 to 20 years
  • Severe insomnia based on Insomnia Severity Index score
Not Eligible

You will not qualify if you...

  • Clinically significant dementia with MMSE score less than 23
  • Hoehn & Yahr stage I or V Parkinson's disease
  • Other major neurological or psychiatric diseases
  • Previous pallidotomy or thalamotomy brain surgeries
  • Previous placement of other implantable devices
  • Secondary (non-idiopathic) parkinsonism
  • Inability to travel to Jacksonville for study visits
  • Severe sleep apnea
  • Insomnia caused by pain or untreated mood disorders
  • Contraindications to 3T MRI
  • Circadian rhythm sleep disorders
  • Current use of hypnotic medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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