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Globus Pallidus Stimulation for Insomnia in Parkinson's Disease

This study is exploring if Deep Brain Stimulation (DBS) to a specific brain area called the globus pallidus externa (GPe) can help improve insomnia (sleep problems) in people with Parkinson's disease. Researchers will turn on an additional DBS electrode in this area and see if it makes a difference. You might be able to join if you are 40-80 years old, have had Parkinson's disease for 7-20 years, and experience severe insomnia. We will measure changes in your insomnia using a tool called the Insomnia Severity Index after 3 and 6 months. The study aims to enroll 10 participants, but its current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 10 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in insomnia at 3 and 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04116996

Globus Pallidus Stimulation to Treat Insomnia

Recruiting
NAAges 40–80InterventionalTreatment
Mayo Clinic
~10 participants
Updated 2025-12-01 on ClinicalTrials.gov
What's tested:DEEP BRAIN STIMULATION

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Insomnia Severity Index
Measured over 3 and 6 months

Conditions

Parkinson Disease

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NCT04116996

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Florida

    Jacksonville, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Pablo Castillo, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Pablo R Castillo, MD
[email protected]
904-9532000
Email the study team

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Eligibility criteria

Inclusion

40-80 years of age
Symptomatic with Parkinsonism for 7-20 years
Severe insomnia based on ISI score

Exclusion

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

What this trial measures

  • Change in Insomnia Severity Index3 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)