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Testing an extra brain stimulation setting for insomnia

Researchers study whether turning on an additional stimulation electrode in a specific brain area affects difficulty sleeping.

Testing a treatment or activity · Study reference: NCT04116996

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

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Start (reported actual date)
2019-01-01
Main measurements finished (planned)
2029-01-01
Study finished (planned)
2029-01-01

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 40 years to 80 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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
Full study name & original research details

Official study title

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

Short title used by the registry

Globus Pallidus Stimulation to Treat Insomnia

Original description

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 reported: Parkinson Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
DEEP BRAIN STIMULATION
Phases
NA
Sponsor
Mayo Clinic
Start date reported by registry
2019-01-01 (actual)

Registry updated: 2025-12-01 · Status last verified by the registry submitter: 2025-11

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

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Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

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Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Mayo Clinic in Florida

Jacksonville, Florida, United States

Recruiting

Pablo R Castillo, MD · 904-9532000 · castillo.pablo@mayo.edu

Facility not reported

United States

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.