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Recruiting NCT04116996

Globus Pallidus Stimulation to Treat Insomnia

No phase Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DEEP BRAIN STIMULATION.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Device DEEP BRAIN STIMULATION
    NEUROMODULATION

Primary outcome measures

  • Change in Insomnia Severity Index [Time frame: 3 and 6 months]
Secondary outcome measures (1)
  • Change in Parkinson's Sleep Scale (PDSS) [Time frame: 3 and 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Florida — Jacksonville

Identifiers

NCT: NCT04116996 · 17-010112

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗