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Procedure

Deep Brain Stimulation for Insomnia (GPS-I Trial)

N/A
Recruiting
Led By Pablo Castillo, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Severe insomnia based on ISI score
40-80 years of age
Must not have
Previous pallidotomy or thalamotomy
Secondary parkinsonism (non-idiopathic parkinsonism)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a brain stimulator can improve insomnia by zapping a different area of the brain.

Who is the study for?
This trial is for people aged 40-80 with Parkinson's Disease who've had symptoms for 7-20 years and suffer from severe insomnia. They shouldn't have dementia, previous brain surgeries like pallidotomy or thalamotomy, be using sleeping pills, or have other major neurological issues. Also, they must be able to visit Jacksonville for follow-ups.
What is being tested?
The study is testing if activating an extra DBS electrode targeting the globus pallidus externa in the brain can help improve sleep in Parkinson's patients. It involves unilateral deep brain stimulation as a potential treatment for insomnia.
What are the potential side effects?
While not specified here, common side effects of deep brain stimulation may include headache, dizziness, nausea, and possible changes in mood or thinking patterns. There might also be risks associated with surgery such as infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe trouble sleeping.
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I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a previous brain surgery for movement disorders.
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My Parkinson's disease is caused by another condition.
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My Parkinson's disease is at an early or very advanced stage.
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I have been diagnosed with severe sleep apnea.
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I have trouble sleeping because of pain or an untreated mood disorder.
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I do not have any major neurological or psychiatric conditions.
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I have a disorder affecting my sleep-wake cycle.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Insomnia Severity Index
Secondary study objectives
Change in Parkinson's Sleep Scale (PDSS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Adults with Parkinson's disease and severe insomniaExperimental Treatment1 Intervention
1 arm study

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,337 Previous Clinical Trials
3,061,164 Total Patients Enrolled
Pablo Castillo, MDPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital Jacksonville
University De Guayaquil (Medical School)
Mayo Grad School Med/Mayo Fndn (Residency)

Media Library

Globus Pallidus Stimulation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04116996 — N/A
Overactive Bladder Research Study Groups: Adults with Parkinson's disease and severe insomnia
Overactive Bladder Clinical Trial 2023: Globus Pallidus Stimulation Highlights & Side Effects. Trial Name: NCT04116996 — N/A
Globus Pallidus Stimulation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04116996 — N/A
~0 spots leftby Jan 2025
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