Globus Pallidus Stimulation to Treat Insomnia (GPS-I)

April 12, 2024 updated by: Pablo Castillo, Mayo Clinic

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adults with Parkinson's disease and severe insomnia
1 arm study
Device: DEEP BRAIN STIMULATION
NEUROMODULATION

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Insomnia Severity Index
Time Frame: 3 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)
3 and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Parkinson's Sleep Scale (PDSS)
Time Frame: 3 and 6 months
Change in self-reported Parkinson's Sleep Scale (PDSS) questionnaire, using a scale of 0 is always and 10 as never
3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Pablo Castillo, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

October 2, 2019

First Submitted That Met QC Criteria

October 3, 2019

First Posted (Actual)

October 7, 2019

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-010112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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