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Globus Pallidus Stimulation to Treat Insomnia (GPS-I)

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DEEP BRAIN STIMULATION
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in FloridaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adults with Parkinson's disease and severe insomnia

Arm Description

1 arm study

Outcomes

Primary Outcome Measures

Change in Insomnia Severity Index
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)

Secondary Outcome Measures

Change in Parkinson's Sleep Scale (PDSS)
Change in self-reported Parkinson's Sleep Scale (PDSS) questionnaire, using a scale of 0 is always and 10 as never

Full Information

First Posted
October 2, 2019
Last Updated
February 14, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04116996
Brief Title
Globus Pallidus Stimulation to Treat Insomnia
Acronym
GPS-I
Official Title
Stimulation of the External Pallidal Segment for Insomnia in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adults with Parkinson's disease and severe insomnia
Arm Type
Experimental
Arm Description
1 arm study
Intervention Type
Device
Intervention Name(s)
DEEP BRAIN STIMULATION
Intervention Description
NEUROMODULATION
Primary Outcome Measure Information:
Title
Change in Insomnia Severity Index
Description
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)
Time Frame
3 and 6 months
Secondary Outcome Measure Information:
Title
Change in Parkinson's Sleep Scale (PDSS)
Description
Change in self-reported Parkinson's Sleep Scale (PDSS) questionnaire, using a scale of 0 is always and 10 as never
Time Frame
3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Castillo, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo R Castillo, MD
Phone
904-953-2000
Email
castillo.pablo@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Globus Pallidus Stimulation to Treat Insomnia

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