Globus Pallidus Stimulation to Treat Insomnia | NCT04116996

Studies
Globus Pallidus Stimulation to Treat Insomnia

NCT04116996

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

Dec 1, 2025Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Parkinson Disease

Interventions

DEEP BRAIN STIMULATION

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jan 1, 2029Estimated

Completion Date

Jan 1, 2029Estimated

First Submitted Date

Oct 2, 2019

First Submission Date that Met QC Criteria

Oct 3, 2019

First Posted Date

Oct 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2025

Last Update Posted Date

Dec 1, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adults with Parkinson's disease and severe insomnia	Experimental	1 arm study	Device: DEEP BRAIN STIMULATION

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DEEP BRAIN STIMULATION	Device	NEUROMODULATION	Adults with Parkinson's disease and severe insomnia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	3 and 6 months

Secondary Outcomes

Measure	Description	Time Frame
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	3 and 6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pablo Castillo, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Florida	Recruiting	Jacksonville	Florida	32224	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D046690	Deep Brain Stimulation

Ancestor Terms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided