Parkinson DiseaseGPS-INCT04116996
Globus Pallidus Stimulation to Treat Insomnia
A study testing DEEP BRAIN STIMULATION in people with Parkinson Disease, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- DEEP BRAIN STIMULATION
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40-80 years of age
- Symptomatic with Parkinsonism for 7-20 years
- Severe insomnia based on ISI score
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Pablo R Castillo, MD, 904-9532000, castillo.pablo@mayo.edu
About this study
Official title: 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).
- Conditions
- Parkinson Disease
- Being tested
- DEEP BRAIN STIMULATION
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEEP BRAIN STIMULATIONDevice
NEUROMODULATION
| Study group | Role | What they receive |
|---|---|---|
| Adults with Parkinson's disease and severe insomnia | Experimental | 1 arm study Receives: Device: DEEP BRAIN STIMULATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 and 6 months
Secondary outcomes (1)
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
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Castillo, Mayo Clinic
- Investigators
- Pablo Castillo, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116996
- Sponsor's protocol ID
- 17-010112
- Acronym
- GPS-I
- Status last verified
- Nov 2025
- First submitted
- 2 Oct 2019
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulation of the External Pallidal Segment for Insomnia in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04116996
- Acronym / sponsor ID
- GPS-I / 17-010112
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with Parkinson's disease and severe insomnia | Experimental | Device: DEEP BRAIN STIMULATION1 arm study |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40-80 years of age
- Symptomatic with Parkinsonism for 7-20 years
- Severe insomnia based on ISI score
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEEP BRAIN STIMULATIONNEUROMODULATION | Device | Adults with Parkinson's disease and severe insomnia |
Primary outcome
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)
1 secondary outcome
Change in Parkinson's Sleep Scale (PDSS)
Time frame: 3 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pablo Castillo, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEEP BRAIN STIMULATION in people with Parkinson Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.