Recruiting

DBS

Sponsor:

Mayo Clinic

Code:

NCT04116996

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

DEEP BRAIN STIMULATION

Study Details

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).

Conditions

Parkinson Disease

Study ID

NCT04116996

Start date

Jan 1, 2019

Status verified date

Nov, 2025

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Adults with Parkinson's disease and severe insomnia

1 arm study

Interventions

DEEP BRAIN STIMULATION

NEUROMODULATION

Primary outcome measure

  • Change in Insomnia Severity Index [ Time Frame: 3 and 6 months ]

Central Contacts and Locations

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Pablo R Castillo, MD

904-9532000castillo.pablo@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Dec 1, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-12-01.