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NCT04116996 | RECRUITING | Parkinson Disease

Globus Pallidus Stimulation to Treat Insomnia
Sponsor:

Mayo Clinic

Information provided by (Responsible Party):

Pablo Castillo

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).

Condition or disease

Parkinson Disease

Intervention/treatment

DEEP BRAIN STIMULATION

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Stimulation of the External Pallidal Segment for Insomnia in Patients With Parkinson's Disease
Actual Study Start Date : 2019-01-01
Estimated Primary Completion Date : 2029-01-01
Estimated Study Completion Date : 2029-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Globus Pallidus Stimulation to Treat Insomnia

Location Details

NCT04116996

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Locations

RECRUITING

United States, Florida

Mayo Clinic in Florida

Jacksonville, florida, United States, 32224