Globus Pallidus Stimulation to Treat Insomnia

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT04116996
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • DEEP BRAIN STIMULATION — DEVICE
    NEUROMODULATION

Study Details

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).

Key Dates

Start date
Jan 1, 2019
Status verified
Nov 2025
Primary completion
Jan 1, 2029
Completion
Jan 1, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adults with Parkinson's disease and severe insomnia
    1 arm study

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224
Pablo R Castillo, MD
904-9532000

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