Sleep-specific DBS Therapy in Parkinson's Disease

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT05962489
Status
Recruiting
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Conditions

  • Deep Brain Stimulation
  • Dystonia
  • Parkinson's Disease and Parkinsonism

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Clinically optimized deep brain stimulation — OTHER
    Participants will have DBS implanted as standard-of-care. We will be examining the effects of their regular clinical stimulation settings versus no stimulation.

Study Details

Sleep-wake disturbances are a major factor associated with reduced quality of life of individuals with Parkinson's disease (PD), a progressive neurological disorder affecting millions of people in the U.S and worldwide. The brain mechanisms underlying these sleep disorders, and the effects of therapeutic interventions such as deep brain stimulation on sleep-related neuronal activity and sleep behavior, are not well understood. Results from this study will provide a better understanding of the brain circuitry involved in disordered sleep in PD and inform the development of targeted therapeutic interventions to treat sleep disorders in people with neurodegenerative disease.

Key Dates

Start date
Jun 22, 2023
Status verified
Mar 2026
Primary completion
Aug 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
64 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: OFF DBS followed by ON DBS
  • Experimental: ON DBS followed by OFF DBS

Primary Outcome Measure

pallidopeduncular and pedunculopallidal pathway activation [ Time Frame: 6 months post DBS surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Of MinnesotaMinneapolisMinnesota55455
Luke Johnson, PhD
[email protected]
612-625-9900

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By research site
University Of Minnesota· Minneapolis, MN

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