Improve sleep in Parkinson patients

Trial ID
NCT05962489
Official Title
Sleep-specific DBS Therapy in Parkinson's Disease
Goal
Improve sleep in Parkinson patients
Phase
NA
Status
RECRUITING
Sponsor
University of Minnesota
Study Type
INTERVENTIONAL
Enrollment
64 participants
Conditions
Deep Brain Stimulation, Parkinson's Disease and Parkinsonism, Dystonia
Interventions
Clinically optimized deep brain stimulation

Plain-Language Summary

The goal is to improve sleep in people with Parkinson's by using deep brain stimulation that is specifically tuned to sleep states, so stimulation can better regulate the brain circuits that disrupt normal sleep. The approach implants directional DBS leads bilaterally in either the globus pallidus interna or subthalamic nucleus as part of routine surgical care at the University of Minnesota, uses 7T imaging and sleep-focused programming and recordings, and adjusts electrical pulses to modulate abnormal neural activity during sleep. Participants must be adults 21 or older with idiopathic Parkinson's who are planning or have had bilateral GPi or STN DBS with directional leads at UMN and can undergo the required imaging, while people with dementia, other major neurological disorders, pregnancy, recent unsafe radiation exposure, or certain post-op complications are excluded.

Locations

  • University Of Minnesota, Minneapolis, Minnesota, United States

Frequently Asked Questions

What is this trial testing?
This trial is studying Clinically optimized deep brain stimulation. The goal is to improve sleep in people with Parkinson's by using deep brain stimulation that is specifically tuned to sleep states, so stimulation can better regulate the brain circuits that disrupt normal sleep. The approach implants directional DBS leads bilaterally in either the globus pallidus interna or subthalamic nucleus as part of routine surgical care at the University of Minnesota, uses 7T imaging and sleep-focused programming and recordings, and adjusts electrical pulses to modulate abnormal neural activity during sleep. Participants must be adults 21 or older with idiopathic Parkinson's who are planning or have had bilateral GPi or STN DBS with directional leads at UMN and can undergo the required imaging, while people with dementia, other major neurological disorders, pregnancy, recent unsafe radiation exposure, or certain post-op complications are excluded.
Who can participate?
Participants must be at least 21 Years.
Where is this trial located?
This trial is recruiting at 1 location.
Does it cost anything to join?
No. There is no cost to participate. Study-related care and treatment are provided at no charge.
How long does the trial last?
This trial is estimated to last approximately 4 years and 1 month.

View on ClinicalTrials.gov