Subcortical Oscillations in Human Sleep Dysregulation



Status:Recruiting
Conditions:Parkinsons Disease, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 80
Updated:4/17/2018
Start Date:February 27, 2018
End Date:December 31, 2021
Contact:Pamela David Gerecht, Ph.D.
Email:pamela.davidgerecht@ucdenver.edu
Phone:303-724-4134

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Understanding the Role of Subcortical Oscillations in Human Sleep Dysregulation.

Sleep problems are common in the United States (US) adult population (>50 million), and have
a negative impact on quality of life, productivity, and healthcare. A major obstacle to
understanding how the brain is involved in human sleep disorders has been the lack of
recordings of human brain function, from inside the brain, during the known sleep states.

Sleep is necessary for life; critically important to the regulation of body and brain
function. Sleep problems are common in the U.S. adult population (>50 million), and have a
negative impact on quality of life, productivity, and healthcare. A major obstacle to
understanding how the brain is involved in human sleep disorders has been the lack of
recordings of brain function, from inside the brain, during the known sleep states; non-rapid
eye movement (NREM) and rapid eye movement (REM). It is very common for patients with
Parkinson's disease (PD) to also have sleep disorders, such as insomnia,
restless-leg-syndrome and REM-behavior disorder. One treatment for PD patients is deep brain
stimulation (DBS) of the subthalamic nucleus (STN-DBS). Despite evidence showing that STN-DBS
improves several aspects of sleep behavior in PD subjects, few studies have examined the
relationship between brain activity and sleep regulation in human subjects. In this proposal,
the investigators will examine sleep in humans by recording brain activity from STN of PD
patients who have undergone DBS surgery. The investigators will also test the hypothesis that
STN contributes to both the regulation and disruption of normal sleep behavior.

Inclusion Criteria:

Subjects with Parkinson's Disease (PD) who are planning to have staged, bilateral deep
brain stimulation surgery at the University of Colorado Hospital and willing and able to do
the following:

1. Have a computer and be willing to use it as part of this study.

2. Be able to learn to use and maintain a wristband-style sleep monitor.

3. Turn off their Implantable Pulse Generator (IPG, implanted battery).

4. Wear a wristband-style sleep monitor for 3 weeks, 6 weeks prior to surgery.

5. Spend one overnight research stay in the UCH Sleep lab, 3 weeks prior to DBS surgery .

6. Spend one overnight research stay in the UCH Sleep lab, immediately prior to IPG
surgery, to record brain activity from the DBS electrode .

7. Have a 15 minute surgery to externalize the DBS lead cable to allow overnight
recordings to occur.

8. Be pseudo-randomized to one of 2 conditions: OFF stimulation or ON stimulation.

9. Wear a wristband-style sleep monitor for 3 weeks, 3 months post-DBS surgery, in one of
the 2 pseudo-randomized conditions.

10. Spend one overnight research stay in the UCH Sleep lab, 4 months post DBS surgery, in
one of the pseudo-randomized conditions.

Subjects will have a sleep disorder documented in their medical history as determined by a
single question screen for REM sleep behavior disorder.

Exclusion Criteria:

1. Subjects with Parkinson's Disease (PD) who are not planning to have staged, bilateral
deep brain stimulation surgery at the University of Colorado Hospital.

2. Subjects without a documented sleep disorder.
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Aurora, Colorado 80045
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