Effect of Deep Brain Stimulation (DBS) on Sleep Architecture in Patients With Movement Disorders



Status:Active, not recruiting
Conditions:Parkinsons Disease, Neurology, Orthopedic
Therapuetic Areas:Neurology, Orthopedics / Podiatry
Healthy:No
Age Range:19 - Any
Updated:4/17/2018
Start Date:July 2010
End Date:June 2019

Use our guide to learn which trials are right for you!

Effect of DBS on Sleep Architecture in Patients With Movement Disorders.

The purpose of this prospective, participant-blinded trial is to determine the changes in
sleep architecture in a cohort of subjects who have undergone deep brain stimulation (DBS)
surgery for treatment of movement disorders such as moderate to advanced Parkinson's disease
(PD), tremor, or dystonia. Our preliminary observational data suggest that unilateral
subthalamic nucleus (STN) DBS improves subjective sleep quality in PD patients 6 months after
the procedure. The cause of this improvement in sleep quality is unknown, and this study
proposes the use of polysomnography (PSG) to test whether the improvement in sleep is
independent of improvement in night-time mobility associated with DBS treatment of the motor
symptoms of PD, tremor, or dystonia.


Inclusion Criteria:

- Prior DBS surgery for treatment of movement disorders such as PD, tremor, or dystonia.

- Stable DBS stimulator settings and medication regimen for at least 6 weeks prior to
the sleep studies.

- Sleep dysfunction as measured by the Pittsburgh Sleep Quality Index (PSQI) (score >5)
at the subject's baseline pre-surgical evaluation.

Exclusion Criteria:

- Known narcolepsy

- Other previous surgical treatment of Parkinson's disease, tremor, or dystonia (with
the exception of DBS) including pallidotomy, thalamotomy, or gene therapy procedures.

- Untreated obstructive sleep apnea. If obstructive sleep apnea is discovered during the
first sleep study, the subject will be removed from the study. After they have been
treated for at least 6 weeks with CPAP, they can re-start the study.
We found this trial at
1
site
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials