Dystonia, Parkinson's Disease, Tremor
Conditions
Keywords
Parkinson's disease, Tremor, Dystonia, DBS, Sleep
Brief summary
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.
Interventions
OTHERAlteration of DBS stimulator settings
Alteration of DBS stimulator settings
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Efficiency | 1 month | This is the percentage of time the subject is in bed when he/she is actually asleep. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wake after sleep onset (WASO) | 1 month | This is a measurement of the amount of time during polysomnography recording that the subject is awake after their initial sleep onset. |
| Total Sleep Time | 1 month | — |
| Two timed motor tasks | 1 month | 1. The subject will tap index finger between 2 points 30 cm apart on the table for 10 seconds. 2. The subject will be timed as they rise from a chair, walk 7 meters, return to the chair, and sit down. |
Countries
United States
Outcome results
None listed