This trial is active, not recruiting.

Conditions parkinson's disease, tremor, dystonia
Treatment alteration of dbs stimulator settings
Sponsor University of Alabama at Birmingham
Start date July 2010
End date December 2016
Trial size 17 participants
Trial identifier NCT01169324, F100528004


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator)
baseline settings
alteration of dbs stimulator settings
Alteration of DBS stimulator settings
(No Intervention)
DBS off

Primary Outcomes

Sleep Efficiency
time frame: 1 month

Secondary Outcomes

Wake after sleep onset (WASO)
time frame: 1 month
Total Sleep Time
time frame: 1 month
Two timed motor tasks
time frame: 1 month

Eligibility Criteria

Male or female participants at least 19 years old.

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.

Additional Information

Official title Effect of DBS on Sleep Architecture in Patients With Movement Disorders.
Principal investigator Amy W Amara, MD, phD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Alabama at Birmingham.