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

NCT01169324 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-04-26

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Alteration of DBS stimulator settings

Alteration of DBS stimulator settings

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Amy W Amara, MD, phD · UAB Neurology

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-15
Primary Completion
2015-12-11
Completion
2015-12-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01169324 on ClinicalTrials.gov