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

NCT01169324 | Completed

• 1 other identifier: F100528004
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Tremor; Dystonia

Keywords

Parkinson's disease; Tremor; Dystonia; DBS; Sleep

Outcome Measures

Primary Outcomes (1)

• Sleep Efficiency

  This is the percentage of time the subject is in bed when he/she is actually asleep.

  1 month

Secondary Outcomes (3)

• Wake after sleep onset (WASO)

  1 month

• Total Sleep Time

  1 month

• Two timed motor tasks

  1 month

Study Arms (2)

DBS on

EXPERIMENTAL

baseline settings

Other: Alteration of DBS stimulator settings

DBS off

NO INTERVENTION

DBS off

Interventions

Alteration of DBS stimulator settings OTHER

Alteration of DBS stimulator settings

DBS on

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Tremor; Dystonia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amy W Amara, MD, phD

  UAB Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: July 2, 2010
• First Posted: July 26, 2010
• Study Start: July 15, 2010
• Primary Completion: December 11, 2015
• Study Completion: December 11, 2015
• Last Updated: April 26, 2019

Record last verified: 2019-04

Locations

US (1)