Completed

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

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What is being tested

Alteration of DBS stimulator settings

Other
Who is being recruted

Synucleinopathies+12

+ Basal Ganglia Diseases

+ Brain Diseases

Over 19 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: July 2010
See protocol details

Summary

Principal SponsorUniversity of Alabama at Birmingham
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 15, 2010

Actual date on which the first participant was enrolled.

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.

Official TitleEffect of DBS on Sleep Architecture in Patients With Movement Disorders.
NCT01169324
Principal SponsorUniversity of Alabama at Birmingham
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

17 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesDystoniaMovement DisordersNervous System DiseasesNeurologic ManifestationsParkinson DiseaseSigns and SymptomsPathological Conditions, Signs and SymptomsTremorNeurodegenerative DiseasesParkinsonian DisordersDyskinesias

Criteria

3 inclusion criteria required to participate
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.
3 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
baseline settings

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Alabama at Birmingham

Birmingham, United StatesOpen University of Alabama at Birmingham in Google Maps
CompletedOne Study Center