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

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Tremor
Dystonia
Parkinson's Disease

Treatments

Other: Alteration of DBS stimulator settings

Study type

Interventional

Funder types

Other

Identifiers

NCT01169324
F100528004

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

17 participants in 2 patient groups

DBS on
Experimental group
Description:
baseline settings
Treatment:
Other: Alteration of DBS stimulator settings
DBS off
No Intervention group
Description:
DBS off

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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