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NCT01769690 · ClinicalTrials.gov registry record · NA

The Effect of Low Frequency STN DBS on Sleep and Vigilance in Parkinson's Disease (PD) Patients

A NA study of Parkinson's Disease, sponsored by University of Alabama at Birmingham.

Completed
Registry status
NA
Development phase
20
Enrollment target
1
Study location

NCT01769690: Completed NA study of Parkinson's Disease, sponsored by University of Alabama at Birmingham.

NCT01769690 is a NA study of Parkinson's Disease that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 20 participants, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01769690, a NA study of Parkinson's Disease, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

The study design is a within-subject randomized cross-over design to evaluate the effects of DBS on sleep architecture, as measured by polysomnography, and on wake-time vigilance, as measured by a virtual reality street-crossing simulator.

Primary Outcome

Phase I subjects will undergo 2 sleep studies, one with the stimulator "on" at the subject's stable, clinically effective settings and one with the stimulator "off." Phase 2 subjects will spend the first night in the sleep lab with DBS turned off. The order of the high and low frequency nights (on the second and third study nights) will be randomized.

Conditions Studied

Interventions

  • OTHER DBS stimulator setting alteration
  • OTHER virtual reality simulator

Study Locations (1)

Alabama

  • University of Alabama at Birmingham - Birmingham

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2012-12
Est. Completion 2020-02
Phase NA
University of Alabama at Birmingham

1,160 total trials

What the finished NCT01769690 record still lists

NCT01769690 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (97% lower).

The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions - of which DBS stimulator setting alteration is the first listed.

NCT01769690 reports a single indexed study location in Alabama.

Frequently Asked Questions

What is clinical trial NCT01769690 about?

NCT01769690 is a clinical study titled "The Effect of Low Frequency STN DBS on Sleep and Vigilance in Parkinson's Disease (PD) Patients". The study design is a within-subject randomized cross-over design to evaluate the effects of DBS on sleep architecture, as measured by polysomnography, and on wake-time vigilance, as measured by a virtual reality street-crossing simulator.

What is the current status of trial NCT01769690?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2012-12. Estimated completion is 2020-02.

What conditions does trial NCT01769690 study?

This clinical trial studies the following conditions: Parkinson's Disease.

What interventions are being tested in trial NCT01769690?

The interventions under investigation include: DBS stimulator setting alteration (OTHER), virtual reality simulator (OTHER).

Who is sponsoring clinical trial NCT01769690?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01769690 being conducted?

This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Parkinson's Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01769690's enrollment target sits among peer trials

20 129th of 158 higher than 24 of 158 other Parkinson's Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Parkinson's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01769690, the US trial registry maintained by the National Library of Medicine. NCT01769690 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.