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NCT01935011 · ClinicalTrials.gov registry record
DBS Frequency on Swallowing Function in Parkinson's Disease
A clinical trial, sponsored by University of Chicago.
- Completed
- Registry status
- 7
- Enrollment target
NCT01935011: Completed study, sponsored by University of Chicago.
NCT01935011 is a clinical trial that has completed, run by University of Chicago. The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01935011 has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- 7 participants
- Enrollment target
Study Summary
The stimulation frequency has been found to affect the axial symptoms of freezing of gait (FOG) and speech in advanced Parkinson's disease (PD) patients with subthalamic nucleus deep brain stimulation (STN DBS), with the traditionally high stimulation frequency of 130 Hz worsening while low frequency of 60 Hz improving these symptoms. The effect of stimulation frequency on another important axial symptom, swallowing dysfunction, has not been studied. The investigators hypothesize that stimulation frequency could have similar effect on swallowing function.
Primary Outcome
Eight PD patients with STN DBS and FOG responsive to stimulation frequency changes will be enrolled. Information on the oropharyngeal motility study (OPMS) of the oral, pharyngeal and esophageal phase function will be collected, under "Med on/DBS off", "Med on/DBS 130 Hz", or "Med on/DBS 60 Hz". Each patient will be randomly assigned to these three conditions in a double blinded manner of 30 minutes apart. The patients will be reassessed under the single best condition (likely Med on/DBS 60 Hz)
Interventions
- OTHER PD, DBS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-07 |
What the finished NCT01935011 record still lists
NCT01935011 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 7 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which PD, DBS is the first listed.
NCT01935011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01935011 about?
NCT01935011 is a clinical study titled "DBS Frequency on Swallowing Function in Parkinson's Disease". The stimulation frequency has been found to affect the axial symptoms of freezing of gait (FOG) and speech in advanced Parkinson's disease (PD) patients with subthalamic nucleus deep brain stimulation (STN DBS), with the traditionally high stimulation frequency of 130 Hz worsening while low frequenc...
What is the current status of trial NCT01935011?
This trial is currently completed. The enrollment target is 7 participants. The study started on 2013-08. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01935011?
The interventions under investigation include: PD, DBS (OTHER).
Who is sponsoring clinical trial NCT01935011?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
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