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NCT02549859 · ClinicalTrials.gov registry record · NA
Long-term Effect of Low Frequency Stimulation on Aspiration and Freezing of Gait in PD With STN DBS
A NA study, sponsored by University of Chicago.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT02549859: Completed NA study, sponsored by University of Chicago.
NCT02549859 is a NA study that has completed, run by University of Chicago. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02549859, a NA study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
Our recent study (Xie et al, Neurology 2015; 84: 415-420) found that bilateral STN DBS of 60Hz, compared to the traditional 130Hz, decreased the aspiration frequency and swallowing difficulty, freezing of gait (FOG), and other axial symptoms and parkinsonism in Parkinson patients with FOG refractory to 130Hz and medications. The benefit of 60Hz stimulation persisted during the 6-week study period, but with worsening tremor in one patient. However, it remains unknown whether the benefit of 60Hz would persist on prolonged stimulation period, and whether there is carry-over effect across different conditions. Hence, the investigators would like to test the hypothesis that the 60Hz stimulation, compared to 130Hz might have persistent benefit over an extended period in reducing the swallowing dysfunction, FOG, and other axial symptoms in these PD patients even after correcting the potential carry-over effect.
Primary Outcome
A speech pathologist used the Penetration-Aspiration Scale (PAS) to rate swallows captured by a radiologist during VFSS recording. PAS is an 8-point interval scale: a score of 0 indicates no penetration or aspiration \& a score of 6-8 indicates aspiration of increasing severity. For the purpose of this study, aspiration was dichotomized to "0" if PAS score was under 6 or "1" if PAS score was between 6-8. Frequency of aspiration events was calculated by adding number of aspiration events in VFSS
Interventions
- DEVICE Deep Brain Stimulation (DBS) at 60 Hz
- DEVICE Deep Brain Stimulation (DBS) at 130 Hz
- DEVICE Deep Brain Stimulation (DBS) Off (Sham)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2015-08 |
| Est. Completion | 2017-05 |
| Phase | NA |
What the finished NCT02549859 record still lists
NCT02549859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Deep Brain Stimulation (DBS) at 60 Hz is the first listed.
NCT02549859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02549859 about?
NCT02549859 is a clinical study titled "Long-term Effect of Low Frequency Stimulation on Aspiration and Freezing of Gait in PD With STN DBS". Our recent study (Xie et al, Neurology 2015; 84: 415-420) found that bilateral STN DBS of 60Hz, compared to the traditional 130Hz, decreased the aspiration frequency and swallowing difficulty, freezing of gait (FOG), and other axial symptoms and parkinsonism in Parkinson patients with FOG refractory...
What is the current status of trial NCT02549859?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2015-08. Estimated completion is 2017-05.
What interventions are being tested in trial NCT02549859?
The interventions under investigation include: Deep Brain Stimulation (DBS) at 60 Hz (DEVICE), Deep Brain Stimulation (DBS) at 130 Hz (DEVICE), Deep Brain Stimulation (DBS) Off (Sham) (DEVICE).
Who is sponsoring clinical trial NCT02549859?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02549859's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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